European Org and Treatmen by liwenting

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             2009 - 2010

                                   and Treat

    The EORTC: Developing practice-changing academic research
    for personalized patient care in oncology

    I would like to start this foreword by thanking the former EORTC Board and EORTC Headquarters
    for their outstanding contribution to the development of the EORTC over the last 3 years. Through
    their dedication and vision, the EORTC has consolidated its position at the forefront of academic
    clinical and translational research in Europe and Worldwide.
    We still need to further develop the EORTC within the rapidly changing landscape of oncology
    characterized by a better understanding of the biology of tumours, the development of molecular
    diagnostics, evolving paradigms for drug development and collaborations with pharmaceutical industry,
    the growing need to develop links with other clinical research networks in other continents, and the
    challenges of medical demography.

2   In 2009, the cancer patient should be more than ever at the centre of the networks of care and
    research. To establish future state of the art treatments, we not only need to be a top level global
    academic clinical research organisation, but also to efficiently integrate translational research, to
    further reinforce efficient and rapid collaboration processes with pharmaceutical industry partners,
    and to establish links with other academic networks.
    Building upon successful past initiatives, the EORTC Network now benefits from a very efficient
    Headquarters organisational structure which has enabled the implementation of innovative approaches
    that strengthen its research partnerships.
    Developing the new generation of academic clinical trials and partnerships with pharmaceutical
    industry for establishing new standards of care
    Molecular characterisation of the tumour will drive future clinical trials, and the EORTC will
    further reinforce its strategy, be engaged in innovative research programs, and will conduct pivotal
    multidisciplinary large-scale clinical trials to address relevant medical scientific questions with a strong
    translational research component. This allows for the prioritisation of resources and facilitates the
    development of clinico-genomic and “niche” clinical trials, thereby increasing the success of discovering
    and developing new standards of care.
    A centralised, independent EORTC tumour bio-bank facility linked to an electronic patient treatment
    outcome database as well as quality assurance in radiotherapy have been established. and an imaging
    platform for functional imaging is being set up.
    The Network of Core Institutions, NOCI, represents an extraordinary potential and guarantees
    the future of independent academic clinico-genomic cancer research in Europe. NOCI, dedicated
    to high quality innovative translational research and multi-tumour type trials, is already providing
    an innovative translational and clinical platform enabling efficient collaboration with partners in the
    pharmaceutical industry. Promising agents from early multi-tumour trials will be prioritised for further
    development and streamlined for validation in large phase III EORTC clinical trials.
EORTC Network as a platform for European and worldwide intergroup collaborations
The increasing complexity of innovative clinical trials will require the EORTC to liaise with other
partner academic research networks. Frequent tumour types are becoming increasingly fragmented
in more homogenous molecular subcategories and now pose challenges previously encountered only
in “rare” tumour types. For large clinical trials in the frequent tumour types, as well as for small
focused clinical trials in well characterized models, we will need international collaborations beyond
the EORTC Network. This has already been initiated in established collaborations with national and
international research groups. Further expanding these collaborations will be important.
Promoting young researchers and innovative research programs
Most countries in Europe are facing a medical demography problem as they are experiencing a shortage
of doctors in key specialities, e.g. pathology, medical oncology, surgical oncology, and radiation oncology.
Research in oncology has been demonstrated to be an extremely attractive field of research in the
last 10 years, and the EORTC is an international leader in academic clinical and translational cancer
research. The EORTC is therefore in a very good position to enable young committed researchers
to develop their careers in oncology. The scientific strategy, and dedicated initiatives in large partner
institutions, should inspire young scientists and clinicians to become the next generation of active           3
EORTC members. European and national governments, healthcare policymakers, and cancer funding
organisations will also need to be further associated with the EORTC research strategy in order
to delineate the oncology research and care of the future. The role of patient advocacy groups is
becoming more and more important, and they, too, should be associated further into our research
The EORTC has had a very successful fellowship program since 1992 and is now a full partner in
the “Flims” workshop. In recent years, the EORTC has stimulated and funded innovative research
projects of the Groups, and in 2008 awarded one million Euros for academic and clinico-genomic
research proposals. This remarkable effort should be further developed with support for the building
of applications and the calls of the seventh framework program of The European Commission, in
which the EORTC is already involved in several projects.
In my first days in the EORTC presidency, I appreciate more than ever the major importance and
responsibility that the EORTC has for the development of clinical and translational research. I would
like to express my sincere gratitude to Martine Piccart, Françoise Meunier and the EORTC Executive
Committee, Board, General Assembly, all the EORTC investigators and scientists as well as the EORTC
Headquarters staff for their support, commitment and belief in the EORTC mission. I invite all the
researchers in the centres of the EORTC Network to continue their pioneering work at a time when
the understanding of the biology of cancer and its efficient treatment seem more than ever within
our reach.
This is our mission for cancer patients.

                                                                                 Jean-Yves Blay
                                                                                 EORTC President
    Table of contents
    Foreword                                                        2
    Members of the EORTC Executive Committee 2009 - 2012            6
    The EORTC Charitable Trust Contact                              8
    European Journal of Cancer Contact                              8

    1. Structure and Organisation                                  9
    EORTC: Aims and mission                                        10
    EORTC Presidents                                               11
    EORTC Structure                                                12
    EORTC Membership                                               15
    EORTC Board 2009 - 2012: Members                               16
4   EORTC General Assembly 2009 - 2012: Members                    17
    Funding of the EORTC                                           20
    The EORTC Charitable Trust                                     22
    EORTC Headquarters                                             24
    EORTC Headquarters Staff                                       26
    EORTC Committees                                               32
          EORTC New Drug Advisory Committee (NDAC)                 33
          EORTC Translational Research Advisory Committee (TRAC)   34
          EORTC Protocol Review Committee (PRC)                    35
          EORTC Scientific Audit Committee (SAC)                   41
          EORTC Quality Assurance Committee (QAC)                  42
          EORTC Independent Data Monitoring Committee (IDMC)       43
          EORTC Membership Committee (MC)                          44
          EORTC Headquarters Institutional Review Board (IRB)      45
    EORTC Policies                                                 46
    EORTC Legal Aspects                                            48
    EORTC Scientific Strategy                                      49
    EORTC Network of Core Institutions (NOCI)                      50
    EORTC Fellowship Programme                                     51
    EORTC Involvement with the European Commission and EMEA        56
    EORTC - US National Cancer Institute (NCI) Collaboration       57
    EORTC - European Journal of Cancer (EJC) Collaboration         60
2.The EORTC Network                                                 63
EORTC Groups and Task Forces                                        64
EORTC Clinical Studies Patient Accrual                              65
EORTC Intergroup Collaboration                                      68
EORTC Affiliated Institutions and Departments                       70

3. EORTC Current Research and Strategies                            73
Where to obtain information on EORTC Open Protocols?                73
EORTC Open Protocols as of August 2009                              74
Intergroup Trials Coordinated by the EORTC as of August 2009        77
Intergroup Trials Not Coordinated by the EORTC as of August 2009    81
Reports from the EORTC Groups and Task Forces                       83
         Brain Tumour Group                                         84
         Breast Cancer Group                                        88   5
         Children’s Leukaemia Group                                 93
         Gastrointestinal Tract Cancer Group                        96
         Genito-Urinary Tract Cancer Group                         100
         Gynaecological Cancer Group                               105
         Head and Neck Cancer Group                                108
         Infectious Diseases Group                                 112
         Leukaemia Group                                           116
         Lung Cancer Group                                         120
         Lymphoma Group                                            123
         Melanoma Group                                            128
         PathoBiology Group                                        134
         Pharmacology and Molecular Mechanisms Group               139
         Quality of Life Group                                     141
         Radiation Oncology Group                                  146
         Soft Tissue and Bone Sarcoma Group                        152
         Cancer in the Elderly Task Force                          157
         Cutaneous Lymphoma Task Force                             160

4. Reports from the EORTC Headquarters                             163
5. Courses and Conferences                                         177
6. EORTC Directory                                                 179
EORTC Staff Directory                                              180
EORTC Officers Directory                                           185
    Members of the EORTC
    Executive Committee
    2009 - 2012
             EORTC President
             Jean-Yves BLAY
             Centre Léon Berard
             28, rue Laennec
             FR - 69008 Lyon, France
             Tel: +33 478 782 757
             Fax: +33 478 782 716

             EORTC Past President
             Martine PICCART
6            Institut Jules Bordet
             Bld de Waterloo, 125
             BE – 1000 Brussels, Belgium
             Tel: +32 2 541 32 06
             Fax: +32 2 538 08 58

             EORTC Vice-President
             Roger STUPP
             Centre Hospitalier Univesitaire Vaudois
             rue du Bugnon 46
             CH - 1011 Lausanne, Switzerland
             Tel: +41 21 31 40 156
             Fax: +41 21 31 40 737 // 31 40 200

             EORTC Secretary General
             Emiel RUTGERS
             The Netherlands Cancer Institute Antoni Van
             Plesmanlaan 121
             NL - 1066 CX Amsterdam, The Netherlands
             Tel: +31 20 512 25 51
             Fax: +31 20 512 25 54
EORTC Treasurer
Medical University of Gdansk
Ul. Debinki 7
PL - 80 211 Gdansk, Poland
Tel: +48 58 349 22 70
Fax: +48 58 520 38 99

EORTC Clinical Research Division Chairman
U.Z. GASTHUISBERG                                7
Herestraat 49
BE - 3000 Leuven, Belgium
Tel: +32 16 34 69 00 // 69 16
Fax: +32 16 34 69 01

EORTC Translational Research Division Chairman
Universitaetskliniken Köln
Kerpener Strasse 62
DE - 50924 Koeln, Germany
Tel: +49 221 47887743
Fax: +49 221 47886546

EORTC Director General
Françoise MEUNIER
Avenue E. Mounier 83 bte 11
BE - 1200 Brussels, Belgium
Tel: +32 2 774 16 30
Fax: +32 2 771 20 04
    The EORTC Charitable Trust
                Sir Christopher MALLABY
                Chairman of the EORTC Charitable Trust
                211 Piccadilly
                GB London W1J 9HF
                United Kingdom
                Tel: +44 20 79 17 95 71
                Fax: +44 20 74 39 02 62

                Executive Secretary: Ms Victoria Agnew

                Banking details:
8               Account number: 068-2429274-33
                Banque DEXIA
                Avenue de l’Eglise, 10B
                BE – 1150 Brussels, Belgium

    European Journal of Cancer
                John F. SMYTH
                Editor-in-Chief of the European Journal of Cancer
                The Editorial Office,
                European Journal of Cancer,
                Elsevier Science, The Boulevard,
                Langford Lane, Kidlington,
                Oxford, OX5 1 GB
                United Kingdom
                Tel: +44 (0) 1865 84 36 20
                Fax: +44 (0) 1865 84 39 77
                Administrative Editor: Ms Suzanne Peedell
1. Structure and Organisation


                                                                               EORTC Headquarters

                                                                                                          1. Structure and Organisation

The EORTC Headquarters (located in Brussels) deals with all scientific, legal and administrative issues
related to the EORTC.
Arrangements have been made for the NCI Liaison Office to be located adjacent to the EORTC
Headquarters. Moreover, the European CanCer Organisation (ECCO) formerly the “Federation of
European Cancer Societies” (FECS), the European Society for Therapeutic Radiology and Oncology
(ESTRO), the European Oncology Nursing Society (EONS), la Société Internationale d’Oncologie
Pédiatrique Europe (SIOP Europe), and the European Society of Surgical Oncology (ESSO) are also
located in the same building as the EORTC.
                                EORTC: Aims and mission
                                       Aims and mission
                                The aims of the European Organisation for Research and Treatment of Cancer (EORTC) are to
                                develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve
                                the management of cancer and related problems by increasing survival but also patient quality of
                                life. Extensive and comprehensive research in this wide field is often beyond the means of individual
                                European hospitals and can be best accomplished through the multidisciplinary multinational efforts
                                of basic scientists and clinicians.
                                The ultimate goal of the EORTC is to improve the standard of cancer treatment through the testing
                                of more effective therapeutic strategies based on drugs, surgery and/or radiotherapy that are already
                                in use and also through the development of new drugs and other innovative approaches. This is
                                accomplished mainly by conducting large, multicentre, prospective, randomised, phase III clinical
                                trials. In this way, the EORTC facilitates the passage of experimental discoveries into state-of-the-art
                                The EORTC Headquarters is based in Brussels, Belgium, from where its various activities are coordinated
       10                       and run. However, the EORTC is both multinational and multidisciplinary, and the present EORTC
                                Network comprises over 300 hospitals or cancer centres in over 30 countries, which include:
                                •   some 2,900 collaborators from all disciplines involved in cancer treatment and research;
                                •   some 5,000 new patients who are enrolled each year;
                                •   some 50 trials that are permanently open to patient entry;
                                •   some 50,000 patients who are in follow-up;
                                •   a database of more than 150,000 patients.
                                Through translational and clinical research, the EORTC offers an integrated approach to drug
                                development, drug evaluation programmes and medical practices.


                                The organisation was founded as an international organisation under Belgian law in 1962 by eminent
                                oncologists working in the main cancer research institutes of the EU countries and Switzerland. It was
                                named the Groupe Européen de Chimiothérapie Anticancéreuse (GECA) and became the European
                                Organisation for Research and Treatment of Cancer (EORTC) in 1968.
1. Structure and Organisation
EORTC Presidents

     Georges Mathé            Silvio Garattini     Dirk Willem Van Bekkum          Henri Tagnon      Lazlo George Latja
     Villejiuf, France           Milan, Italy      Rijswijk, The Netherlands     Brussels, Belgium    Manchester, UK
     (1962 - 1965)            (1965 - 1968)              (1969 - 1975)            (1975 - 1978)        (1979 - 1981)


                                                                                 Emmanuel van der
 Carl Gottfried Schmidt     Umberto Veronesi            Louis Denis                  Schueren         Gordon McVie
    Essen, Germany             Milan, Italy           Antwerp, Belgium            Leuven, belgium      London, UK
      (1981 - 1984)          (1985 - 1988)             (1988 - 1991)               (1991 - 1994)      (1994 - 1997)

   Jean-Claude Horiot      Allan T. van Oosterom
      Dijon, France           Leuven, Belgium
      (1997 - 2000)            (2000 - 2003)                                                                              1. Structure and Organisation

                                                                               Jean-Yves Blay
                                                                                Lyon, France
Alexander M.M. Eggermont
     Rotterdam, NL
                              Martine Piccart
                             Brussels, Belgium
                                                                                (2009 - 2012)
      (2003 - 2006)           (2006 - 2009)
                                EORTC Structure
                                The EORTC is comprised of the General Assembly, the Board, several committees, a network of
                                scientists and clinical investigators, and the Headquarters staff.
                                The General Assembly is the legislative body of the EORTC. Policies, proposals, and strategies are
                                discussed and approved by the General Assembly. The General Assembly delegates specific functions
                                to the Board, Committees or appointed persons.
                                The EORTC Network is organised into groups of scientists and/or clinicians each with a specific area
                                of interest in cancer research. These groups conduct translational research and/or clinical trials on
                                all types of cancers using a multidisciplinary approach. All Groups have a voting representative (the
                                Chair) within the General Assembly. In June 2005, the EORTC statutes were amended to include
                                representatives from the 15 top accruing institutions as full members of the General Assembly. The
                                General Assembly meets at least once a year and elects a new EORTC Board once every three
                                The Board is the steering and executive body, which advises the General Assembly on new activities
       12                       and formulates proposals to be ratified by the General Assembly. The Board meets at least twice a
                                year. The Board consists of 21 elected (voting) members and several ex-officio members. The voting
                                members select among themselves the President, Vice-President, Treasurer, and Secretary General.
                                The Executive Committee was created by Emmanuel van der Schueren in 1991. The Executive
                                Committee provides support to the President in the decision making and strategy planning process.
                                The Executive Committee consists of several voting members of the Board plus the Director General
                                who is an ex officio (non-voting) member of the Executive Committee. The Executive Committee
                                meets as often as needed (once every six weeks on average), and communicates via phone and e-mail
                                on a weekly basis. The Executive Committee reports to the Board.
                                The Director General coordinates all administrative, legal and financial management activities
                                of the organisation; and implements the strategies and policies as defined by the Board. Additional
                                responsibilities include EU projects coordination, information dissemination and logistic support for
                                EORTC courses and conferences.
1. Structure and Organisation
Structure of the EORTC

                                         EORTC General Assembly

                                               EORTC Board

                                Executive Committee - Director General

  Control                                                                                       Action
 Mechanisms                                                                                   Mechanisms

                                                                                 PRC                       13
MC      IRB         SAC       QAC
                                                                          NDAC         TRAC       IDMC

                                    EORTC Groups, Network of Scientists
                                         & Clinical Investigators

              Translational                                                        Clinical
                Research                  Translational Research                   Research
                Division                                                           Division

MC:     Membership Committee
IRB:    Institutional Review Committee
SAC:    Scientific Advisory Committee
QAC:    Quality Assurance Committee
                                                                                                           1. Structure and Organisation

PRC:    Protocol Review Committee
NDAC:   New Drug Development Committee
TRAC:   Translational Research Advisory Committee
IDMC:   Independent Data Monitoring Committee
                                The EORTC Network

                                All EORTC scientific activities are conducted within multidisciplinary groups divided into the
                                Translational Research and Clinical Research Divisions. Emphasis is placed on translational research
                                and cooperation between EORTC Groups and Task Forces.
                                This forms the basis of a network of oncology specialists:
                                A network of scientists:
                                • Experienced EORTC Investigators and Study Coordinators;
                                • Experienced translational research and laboratory scientists.
                                A network of institutions:
                                • A network of excellence, including the EORTC Groups, and more recently, the Network of Core
                                  Institutions (NOCI);
                                • Access to high patient accrual;
                                • Access to rare cancer subpopulations;
                                • Access to multi-tumour studies.
                                EORTC research offers an integrated approach to the evaluation of innovative agents, a comprehensive
                                broad clinical trial programme, multimodality therapeutic strategic evaluation, and special research
                                projects including the study of quality of life.
                                In cooperation with the clinical groups, the EORTC Translational Research Division focuses on pre-
                                clinical testing of new anticancer agents, receptors, and tumour markers. It also provides support
                                for translational research projects conducted within the EORTC as well as on pharmacology and
                                molecular mechanisms, pathology, and imaging.
                                The EORTC Clinical Research Division is mainly involved in the conduct of clinical trials through
                                either tumour-specific groups (Brain Tumour, Breast Cancer, Melanoma, Leukaemia, etc.) or modality-
                                oriented cooperative groups such as the Radiation Oncology Group.
                                Groups are created and dissolved by decision of the EORTC Board. The EORTC Board may set up
                                task forces, which may possibly be converted into groups after a probationary period.
                                Individuals interested in forming a Group should contact EORTC Headquarters to obtain guidance as
                                to where they would best fit into the EORTC structure.
1. Structure and Organisation
EORTC Membership
Effective Membership

All members of the General Assembly are effective members of the EORTC. In addition, members of
the EORTC Groups and EORTC Committees are associate members of the organisation.

Associate Membership

Investigators who recruit patients into EORTC clinical trials and contribute to laboratory research
conducted for these clinical studies or to other EORTC activities approved by the Board are admitted
as associate members. They must be natural persons.
Applications of candidate associate members are submitted for assessment by the Membership
Committee. They may be submitted by the candidate directly or by a Group Chair. The Membership
Committee delivers its recommendation to the Board. A Group Chair may appeal to the General              15
Assembly against the refusal of an application he or she had submitted.
Associate membership is granted for an initial probationary period ending immediately prior to
the date of the third ordinary General Assembly held after the admission of the associate member.
Associate membership can then be renewed for successive periods of three years. The Board decides
on the renewals at its last meeting before each ordinary General Assembly. A Group Chair may appeal
to the General Assembly against the refusal to renew the associate membership of a member of his
or her group.
The Board may withdraw the associate membership from members who no longer meet the
admissibility criteria applied by the Board (a minimum of 15 patients recruited over the last 3 years
across all EORTC Groups) or upon recommendation of the Quality Assurance Committee for lack
of compliance or quality.
In some circumstances, other types of membership may be considered for scientists who bring a
substantial contribution to the activities of a group without recruiting patients into clinical trials
(basic scientists, pathologists, and radiologists, etc.). Foreign membership may be considered for
“temporary” affiliation of an institution with an EORTC Group in the context of a specific clinical
trial provided that EORTC rules allowing foreign membership have been followed.
                                                                                                         1. Structure and Organisation

                            For further information regarding membership,
             please contact the EORTC Membership Committee at the following address:
                               Avenue Mounier 83/11, B-1200 Brussels,
            Additional information is also available in the ‘Membership Committee’ section.
                                EORTC Board 2009 - 2012:
                                EORTC Board 2006 - 2009:Members
                                FULL MEMBERS (VOTING)

                                President                                                J.-Y. Blay, Lyon (FR)
                                Past President                                           M. Piccart, Brussels (BE)
                                Vice-President                                           R. Stupp, Lausanne (CH)
                                Secretary General                                        E. Rutgers, Amsterdam (NL)
                                Treasurer                                                J. Jassem, Gdansk (PL)
                                Clinical Research Division (CRD)                         P. Schöffski, Leuven (BE)
                                Translational Research Division (TRD)                    N. Harbeck, Köln (DE)
                                Independent Data Monitoring Committee (IDMC)             R. Kaplan, Leeds (UK)
                                Membership Committee (MC)                                A.M.M. Eggermont, Rotterdam (NL)
                                New Drug Advisory Committee (NDAC)                       J.-C. Soria, Villejuif (FR)
       16                       Protocol Review Committee (PRC)                          F. Shepherd, Toronto (CA)
                                Quality Assurance Committee (QAC)                        K. Haustermans, Leuven (BE)
                                Scientific Audit Committee (SAC)                         I. Tannock, Toronto (CA)
                                Translational Research Advisory Committee (TRAC)         S. Sleijfer, Rotterdam (NL)
                                Member                                                   D. Fennell, Belfast (UK)
                                Member                                                   H. Gelderblom, Leiden (NL)
                                Member                                                   L. Licitra, Milano (IT)
                                Member                                                   C. Sternberg, Roma (IT)
                                Member                                                   F. Sweep, Nijmegen (NL)
                                Member                                                   E. Van Cutsem, Leuven (BE)
                                Member                                                   C. van Herpen, Nijmegen (NL)

                                EX-OFFICIO MEMBERS (NON VOTING)

                                Director General, EORTC                             F. Meunier, Brussels (BR)
                                Chairman, The EORTC Charitable Trust                Sir Christopher Mallaby, London (UK)
                                Editor-in-Chief, European Journal of Cancer         J. F. Smyth, Edinburgh (UK)
                                EJC Liaison Officer                                 J-C. Horiot, Genolier (CH)
1. Structure and Organisation

                                Executive Secretary, The EORTC Charitable Trust     V. Agnew, London (UK)
                                European Programme Manager, US-NCI Liaison Office   S. Radtke, Brussels (BE)
                                Former President                                    A.T. Van Oosterom, Leuven (BE)
EORTC General Assembly
     Gener Assembly
          al       20062009:
EORTC - 2012: Members
2009                   -   Members

Acting President                              J.-Y. Blay, Lyon (FR)

Past Presidents (last three)                  M. Piccart, Brussels (BE)
                                              A.M.M. Eggermont, Rotterdam (NL)
                                              A.T. van Oosterom, Leuven (BE)

EORTC Group Chairs

Brain Tumour Group                            W. Wick, Heidelberg (DE)
Breast Cancer Group                           T. Cufer, Golnik (SI)              17
Children’s Leukaemia Group                    Y. Benoit, Gent (BE)
Gastrointestinal Tract Cancer Group           M. Lutz, Saarbrucken (DE)
Genito-Urinary Cancer Group                   S. Osanto, Leiden (NL)
Gynaecological Cancer Group                   A. Casado-Herraez, Madrid (ES)
Head and Neck Cancer Group                    J.A. Langendijk, Groningen (NL)
Imaging Group                                 S. Stroobants, Edegem (BE)
Infectious Diseases Group                     P. Donnelly, Nijmegen (NL)
Leukaemia Group                               J.-P. Marie, Paris (FR)
Lung Cancer Group                             M. O’Brien, Sutton (UK)
Lymphoma Group                                R. van der Maazen, Nijmegen (NL)
Melanoma Group                                P. Patel, Nottingham (UK)
PathoBiology Group                            M.G. Daidone, Milano (IT)
Pharmacology and Molecular Mechanisms Group   G.J. Peters, Amsterdam (NL)
Quality of Life Group                         G. Velikova, Leeds (UK)
Radiation Oncology Group                      V. Grégoire, Brussels (BE)
Soft Tissue and Bone Sarcoma Group            P. Hohenberger, Mannheim (DE)

EORTC Task Force Chairs
                                                                                 1. Structure and Organisation

Cancer in the Elderly                         H. Wildiers, Leuven (BE)
Cutaneous Lymphoma                            M. Bagot, Creteil (FR)
                                EORTC Committee/Division Chairs

                                Clinical Research Division                                        P. Schöffski, Leuven (BE)
                                Translational Research Division                                   N. Harbeck, Köln (DE)
                                Independent Data Monitoring Committee                             R. Kaplan, Leeds (UK)
                                Membership Committee                                              AM.M. Eggermont, Rotterdam (NL)
                                New Drug Advisory Committee                                       J-C. Soria,Villejuif (FR)
                                Protocol Review Committee                                         F. Shepherd, Toronto (CA)
                                Translational Research Advisory Committee                         S. Sleijfer, Rotterdam (NL)
                                Quality Assurance Committee                                       K. Haustermans, Leuven (BE)
                                Scientific Audit Committee                                        I. Tannock, Toronto (CA)

                                Representatives from the 15 top Academic Recruiting

                                NKI - Antoni Van Leeuwenhoekziekenhuis, Amsterdam (NL)                    E. Rutgers
                                Hôpitaux Universitaires Bordet-Erasme, Brussels (BE)                      A. Awada
                                Arnhem’s Radiotherapeutisch Instituut, Arnhem & Harderwijk (NL)           R. Keus
                                Institut Gustave Roussy,Villejuif (FR)                                    F. André
                                UZ Leuven, Leuven (BE)                                                    I.Vergote
                                Radboud University Nijmegen Medical Centre, Nijmegen (NL)                 T. de Witte
                                Centre Leon Berard, Lyon (FR)                                             O. Tredan
                                UZ Rotterdam, Rotterdam (NL)                                              R. de Wit
                                Leiden University Medical Centre, Leiden (NL)                             C. van de Velde
                                Hôpital Necker-Institut Curie, Paris (FR)                                 V. Diéras
                                Institut Bergonie, Bordeaux (FR)                                          H. Bonnefoi
                                Centre Hospitalier Universitaire Vaudois, Lausanne (CH)                   R. Mirimanoff
                                Cliniques Universitaires St. Luc, Brussels (BE)                           M. Hamoir
                                Academisch Medisch Centrum, Amsterdam (NL)                                G. van Tienhoven
                                Centre Georges-François-Leclerc, Dijon (FR)                               P. Fumoleau
1. Structure and Organisation

Board Members

Vice-President                                      R. Stupp, Lausanne (CH)
Secretary General                                   E. Rutgers, Amsterdam (NL)
Treasurer                                           J. Jassem, Gdansk (PL)
Member                                              D. Fennell, Belfast (UK)
Member                                              H. Gelderblom, Leiden (NL)
Member                                              L. Licitra, Milano (IT)
Member                                              C. Sternberg, Roma (IT)
Member                                              F. Sweep, Nijmegen (NL)
Member                                              E. Van Cutsem, Leuven (BE)
Member                                              C. van Herpen, Nijmegen (NL)
Other Effective Members

Director General, EORTC                             F. Meunier, Brussels (BE)
Chair, The EORTC Charitable Trust                   Sir Christopher Mallaby, London (UK)
Editor-in-Chief, European Journal of Cancer         J. F. Smyth, Edinburgh (UK)
EJC Liaison Officer                                 J.C. Horiot, Genolier (CH)
Executive Secretary, The EORTC Charitable Trust     V. Agnew, London (UK)
European Programme Manager, US-NCI Liaison Office   S. Radtke, Brussels (BE)
Former President                                    A.T. van Oosterom, Leuven (BE)

Past Presidents (other than the last 3)

L. Denis (BE)
S. Garattini (IT)
J-C. Horiot (FR)
G. Mathe (FR)
J.G. Mc Vie (UK)
                                                                                           1. Structure and Organisation

D. van Bekkum (NL)
U.Veronesi (IT)
                                Funding of the EORTC
                                The EORTC is funded through several sources including the EORTC Charitable Trust providing a core
                                grant which is mainly supported by numerous national cancer leagues.
                                Since 1972, the US National Cancer Institute (NCI) has provided core support to EORTC Headquarters,
                                and with this support a close scientific collaboration has been maintained to promote transatlantic
                                research projects.
                                Core grants from the Fonds Cancer, FOCA (BE), and The Parthenon Trust also provide support for
                                the EORTC Headquarters staff.
                                EORTC Headquarters also receives grants allocated by BELSPO (the Belgian Federal Science Policy
                                Office) and by the Belgian National Lottery.
                                Funding for the Fellowship Programme is provided by the EORTC Charitable Trust, Fonds Cancer,
                                FOCA (BE), the Koningin Wilhelmina Fund, KWF (NL), and several leagues including La Ligue Nationale
                                contre le Cancer (FR) and the Vlaamse Liga tegen Kanker, VLK (BE).
       20                       In addition, grants for EORTC research projects are received from the European Commission under
                                the 6th and the 7th Framework Programmes.
                                The EORTC has received support for bio-banking in a prostate cancer clinical trial from the Institute
                                for the encouragement of Institut d'encouragement de la Recherche Scientifique et de l'Innovation
                                de Bruxelles (IRSIB).
                                Clinical studies evaluating new drugs for potential registration or testing innovative therapeutic agents,
                                including some educational projects, are conducted in cooperation with pharmaceutical industry
                                partners. Pharmaceutical industry sponsorship is also provided in the form of “unrestricted grants”
                                for EORTC conferences.
                                The finances of the EORTC include all accounts from the EORTC Headquarters as well as all EORTC
                                Groups and Task Forces. These accounts are consolidated as required under Belgian Law. The 2008
                                EORTC accounts were audited by Ernst & Young.

                                The Continuity Fund

                                In 2004 the EORTC Board made the decision to build a financial buffer, the Continuity Fund, to
                                temporarily compensate for transient shortfalls in core support and/or delays in the receipt of cancer
1. Structure and Organisation

                                league donations that could significantly impact on the EORTC annual budget. The EORTC Continuity
                                Fund aims to guarantee stability to the EORTC Headquarters staff.
The Academic Research Fund

Parallel to creating the Continuity Fund, the EORTC Board initiated the creation of an Academic
Research Fund which became operational in 2005. This support is intended for clinical trials of
excellence or research projects submitted to the Board after undergoing review by the Protocol
Review Committee (PRC). Selected trials are academic in nature with inadequate or no funding from
other sources. A final decision at the Board level is required based on the strategic/added value the
proposed clinical trial brings to the overall EORTC strategy.
The Board prioritises trials based on the following criteria:
- trials of “excellence”
- trials with a translational research component
- trials with the possibility and feasibility for networking
- exceptional opportunities to potentially change clinical practice and establish new standards of
In 2008, the Board allocated additional support for academic and clinico-genomic research proposals
as well as projects conducted within the Network of Core Institutions (NOCI) and for bio-banking        21

                                                                                                        1. Structure and Organisation
                                The EORTC Charitable Trust
                                Honorary President:
                                T e RChra lr s o oayrs e H .Pi cBelgium
                                 h O TC ai b uHnrrAstrid of s sr Bl u
                                  E      t T t
                                            e         d tR . n s d gf
                                H.R.H. Princess Pei n:. Hr eAtio e i m
                                Honorary Vice-President:                    Sir Ronald Grierson
                                Chair:                                      Sir Christopher Mallaby GCMG, GCVO

                                Members of the General Assembly:

                                Chair:                                      Sir Christopher Mallaby GCMG, GCVO (UK)
                                Vice-Chair:                                 Sir David Tang KBE, Hong Kong
                                Executive Secretary:                        Mrs Victoria Agnew (UK)
                                Mrs. Marianne Boel                                          Hellerup (DK)
                                Mr. Alain Camu                                              Brussels (BE)
                                Dr. Gérard Depadt                                           Lille (FR)
                                Prof. Alexander M.M. Eggermont                              Rotterdam (NL)
       22                       Dr. Jean de Gunzburg                                        London (UK)
                                Dr. A. G. J. M. Hanselaar                                   Amsterdam (NL)
                                Mrs. Elizabeth Hjorth                                       Copenhagen (DK)
                                Prof. Jean-Claude Horiot                                    Dijon (FR)
                                Ms. Kate Law                                                London (UK)
                                Mr. Marc Leland                                             Washington DC (US)
                                Mr Oscar Lewisohn                                           London (UK)
                                Mrs. Sally Lo MBE                                           Hong Kong (HK)
                                H.R.H. Prince Guillaume of Luxembourg                       Contern (LU)
                                Baroness Suzanne von Maltzahn                               London (UK)
                                Dr. Rolf Marti                                              Bern (CH)
                                Prof. J. Gordon McVie                                       Milan (IT)
                                Prof. Françoise Meunier                                     Brussels (BE)
                                Mr. Jean Louis de Montesquiou                               Paris (FR)
                                Mr Hans Neef                                                Brussels (BE)
                                Prof. Allan T. van Oosterom                                 Antwerp (BE)
                                Mr. Ole Alexander Opdalshei                                 Oslo (NO)
                                Prof. Martine Piccart                                       Brussels (BE)
                                H.E. Ambassador Marie-Thérèse Pictet- Althann               Geneva (CH)
                                Professor Dr Martin Roth                                    Dresden (DE)
1. Structure and Organisation

                                Mr. Guido Schmidt-Chiari                                    Vienna (AT)
                                Dr. Piero Serra                                             Milan (IT)
                                Prof. John Smyth                                            Edinburgh (UK)
                                Lady Solti                                                  London (UK)
                                Prof. Bengt Westermark                                      Stockholm (SE)
                                Dr. Vitor Veloso                                            Porto (PT)
                                Mr. John E.E. Whittaker CBE                                 Neuchatel (CH)
The EORTC Charitable Trust

In 1976, the EORTC Foundation was established by Royal Decree under the laws of the Kingdom of
Belgium as an international association under Belgian Law with the specific aim of obtaining funds
for the support of the activities of the EORTC, to support the structure of the organization and to
support independent academic research projects. It receives the majority of its funds from National
Cancer Charities. All the major European National Cancer Charities which support the work of
the EORTC are represented in the General Assembly, as well as the Hong Kong Cancer Fund and
distinguished lay members.
In March 2006, the EORTC Foundation changed its name to The EORTC Charitable Trust, to take
account of recent changes in Belgian Law. The aims of The EORTC Charitable Trust remain exactly
the same.
The Honorary President is H.R.H. Princess Astrid of Belgium, and the Chair is Sir Christopher Mallaby.
Sir Ronald Grierson, Past-Chair, is now the Honorary Vice-President of The EORTC Charitable
Since the EORTC operates through existing national institutions and hospitals, its financial needs are    23
modest in relation to what it is able to achieve. The financial, then economic, crises of recent months
are of a magnitude unseen for generations and are bound to have an impact on charitable giving
and philanthropy. In these extremely difficult circumstances it remains the role and the duty of the
Charitable Trust to raise funds for cancer research, and the task is doubly hard. This underlines the
vital importance of the continued support of all the National Cancer Charities, and the Charitable
Trust would like to express its thanks and appreciation for this.
During 2008, the EORTC Charitable Trust received core support for the EORTC of 1,288,567 Euros
from several European National Cancer Charities and the Hong Kong Cancer Fund: the EORTC
Charitable Trust awarded a core grant of 1,450,000 Euros to the EORTC for the year. During 2008,
the Parthenon Trust again generously allocated core support to the EORTC Headquarters. In 2008
a generous donation was received from the Schroder Family Foundation which is supporting a
Fellowship in research in an important EORTC study in Children’s Leukaemia. This Fellowship will be
named the Schroder Foundation Fellowship.
Another very positive development in 2008 was the success of the joint Liaison Office, established
in Leeds in 2007, an initiative comprising EORTC, the National Cancer Research Network and
Cancer Research UK. The Liaison Office co-ordinates strategy and communication between all three
organisations with a view towards increasing UK participation in EORTC trials. The funding for this
                                                                                                          1. Structure and Organisation

office was provided by the Louisa Lewisohn Memorial Trust, through Mr Oscar Lewisohn. The post of
Liaison Officer is being supported for a second year by the Louisa Lewisohn Memorial Trust.
The Charitable Trust did not hold a fundraising event in 2008, although much work was done in
preparation for an event in Monaco which will take place in October 2009. The Charitable Trust
applied to the Belgian authorities in autumn 2007 for renewal of its Charitable Status for the period
2008-2013, which has been received.
The annual audit for 2008 of the EORTC Charitable Trust aisbl was carried out by
                                EORTC Registered Office


                                                          EORTC Staff
1. Structure and Organisation
      Director General’s Office                                                                                            Human Resources

       EU Programme Office
                                                                                                                      Contracts, Accounting &
                                                                 Director General
                                                                                                                      Finances reporting Unit
          Education Office

                                                                                                                         Quality Systems &
       Communications Office                                                                                              Compliance Unit

   Secretary                                                                                            Director                        Secretary
                         Scientific Director
                                                                                               Methodology and Operations

                               Early Project    Project &                 Clinical Trial                      Quality                  Independent
  Medical        Fellowship                                    Statistics                      IT                        Operations       Data
                               Optimisation    Budget Dvlpt                 Process                           of Life
Department      Programme                                                                                                Department
                                                                                                                                                      EORTC Headquarters: Organisational Charts

                               Department      Department     Department Department        Department       Department                  Monitoring

           Clinical Research       Translational               Quality Control            Protocol               Project             Clinical Trial
            Physicians Unit        Research Unit                     Unit             Development Unit       Management Unit        Assistants Unit

           Pharmacovigilance                                  Data Management        Regulatory Affairs /
                 Unit                                               Unit              Intergroup Unit

1. Structure and Organisation
                                EORTC Staff
                                      Headquarters Staff
                                Director General                                     Françoise Meunier, MD, PhD, FRCP

                                Director General’s Office
                                Coordinator                                                Lily Geyoro, MA
                                Personal Assistant                                         Saïda Jinah, BA
                                Secretary                                                  Alvine Sike, BA
                                Secretaries/Receptionists                                  Sophie Hons
                                                                                           Alexia Yannopoulos

                                EU Programme Officer                                       Stéphane Lejeune, MPH

                                Education Office Coordinator                               Danielle Zimmermann
                                Communications Office
                                Medical Science Writer                                     John Bean, PhD
                                Assistant                                                  Stéphanie Vandergooten

                                Human Resources Department
                                Manager                                                    Bernard Kamp, B Econ
                                Assistants                                                 Delphine Cnockaert, B Econ
                                                                                           Nelly Gonay, M Econ
                                Office Manager                                             Michel Vanhee
                                Maintenance                                                Farha Derbal
                                                                                           Donatella Locci

                                Contract, Accounting and Finances Reporting Office
                                Accounting Supervisor                                      Ariane Jablonka, M Econ
                                Contract Manager                                           Axelle Fortun, PhD
                                Treasury Accountant                                        Kamaludin Talib, B Econ
1. Structure and Organisation

                                Accountant                                                 Christophe Bellem, B Econ
                                Accounting Assistant                                       Eva Calatayud, MA
                                Contract Assistant                                         Nadia El Medassi

                                Quality Systems & Compliance Unit
                                Head of Quality Systems - Compliance Unit                  Cindy Wyns, MSc
                                Quality and Process Manager                                Marie-Laure Couvreur, BSc
                                Quality Assurance Auditor                                  Michel Lapaige, MSc,Vet
Scientific Director                                 Denis Lacombe, MD, MSc

Executive Secretary                                 Vicky Minas

Director Operations and Methology                   Remy von Frenckell, PhD

Secretary                                           Zeina Tayah

Assistants Directors
Head of Statistics Department                       Richard Sylvester, ScD
Senior Biostatistician                              Martine Van Glabbeke, Ir, PhD
Head of Operations & Budget / Contract Department   Ann Marinus, RN
Head of Information Technology Department           Pascal Ruyskart, MSc
Head of Quality of Life Department                  Andrew Bottomley, PhD

Medical Department                                                                    27
Head of Department                                  Jocelyne Flament, MD
Quality Associate Manager                           Akos Gulyban, MSc

Clinical Research Physicians Unit
Senior Clinical Research Physician                  Sandrine Marréaud, MD, MSc
Clinical Research Physicians                        Liliana Baila, MD, MSc
                                                    Lissandra Dal Lago, MD
                                                    Matthias Karrasch, MD
                                                    Cecilia Liberatoscoli, MD
                                                    Bjorn Penninckx, MD

Pharmacovigilance Unit
Head of Unit                                        Nathalie Dubois, MSc
Associate Head of Unit                              Christine Bastin, MSc
Managers                                            Crokart Nathalie, MSc, PhD
                                                                                      1. Structure and Organisation

                                                    Marie-Pierre Gauthier, MSc, PhD
                                                    Izabella Jagiello, PhD
                                                    Sara Meloen, MSc
                                                    Thomas Valkaert, MSc
Secretary                                           Angela Geithman Van Damme

Fellowship Programme
Executive Secretary                                 Vicky Minas
                                Translational Research Unit
                                Head of Unit                                Jacqueline Hall, PhD
                                Translational Research Officer              David Jaminé, MSc

                                Early Project Optimisation Department
                                Strategic Development Officer               Anne-Sophie Govaerts, PhD

                                Project and Budget Development Department
                                Head of Department                          Ann Marinus, RN
                                Membership Coordinator                      Teodora Kirova, BSc

                                Statistics Department
                                Head of Department                          Richard Sylvester, ScD
       28                       Associate Head of Department                Laurence Collette, MSc, PhD
                                Senior Biostatisticians                     Jan Bogaerts, ScD
                                                                            Catherine Fortpied, MSc
                                                                            Stefan Suciu, PhD
                                                                            Martine Van Glabbeke, IR, PhD
                                Biostatisticians                            Corneel Coens, MSc
                                                                            Thierry Gorlia, MSc
                                                                            Hasan Baktiar, PhD
                                                                            Murielle Mauer, PhD
                                Junior Biostatisticians                     Sandra Collette, MSc
                                                                            Monia Ouali, MSc
                                Junior Biostatistician / SAS Programmer     Jérôme Rapion, MSc, DESS

                                Clinical Trial Process Department

                                Quality Control Unit
1. Structure and Organisation

                                Head of Unit                                Christine de Balincourt, Pharm
                                Process and Compliance Manager              Christine Waterkeyn, MSc
                                Clinical Research Associate                 Aurore Jacques, MSc
                                Junior Clinical Research Associate          Steve Douterlungne, MSc
Data Management Unit
Head of Unit                             Caroline Gilotay, MSc
Associate Head of Data Management Unit   Monika Devos, RN
Crosscheck Specialist                    Steven Deleu, MSc
Training & Development Manager           Joke De Wever, MSc
Lead Data Managers                       Claire Aerts,Vet
                                         Edith Bastiaens, MSc
                                         Liv Meert, MSc
                                         Bart Meulemans, MSc
                                         Larissa Polders, MSc
Senior Data Managers                     Linda De Prijck, BSc
                                         Nicole Duez, MSc
                                         Livia Giurgea, PhD
                                         Catherine Hermans
                                         Izabella Jagiello, PhD         29
                                         Marie-Ange Lentz, MSc
                                         Marianne Pierart, MSc
Data Managers                            Wilson Ashimwe, MSc
                                         Nawal Bekka, MSc
                                         Miet Celis, MSc
                                         Valery Daubie, MSc
                                         Peter De Burghgraeve, MSc
                                         Maarten De Rouck, MSc
                                         Valérie Dewaste, PhD
                                         Marlies Dictus, MSc
                                         Dorien Druyts, MSc
                                         Sven Janssen, MSc
                                         Sandrine le Polain, MSc
                                         Lies Meirlaen, MSc
                                         Sarah Morren,Vet
                                         Axelle Nzokirantevye, MSc
                                         Christine Olungu, IR
                                         Nicolas Othmezouri, MSc
                                                                        1. Structure and Organisation

                                         Daphné Rasier, MSc
                                         Tiana Raveloarivahy, BSc
                                         Françoise Rigaux, BSc
                                         Seraphine Rossi, MSc
                                         Jonathan Steuve, PhD
                                         Pascale Szternfeld, MSc
                                         Katrien Van Den Bossche, MSc
                                Data Managers (Cont'd)                 Christelle Vandermaelen, MSc
                                                                       Ellen Veyt, MSc
                                                                       Caroline Wanko, MSc
                                Administrative Assistant               Sabrina Decot
                                Data Entry Clerks                      Ilka Debruyne
                                                                       Francine De Vleeschouwer

                                Protocol Development Unit
                                Head of Unit                           Jillian Harrison, PhD
                                PRC Secretariat Officer                Gabriel Solbu, MSc
                                Protocol Help Desk Officer             Françoise Peeters

                                Regulatory Affairs / Intergroup Unit
                                Head of Unit                           Anastassia Negrouk, MSc, DEA
                                Regulatory Affairs Managers            Frédérique Hénot, PhD
                                                                       Marta Marques, MSc
                                                                       Carine Pontegnies, IR
                                Assistants                             Cristel Grimonpont
                                                                       Michele Lidarssi

                                IT Department
                                Head of Department                     Pascal Ruyskart, MSc
                                Associate Head of Department           Eric Decossaux, MSc
                                Computer Analyst                       Nicolas Corbo, BSc
                                Analyst Programmers                    Yves Dohogne, MSc
                                Computer Application Specialist        Jonathan O’Sullivan
                                System Manager                         Guillaume Migaszewski
                                                                       Gilles De Vrye, MSc
1. Structure and Organisation

                                IT Support Analyst                     Jouri Van Den Bergh

                                Quality of Life Department
                                Head of Department                     Andrew Bottomley, PhD
                                Officer                                Sarah Williams
                                Researcher                             Chantal Quinten, MSc
Quality of Life Department (Cont'd)
Translation Coordinator                      Linda Dewolf, PhD
Assistant to the Translation Coordinator     Petra Jeglikova Smith, MA
Clinical Trial Assistant                     Sheila Scott
Secretary                                    Ken Cornelissen
Administrative Assistant                     Irina Ghislain

Operations Department
Head of Department                           Marie-Anne Meeus, MD

Project Management Unit
Lead Project Managers                        Anouk Allgeier, PhD
                                             Annick De Brauwer, Ir, MSc
Project Managers                             Anita Akrapovic, BSc          31
                                             Hilde Breyssens, PhD
                                             Gaetan De Schaetzen, PhD
                                             An Demeester, MSc
                                             Kristel Engelen, P.T.
                                             Laura Gobbens, MSc
                                             Nadège Gosselin, PhD
                                             Anne Kirkpatrick, MSc
                                             Bénédicte Marchal, MSc, DEA
                                             Steven Mortier, MSc
                                             Elke Neven, PhD
                                             Michel Praet, PhD

Clinical Trial Assistants Unit
Lead Clinical Trial Assistant                Delphine Van Gorp
Clinical Trial Assistants                    Katrien Baus
                                             Sebina Shaukat
                                             Aurélia Siraut
                                                                           1. Structure and Organisation

                                             Laura Vanhemelryck
                                             Vinciane Vinckx

Independent Data Monitoring Committee Unit
Head of Unit                                 Richard Sylvester, ScD
Secretary                                    Françoise Peeters
Officer                                      Gabriel Solbu, MSc
                                EORTC Committees
                                Several EORTC committees have been created to oversee the independence of the EORTC, as well
                                as the relevance and scientific value of all research efforts, thereby ensuring the highest quality of
                                scientific work possible. Each Committee Chairman serves a three year elected term.


                                EORTC New Drug Advisory Committee (NDAC)
                                EORTC Translational Research Advisory Committee (TRAC)
                                EORTC Protocol Review Committee (PRC)
                                EORTC Scientific Audit Committee (SAC)
                                EORTC Quality Assurance Committee (QAC)
       32                       EORTC Independent Data Monitoring Committee (IDMC)
                                EORTC Membership Committee (MC)
                                EORTC Headquarters Institutional Review Board (IRB)
1. Structure and Organisation
EORTC New Drug Advisory
Committee (NDAC) Committee(NDAC)
The aim of the New Drug Advisory Committee (NDAC) is to expedite the introduction of new drugs
into clinical trials within the EORTC. It works closely with EPOD (the Early Project Optimization
Department) within EORTC Headquarters, and to a lesser extent with the Translational Research
Advisory Committee (TRAC). In order to ensure a consistent approach towards the pharmaceutical
industry, the NDAC acts as a reference body for all EORTC Groups and makes recommendations to
them in all aspects of drug development. This includes the strategic approach and setting priorities
regarding drug development within the entire EORTC Network as well as being a recipient of
information from disease groups at the earliest stages of their discussions about trials involving new
agents. It encourages early contact with investigators and disease groups.
The remit of the NDAC are those agents that have not been registered and/or not yet with a role in
oncology or possibly agents which come to the EORTC for the first time in a specific setting. Working
very closely with EPOD, NDAC’s continued mission is to stimulate, organise and prioritise access
to new drugs. It has responsibility for benchmarking the choice of target/ agent and/or company,
taking advice from both the disease specific groups and EPOD. The expectation is that the earlier the
involvement of NDAC (and of course EPOD) in the development of a project, the higher the chance
of such projects being approved by the Executive Committee as they will already be aligned with
EORTC priorities.
The NDAC coordinates Advisory Boards performed with the pharmaceutical industry, and in 2009
oversaw, along with EPOD, a very successful interaction with a large pharmaceutical company which
has led to a number of new projects being actively discussed between the EORTC and the company.
The NDAC also supports EPOD regarding methodological issues inherent to innovative agents with
new mechanisms of action in the approach of early studies design.
Along with TRAC, NDAC continues to comment on projects being reviewed by the Protocol Review
Committee, and this past year there were 35 such projects, indicating a healthy activity in the
generation of new projects within the EORTC.


Chairman                    J.-C. Soria, Villejuif (FR)
Members                     A. Awada, Brussels (BE)                K. Dhingra, Sparta (US)
                                                                                                         1. Structure and Organisation

                            U. Banerji, Sutton (UK)                M. Scurr, London (UK)
                            A. Burger, Baltimore (US)              J. Tabernero, Barcelona (ES)
                            J. Dancey, Kingston (CA)               M. van den Bent, Rotterdam (NL)
                            M. de Jonge, Rotterdam (NL)
Ex-Officio members          N. Harbeck, Köln (DE)
                            D. Lacombe, Brussels (BE)
                            S. Sleijfer, Rotterdam (NL)
                                EORTC Translational Research
                                E R Cr n l to a e e r h d i o(TRAC)e( R C
                                 O TT a sa i n R s a cA vs y o mt
                                Advisory Committee r C m i t eT A )
                                The Translational Research Advisory Committee (TRAC) was created to support and provide expert
                                advice from a scientific and practical perspective on translational research projects conducted within
                                the EORTC. The aims of the TRAC are to ensure the independence of EORTC, the relevance of
                                translational research efforts, and to guarantee scientifically sound results so as to increase the
                                scientific visibility of the EORTC. As a pre-clinical scientists advisory committee, the TRAC also acts
                                as a permanent EORTC forum between the Clinical and Translational Research Divisions by fostering
                                interest in translational research within Clinical Research Division Groups and promoting clinical
                                development ideas/concepts emerging from Translational Research Division Groups.
                                Missions of the TRAC:
                                • To lead Strategic translational research developments within the EORTC;
                                • To assist EORTC Clinical Groups in optimizing translational research studies and
                                  integrating translational research approaches into their scientific strategy;
                                • To stimulate EORTC translational research projects either as side studies of new EORTC
       34                         clinical trial protocols or on the use of existing sets of clinically annotated bio-samples;
                                • To provide expert advice on any translational research project conducted within the
                                  EORTC both from scientific and practical perspectives;
                                • To ensure optimal flow of information between EORTC Translational Research and Clinical
                                  Research Divisions and contribute to the reinforcement of the EORTC platform of
                                  pathogists and laboratory scientists;
                                • To support the Early Project Optimization Department (EPOD).
                                The TRAC comprises permanent members and ex-officio members. All the main disciplines of
                                translational research in oncology are represented in the review panel. Each member of the TRAC is
                                elected for a renewable three-year term.


                                Chair S. Sleijfer, Rotterdam (NL)
                                Vice-Chair S. Tejpar, Leuven (BE)

                                F. Cardoso, Brussels (BE)                                   M. Schmitt, München (DE)
                                M.G. Daidone, Milano (IT)                                   C. Sotiriou, Brussels (BE)
1. Structure and Organisation

                                M. Debiec-Rychter, Leuven (BE)                              S. Stroobants, Edegem (BE)
                                T. de Witte, Nijmegen (NL)                                  F. Sweep, Nijmegen (NL)
                                J. Foekens, Rotterdam (NL)                                  A. Wozniak, Leuven (BE)
                                O. Hoekstra, Amsterdam (NL)                                 N. Zaffaroni, Milano (IT)
                                R. Iggo, Fife (UK)
                                                                                            Ex-Officio Member
                                K. Kerr, Aberdeen (UK)
                                                                                            J. Hall, Brussels (BE)
                                P. Lambin, Maastricht (NL)
                                                                                            N. Harbeck, Köln (DE)
                                S. Michiels, Paris (FR)
                                                                                            J.-C. Soria, Villejuif (FR)
                                G. Peters, Amsterdam (NL)
EORTC Protocol Review
Committee (PRC)
All protocols conducted by EORTC need to be approved by an independent panel of experts. This
independent peer review process has been implemented by EORTC as early as 1983: the Protocol
Review Committee (PRC) appointed by the EORTC Board reviews all projects proposed by EORTC
For a study to be conducted under the EORTC label, EORTC experts have to have an impact on
the study design and the project has to be approved by the PRC. In addition, the database should be
handled by the Headquarters (HQ) staff and the final analysis should be performed by an EORTC
statistician unless conducted by another independent research group in the context of a so-called
intergroup clinical trial.
The PRC comprises experts in the field of cancer clinical research. All disciplines of oncology are
represented in the review panel. About 50% of the PRC members are non-EORTC, which also includes
a representative of the US National Cancer Institute (NCI) Cancer Therapy Evaluation Program
(CTEP). Additionally, the PRC makes systematic use of external reviewers – a minimum of three and a
maximum of five international experts are consulted for each outline, thereby providing independent           35
The function of the EORTC PRC is to assess the compliance of studies proposed by EORTC Groups
with the EORTC scientific strategy, and to assess their scientific value in terms of originality, interest,
methodology and scientific feasibility. The PRC assists the groups whenever necessary concerning any
aspect of the design and implementation of their studies from the first outline proposal to the full
Protocol outlines are submitted to the PRC Secretariat via the Internet using a supplementation and
maturation of the information provided in the Early Project Optimization Department (EPOD) form.
The outline submission questionnaire is available from the EORTC website: Once final,
an outline is submitted to the PRC. This can only be done after an initial feasibility go-ahead.
About 50% of the submitted protocols are joint protocols with non-EORTC Groups (e.g. MRC-CTU,
FNCLCC, GIMEMA, NCIC-CTG) and of these approximately 60% are coordinated by the EORTC.
The review of intergroup studies depends on whether the EORTC is the coordinating group or joins
a protocol which will be run by another Group’s data centre.
Outlines may be approved at the time of review or more often only approved after revision, and
others are rejected. Most protocol outlines are resubmitted after detailed comments from the PRC
and could still at that time be reviewed by external experts of the particular field involved.
                                                                                                              1. Structure and Organisation

Outlines approved by the PRC may be subsequently developed as full protocols once feasibility has
been confirmed and if the budget needed to manage the study is fully covered. If this budget is not
fully covered, they are subsequently submitted to a competitive selection process carried out by the
EORTC Board. The Board will decide to allocate EORTC funding (from the EORTC Academic Fund)
on the basis of the scientific evaluation provided by the PRC.
                                In order to simplify the writing of the full protocol, but also to guarantee homogeneity of protocols
                                and compliance to EORTC policies, the PRC in conjunction with the EORTC Protocol Help Desk have
                                developed a set of core documents and templates available to the EORTC HQ teams and Groups. The
                                PRC approved documents include guidelines to improve the content/clarity of all protocols; guidelines
                                developed for the writing of each of the chapters and appendices of a protocol and standard versions
                                for various administrative chapters (for example insurance, ethical consideration, reporting serious
                                adverse event and randomisation).
                                The Protocol Development Unit (PDU) follows the overall protocol development and approval
                                process. Full protocols must be a faithful development of approved outlines. Significant modifications
                                of the study outline after its approval will need to be approved again by the PRC. If the modifications
                                have an impact on the resources to be allocated by the EORTC, the decision of the EORTC Board
                                to have the study supported by the EORTC may be reconsidered. After a protocol is approved and
                                released any change is deemed an amendment. The PRC approves scientific amendments to EORTC
                                protocols and the PDU coordinates their implementation into protocols.
                                All efforts are made to speed up the review process to meet the wish of groups to get protocols
                                activated quickly but there is an absolute necessity for the PRC to make sure that all studies with the
       36                       EORTC label are carried out according to the highest possible standards (scientific, administrative
                                and regulatory) of clinical scientific investigation. The New Drug Advisory Committee (NDAC),
                                the Translational Research Advisory Committee (TRAC) and the Elderly Taskforce (TFE) provide
                                additional scientific expertise when needed.


                                Chair F.A. Shepherd, Toronto (CA)
                                Vice-Chair M. Eriksson, Lund (SE)
                                J.-P. Armand, Toulouse (FR)                           Phase I-II PRC Experts:
                                J. Bernier, Genolier (CH)                             J. Cassidy, Glasgow (UK)
                                S. Bodis, Aarau (CH)                                  M. De Jonge, Rotterdam (NL)
                                A. Craft, Newcastle (UK)                              H. Dumez, Leuven (BE)
                                T. de Witte, Nijmegen (NL)                            G. Eckhardt, Denver (US)
                                V. Diéras, Paris (FR)                                 H.W. Hirte, Hamilton (CA)
                                C. Dittrich, Vienna (AT)                              I.R. Judson, London (UK)
                                F. Guillemin, Vandoeuvre les Nancy (FR)               P.J. O’Dwyer, Philadelphia (US)
1. Structure and Organisation

                                C. Hill, Villejuif (FR)                               W. Parulekar, Kingston (CA)
                                N. Isambert, Dijon (FR)                               A. Ravaud, Bordeaux (FR)
                                E. Jäger, Frankfurt (DE)                              L. Seymour, Kingston (CA)
                                O.S. Nielsen, Aarhus (DK)                             L. Siu, Toronto (CA)
                                J. Oliveira, Lisboa (PT)
                                M. Parmar, London (UK)                                Ex Officio:
                                R. Rosell, Badalona (ES)                              D. Lacombe, Brussels (BE)
                                A. Sobrero, Genova (IT)                               F. Meunier, Brussels (BE)
                                G. Velikova, Leeds (UK)                               R. Sylvester, Brussels (BE)
                                C. Weltens, Leuven (BE)                               M. van Glabbeke, Brussels (BE)
Summary of the Protocol Review Committee activities
From 1 st January 2008 until 31st May 2009

24 outlines were reviewed between January 2008 and April 2009.The review of these outlines involved
more than 100 independent reviews by members of the PRC or Phase I/II experts and more than 100
independent reviews by external reviewers.
In the period ranging from beginning January 2008 to end of May 2009 (refer to table), a total of 29
new outline proposals (1 Phase I, 1 Phase I-II, 8 Phase II, 1 Phase II/III, 15 Phase III, 3 observational
studies) were submitted to the PRC. Of these, 22 were accepted, one was rejected 4 outlines remain
pending for resubmission and for 2 outlines the review is ongoing.

Outlines reviewed from 1st January 2008 until 31st May 2009

                                                                               1ST OUTlINE    lATEST
      STUDy                   GROUP(S)              PHASE       STRATEGIC
                                                                               SUbMISSION     DECISION

                                                In 2009
 21081              Cutaneous Lymphoma                III          1A+         09/10/2008
 30081              Genito-Urinary Tract Cancer      Obs          Other        08/10/2008
 21082              Cutaneous lymphoma                III          1B+         09/10/2008
 40071              Gastrointestinal Tract Cancer      II          1B+         07/07/2008
 75082-08086        Elderly + Lung Cancer              II          2B          11/03/2009
                    Radiation Oncology + Breast                                              23/04/2009
 22085-10083                                          III          2A+         02/12/2008
                    Cancer                                                                    Accepted
 90091-10093        NOCI + Breast Cancer               II          2B+         14/01/2009
                                                                                                            1. Structure and Organisation

 62082              Soft Tissue and Bone Sarcoma      III          1A+         26/02/2009
 58081              Children Leukaemia               Obs            4          16/04/2009

 10094              Breast Cancer                     III          1C          23/03/2009     Ongoing

 06083              Leukaemia                        II/III        1C          13/05/2009     Ongoing
                                                                                                           1ST OUTlINE    lATEST
                                    STUDy                  GROUP(S)               PHASE     STRATEGIC
                                                                                                           SUbMISSION     DECISION

                                                                             In 2008
                                                  Radiation Oncology +                                                   10/06/2008
                                22043-30041                                        III         1A+         09/11/2004
                                                  Genito-Urinary Tract Cancer                                             Accepted
                                62072             Soft Tissue and Bone Sarcoma     III         1A          06/07/2007
                                                  Lung Cancer + Radiation                                                04/03/2008
                                08072-22074 (M)                                    III         1A+         06/12/2007
                                                  Oncology                                                                Accepted
                                                  Brain Tumour + Radiation                                               19/03/2008
                                26071-22072                                        III         1A+         11/12/2007
                                                  Oncology                                                                Accepted
                                06071 (M)         Leukaemia                        III         1A+         16/01/2008
                                                  Brain Tumour + Radiation                                               03/03/2008
                                26081-22086 (M)                                    III         2A+         18/01/2008
       38                                         Oncology                                                                Accepted
                                                  Brain Tumour + Radiation                                               17/04/2008
                                26082-22081                                         II         2B+         31/01/2008
                                                  Oncology                                                                Accepted
                                                  Radiation Oncology + Head                                              12/09/2008
                                22071-24071                                        III         1A+         29/02/2008
                                                  and Neck Cancer                                                         Accepted
                                20081 (M)         Lymphoma                         I/II       3C+          05/03/2008
                                                  Radiation Oncology + Brain                                             25/04/2008
                                22073-26072                                        III         1A+         28/03/2008
                                                  Tumour                                                                  Resubmit
                                75081-10081       Elderly + Breast Cancer           I          2B+         21/04/2008
                                26083             Brain Tumour                      II         2B+         15/05/2008
                                08071             Lung Cancer                       II         2B+         16/07/2008
                                10085 (C)         Breast Cancer                   Obs         Other        19/09/2008
                                30073             Genito-Urinary Tract Cancer      III         1A+         19/09/2008
1. Structure and Organisation

                                                  Gastrointestinal Tract Cancer                                          26/11/2008
                                40081-22083                                         II         1B+         22/09/2008
                                                  + Radiation Oncology                                                    Accepted
                                40083             Gastrointestinal Tract Cancer     II         1B+         09/10/2008
                                18081             Melanoma                         III         1A+         21/11/2008
From the 1st January 2008 until 31st May 2009, a total of 14 Full Protocols / Group Specific Appendices
(GSAs) have submitted for review. Of those, 13 were approved; and one was in the review process at
the end of May 2009.
During the same period, 54 study amendments were approved (34 scientific and 20 administrative

Submission of outlines and protocols to the EORTC Protocol
Review Committee

For each study proposed by an EORTC Group, an outline should be submitted to the EORTC PRC
via the Internet. The outline should briefly describe and justify the principal parameters of the
trial (objectives, principal eligibility criteria, therapeutic interventions, end-points, statistical design,
companion studies and translational research projects) in such a way that the PRC will be able to
assess the scientific value of the proposed study. The outline should also identify a Study Coordinator
appointed by the EORTC Group(s), and eventual non-EORTC partners. All submitted outlines must
be approved by the EORTC Group Chairman.                                                                        39
Prior to PRC submission, the study proposal should have been approved by the EORTC Executive
Committee. EPOD will be in charge of the submission process. Groups are encouraged to discuss their
projects with EPOD prior to submitting to the EORTC Executive Committee. EPOD was established
to support the groups in streamlining their projects and strategies along the EORTC strategy defined
by the EORTC Board.
For studies that might contribute to a new drug development project, the Groups are advised to
consult the NDAC. For studies including a Translational Research project, the Groups are advised to
consult the TRAC. Eventual support of the NDAC or of the TRAC should be notified at the time of
outline submission.
An outline can only be submitted to the PRC once it has an initial budget and feasibility go-ahead from
the Project and Budget Development Department.
The first PRC decision will be notified to the EORTC Study Coordinator(s), the EORTC Group
Chairman and the EORTC HQ team within one month of receipt of the outline (approval, resubmission
or rejection).

Full Protocol Submission
                                                                                                                1. Structure and Organisation

Full protocols are developed in a modular way with the logistical support of the HQ Protocol Help
Desk (PHD) and of the HQ team. Appropriate instructions, guidelines and templates will be addressed
to the Study Coordinator by the PHD shortly after outline approval.
When the final version of the full protocol is available, the Study Coordinator in collaboration with
the HQ team should send a submission letter (or e-mail) to the PRC secretariat, which includes the
description of eventual differences between the accepted outline and the full protocol.
                                The final protocol version will be submitted to an internal revision process within the HQ, to check
                                adherence with the PRC approved outline, compliance with EORTC Policies and with EORTC Standard
                                Operating Procedures, and to detect eventual discrepancies or inconsistencies that might affect the
                                conduct and/or the management of the study. In case of major discrepancies with the original outline
                                and/or irresolvable disagreement with the internal reviewers, the protocol will be resubmitted to the
                                PRC experts.
                                All Study Coordinators need to complete a conflict of interest form, according to the EORTC Conflict
                                of Interest and Confidentiality Policy, and sign the document entitled “Tasks & responsibilities of Study
                                Coordinators”. Both documents are sent to the Study Coordinator at the time of outline approval
                                and must be signed before submission of the full protocol.

                                Intergroup Studies

                                Intergroup studies should follow the EORTC Intergroup Policy. If the trial is coordinated by an EORTC
                                Group or the EORTC HQ, the EORTC approval will be obtained through the usual submission
       40                       procedure (see above). If EORTC is neither the Coordinating Group, nor the Coordinating data
                                centre, the EORTC Group(s) should appoint an “EORTC Coordinator” who will complete an outline
                                questionnaire (even if the full protocol is already available) and send to the PRC secretariat a copy of all
                                available documentation of prior peer reviews of the project (preferable as electronic documents).
                                If the study is already active in another group, the reasons why the EORTC will join the trial at a late
                                stage should be explained in the comment section of the outline questionnaire. If the full protocol
                                is already finalized, it should be sent to the PRC secretariat at the time of outline submission. If the
                                “EORTC Group Specific Appendix” (GSA) is already finalized and approved by the EORTC Regulatory
                                Affairs and Intergroup Unit, the PRC Secretariat should be informed. Development of the full protocol
                                is normally the responsibility of the Coordinating Group. The EORTC HQ will develop an “EORTC
                                GSA”. The further review process will be decided by the PRC on the basis of the information provided
                                at the time of outline submission.


                                After PRC approval, any modifications to the protocol, PIS/IC or GSA must be discussed and
                                subsequently submitted or notified to the PRC, as appropriate.The changes will be reviewed, approved
1. Structure and Organisation

                                and implemented in the protocol, and a new version issued. The HQ will make new versions available
                                on the web site, circulate the amendment and the new version of the protocol to all investigators, and
                                will inform health authorities and ethics committees when needed.

                                      All documents and correspondence should be addressed to the EORTC PRC Secretariat
EORTC Scientific Audit
Committee (SAC)
The EORTC Scientific Audit Committee (SAC) gives independent advice to the EORTC Board
regarding the activities and scientific output as well as overall priorities and strategies of the Divisions,
Groups and Task Forces of the EORTC. Recommendations also include criteria such as conformity
with EORTC structure, policies, and interaction with other EORTC Groups.
The SAC evaluates the effectiveness of the research programmes conducted by the Groups. The
SAC provides suggestions intended to strengthen the Groups and overall functioning of the EORTC.
Each research group bearing the EORTC name is reviewed every 3 to 4 years. Approximately 50% of
SAC members have no EORTC involvement. Its members represent a cross-section of opinion and
expertise. The choice of EORTC members or non-EORTC members is approved by the Board and is
revised as appropriate.
Members are committed to a three-year renewable term. The SAC chairman reviews the composition
of SAC after his/her appointment and makes a proposal for new members to the EORTC Board. A
replacement of only two to three members at a time is recommended to avoid a lack of continuity
in SAC reviews.                                                                                                 41

Members & Ex-Officio Members

Chair               I. Tannock, Toronto (CA)
Secretary           F. Cardoso, Brussels (BE)
D. Bron, Brussels (BE)
J. Celis, Copenhagen (DK)
C. Dittrich, Vienna (AT)
E. Eisenhauer, Ontario (CA)
K. Ang, Houston (US)
F. Meunier, Brussels (BE)
L. Paz-Ares, Sevilla (ES)
M. Tempero, San Francisco (US)
C. Van De Velde, Leiden (NL)
M. Verheij, Amsterdam (NL)                                                                                      1. Structure and Organisation

Scientific Audit Committee Report 2009

In 2008 and 2009, eight Groups were reviewed: Cancer in the Elderly Task Force, Pharmacology and
Molecular Mechanisms, Gastrointestinal Tract Cancer, Children’s Leukaemia, Leukaemia, Lung Cancer,
Brain Tumour, and Pathobiology Groups.
Simultaneously SAC also reviewed the acceptance of previously audited groups and discussed their
answers to questions or missing points as well as their compliance or first actions to implement
Board approved SAC recommendations.
                                EORTC Quality Assurance
                                EORTCQuality (QAC) Committee(QAC)
                                The primary objective of the EORTC Quality Assurance Committee is to work closely with all quality
                                assurance partners from the disease oriented groups and the EORTC Headquarters Quality Systems
                                & Compliance Unit (QS&C) to ensure continuous improvement and development of forward thinking
                                in relation to quality strategies. The QAC will assess serious non-compliance issues and recommend
                                actions, as appropriate, to comply with Good Clinical Practice and new directives/guidelines from
                                Regulatory Authorities.For issues in which an allegation of scientific misconduct has been raised, the
                                issues are directed to the QAC, and the follow up is coordinated by the QS&C and the QAC. The
                                QAC ensures that appropriate actions are put in place in collaboration with the QS&C unit.
                                The QAC reports these issues to the EORTC Board.


       42                       Chair K. Haustermans, Leuven (BE)
                                Secretary C. Wyns, Brussels (BE)
                                L. Collette, Brussels (BE)
                                M. den Dulk, Nijmegen (NL)
                                L. Greillier, Marseille (FR)
                                M. Leahy, Manchester (UK)
                                F. Meunier, Brussels (BE)
                                P. Poortmans, Tilburg (NL)
                                H. van Krieken, Nijmegen (NL)
1. Structure and Organisation
EORTC Independent Data
E R Cn e e d nD t M nt rn C(IDMC)D C
 O T I d p n e t a a o i o i g m i t eI
Monitoring Committee o mt e ( M )
A permanent Independent Data Monitoring Committee (IDMC) was established in 2001 to review
the status of EORTC clinical trials and make recommendations to the Groups concerning trial
continuation, modification and/or publication.


Chair R. Kaplan, Leeds (UK)
A. Awada, Brussels (BE)
F. Lejeune, Lausanne (CH)
B. Littbrand, Umea (SE)
G. Griffiths, Cardiff (UK)
K. Pritchard, Toronto (CA)
P. Scalliet, Brussels (BE)                                                                             43
S. Stenning, London (UK)
R. Sylvester, Brussels (BE) (Ex-officio member)
In accordance with EORTC POL 004, external study specific experts provide advice to the committee
on a confidential basis.
The committee meets on a quarterly basis or according to need. In 2008, six different trials were
IDMC review is mandatory for phase III trials where formal interim analyses and early stopping rules
are foreseen and is recommended in the following situations:
• Intergroup trials coordinated by the EORTC
• All trials requiring the randomization of more than 1000 patients or more than four years
  of patient accrual
• Trials with highly toxic regimens or particular safety concerns
• Trials encountering major strategic dilemmas (for instance, problematic issues arising from
  similar studies elsewhere)
• Pivotal phase III trials which will be used for drug registration.
• Randomized phase II trials that may be continued as a phase III trial without clear rules in
  the protocol.
                                                                                                       1. Structure and Organisation

The IDMC also reviews requests for the early release of data prior to trial maturity.
The Committee’s recommendations are forwarded to the trial management group and to the EORTC
Executive Committee when further action is required.

             A general EORTC policy for IDMCs and interim analyses has been established
                   and is available on the EORTC website at the following address:
                                EORTC Membership Committee
                                EORTC Membership Committee (MC)
                                The Membership Committee (MC) was created and approved by the Board in November 2004.
                                Since then, EORTC membership has been subject to a ‘location criterion’ restricting membership
                                to ‘geographical Europe’ due to administrative and logistical complexity. However, centres from
                                Mediterranean countries (e.g. Turkey, Israel and Egypt) which had been members of the EORTC
                                before the ‘location criterion’ was introduced may continue to be members of the EORTC under
                                condition that they perform and provide support for any administrative, regulatory and logistical
                                organization to EORTC Headquarters.
                                However, new institutions located outside ‘geographical Europe’ which are not members of the
                                EORTC are invited to collaborate in so-called ‘EORTC Intergroup studies’ (See EORTC POL 005).
                                Intergroup studies are decided on a case by case basis according to the capabilities of the potentially
                                collaborating groups, i.e., whether these groups contribute sufficiently to the studies by engaging a
                                large number of centres with a significant number of patients.

       44                       Members

                                Chair A.M.M. Eggermont, Rotterdam (NL)
                                Secretary A. Marinus, Brussels (BE)
                                T. Conroy, Vandoeuvre les Nancy (FR)
                                T. de Witte, Nijmegen (NL)
                                J.W. Leer, Nijmegen (NL)
                                F. Meunier, Brussels (BE)
                                R. Mirimanoff, Lausanne (CH)
                                J. Vermorken, Edegem (BE)
                                New membership in the EORTC is organized in a centralized procedure:
                                any new applicant (institution / member) must submit a membership application to the Membership
                                Committee. The Membership Committee assesses the application in question according to the
                                following criteria:
                                •   track record of research of the institution / member;
                                •   status of available medical facilities of the institution / member;
                                •   availability of qualified personnel for clinical trial management of the institution / member;
1. Structure and Organisation

                                •   the potential benefit for other EORTC institutions / members that the applying institution /
                                    member might provide.
                                Lastly, the Board grants membership on the basis of a report issued by the Membership Committee
                                in collaboration with the EORTC Chairs of the relevant EORTC Groups.

                                     For further information regarding membership, please contact the EORTC Membership Committee
EORTC Headquarters
EOR Da Center Review Board (IRB)
   TC ta                 Re w      d
InstitutionalInstitutional vie Boar (IRB)
The Institutional Review Board (IRB) of the EORTC Headquarters is responsible for safeguarding the
rights and welfare of subjects participating in clinical trials supported by the Headquarters. In particular,
the IRB is responsible for protecting the privacy and confidentiality of the individuals’ data. The IRB is
responsible for the validation of the document templates for informed consent and patient information
sheets. All institutions and investigators submitting data to the Headquarters agree to abide by the
decisions of the IRB regarding data collection, transfer, storage, release, retention, and disposition, as
these pertain to individual patient privacy and confidentiality. The IRB also reviews potential conflicts
of interest reported to the Headquarters. All electronic and computer programmes/software and
procedures are evaluated annually in order to comply with the international requirements for patient
data protection.
In addition, the EORTC IRB oversees the clinical trials performed with the US cooperative groups /
national cancer institutes under the Federal Wide Agreement (FWA).

Members                                                                                                         45

Chair D. Lacombe, Brussels (BE)
F. Crawley, Leuven (BE)
H. Nys, Leuven (BE)
A. Negrouk, Brussels (BE)
J. Otten, Brussels (BE)
J.-C. Pector, Brussels (BE)
P. Ruyskart, Brussels (BE)
S. Suciu, Brussels (BE)
R. Sylvester, Brussels (BE)

                                                                                                                1. Structure and Organisation
                                EORTC Policies
                                The full text of all EORTC Policies is available on the website in the policies section.

                                • Conflict of Interest - Confidentiality
                                Defines areas of conflict of interest and identifies when disclosure should be provided (to eventually place
                                limitations on investigators’ participation in EORTC activities).

                                • Protection of human subjects participating in medical research
                                Ensures the respect of the rights and the integrity of human subjects participating in EORTC trials.

                                • Trial Misconduct and Fraud
                                Minimizes the effects of clinical trial fraud and misconduct and if possible prevents them from occurring.

                                • Independent Data Monitoring Committee and Interim Analyses
                                Describes the EORTC policy for the use of IDMC in randomized phase II and randomized phase III clinical
                                • Intergroup trials involving non-EORTC group
                                Outlines the EORTC policy on intergroup trials in order to facilitate intergroup collaboration.

                                • Criteria and guidelines for giving the EORTC label to scientific meetings

                                • Scientific Audit Committee

                                • Release of data from EORTC studies for use in External Research Projects
                                Defines the terms and conditions under which individual data from all or a subset of the patients treated
                                within EORTC protocols may be released to academic institutions for the purpose of scientific research

                                • Disclosure of Results and Publication Policy
                                Describes the EORTC policy regarding the primary trial publication with respect to the timing of the release
                                of results and publication in a peer-reviewed journal, the authorship rules, the rules for acknowledging
                                contributors to the study and sources of funding, and the review process within EORTC Headquarters.

                                • Accrual accounting in Intergroup Trials
                                Describes how patient accrual within Intergroup trials involving an EORTC clinical group will be counted
1. Structure and Organisation

                                towards EORTC membership.

                                • EORTC Support to Intergroup Trials
                                Concerns only trials not conducted by industry and describes the framework of the EORTC support to
                                Intergroup trials.

                                • New Drug Advisory Committee (NDAC)
                                Committee which supports and gives recommendations to the clinical research groups in new drug
                                development within the EORTC Network.
• Translational Research Advisory Committee (TRAC)
Committee which supports and provides expert advice on all TR projects.

• EORTC Tissue Research Policy
Outlines the general principles of EORTC Tissue research, aims of the EORTC Tumour Bank to support
histology review and translational research, and rules on material use for histology review and translational

• EORTC protocol submission, selection and development procedures
Describes the procedure implemented by the EORTC Board to select studies that will be supported by the

• Histology review process and/or biological material collection within EORTC clinical
Describes the functioning and workflow of histology review and/or biological material collection within the
scope of an EORTC clinical trial.

• EORTC principles for investigational sites activation                                                         47
Describes the principles for investigational site participation in EORTC studies.

• EORTC Guidelines on Cancer Care
EORTC Policy for Producing EORTC Guidelines/Expert Opinions/Promotional Material on Cancer Care.

                                                                                                                1. Structure and Organisation
                                EORTC Legal Aspects
                                The EORTC is an international association under Belgian law. The registered office of the EORTC is
                                at 83, Av. E. Mounier, B-1200 Brussels, Belgium.
                                EORTC is the legal sponsor for the majority of the trials run under its auspices, except in US, Canada
                                and Australia where trials are performed in collaboration with other partners.
                                The EORTC insurance programme, established in 1993 covers all patients entered into EORTC
                                studies and for which the EORTC is the sponsor/ promoter.
                                 For Intergroup trials led by non-EORTC groups, sponsorship issue is discussed on a case by case basis
                                taking into account applicable legislation.
                                In order to fulfil the sponsor’s legal obligations and to guarantee compliance with applicable national
                                laws, the Regulatory Affairs Unit at the EORTC Headquarters keeps its legal expertise up to date in
                                more than 30 countries in Europe and other countries.
                                The EORTC also plays a major role both at the European and national levels to alert regulators to the
       48                       need for independent clinical research conducted without commercial aims.

                                Ethical Aspects and Informed Consent/Insurance

                                All EORTC protocols are written and conducted in accordance with international standards for
                                ethics: the Declaration of Helsinki, Good Clinical Practice guidelines approved by the International
                                Conference on Harmonization. A standard chapter on Ethical Considerations is included in all EORTC
                                In accordance with local, regional, and national requirements, written approval from competent ethics
                                committees must be obtained before an institution is given the authorisation to register or randomise
                                a patient into a study. Standard guidelines for obtaining informed consent from patients entered in
                                EORTC protocols have been developed. Investigators must obtain a dated and signed consent form
                                from each patient.
                                All internal and external people involved in clinical activities need to comply with EORTC policies
                                and procedures. More specifically, investigators and Board members must sign a conflict of interest
1. Structure and Organisation
EORTC Scientific Strategy
Although development of new and innovative therapies is critical for improving cancer care, the
primary interests of the EORTC remain with clinical trials that investigate strategic therapeutic
questions that will influence medical practice or will fundamentally improve the understanding of a
The EORTC has built an important part of its success on the multidisciplinary approach to cancer
treatment, and this remains the principal strength of the EORTC. However, the present-day
multidisciplinary approach to research into cancers and their treatment in the clinic also encompasses
pathologists and laboratory scientists through translational research programmes that must be
integrated into clinical trials. Hence translational research is an essential component of the EORTC
Scientific Strategy, and it contributes to the ability to distinguish between a ‘simple’ trial and high
quality academically driven studies.

Clinical Trials
The EORTC Scientific Strategy is defined by the EORTC Board and encompasses the following types
of clinical trials:
• Large phase III academic trials aimed at changing the standard of care;
• Clinical trials with a strong and methodologically sound translational research component;
• Prospective clinico-genomic trials;

• Clinical trials addressing rare tumour types.

For the EORTC Executive Committee to determine the level of importance of each new trial proposal
within the global strategy of the EORTC, for the EORTC Board to assign priorities when there is a
competitive process for resources and/or funding, and for the EORTC Scientific Audit Committee
(SAC) to review the global performance of each EORTC Group, three main trial categories have been
defined within the priorities of the EORTC. Category 1A represents the highest priority for EORTC
involvement and category 3C the lowest. The categories are defined as follows:
1A       Randomised Phase III (new standard of care)
1B       Randomised Phase III or II/III (strong targeted translational research)
1C       Intergroup type 1A or 1B (EORTC not leading)
                                                                                                          1. Structure and Organisation

2        Phase I and Phase II (novel mechanism of action plus vertical development with EORTC)
3A       Randomised Phase III or II/III (not type 1 or 2)
3B       Phase I and Phase II (novel mechanism of action but no development plan with EORTC)
3C       Phase I and Phase II (not type 2 or 3B)
                                EORTC Network of Core
                                Institutions (NOCI)
                                The EORTC Board has launched the Network of Core Institutions (NOCI) to promote and support
                                high quality translational research-driven clinical trials and to promote cooperation between the
                                Translational Research and the Clinical Research Divisions as well as among various disease oriented
                                The principal goal of NOCI is to conduct the most challenging clinico-genomic studies and transfer
                                discoveries of molecular markers and genomic signatures to new medicines and tailored therapies.
                                NOCI is a concept that optimises and builds on the strengths and expertise of the traditional disease-
                                oriented Groups as well as of the EORTC laboratory network. NOCI allows optimisation of the
                                scientific contribution of EORTC Groups while enhancing the knowledge and the know-how to build
                                sophisticated clinical trial platforms.
                                The expected benefits of the NOCI concept are multifold:
                                - NOCI offers a unique and single EORTC platform to address specific pathways and targets across
       50                       tumour types. It ensures a comprehensive approach of a certain target with multiple therapeutic
                                applications. Multiple clinical trials addressing the same target and same agents as well as single clinical
                                trials addressing the same target across tumour types are possible;
                                - NOCI ensures that laboratory expertise is delivered consistently to all disease-oriented Groups for
                                the integration of prospective high quality translational research programmes;
                                - NOCI facilitates prospective tissue collection with the final objective being the establishment of
                                bio-banks and the collection of samples on a routine basis. NOCI is therefore a key feature to
                                retrospectively address emerging challenges with access to comprehensive clinical databases and
                                related biological data.
                                NOCI consists of a network of institutions brought together for their potential to provide the
                                EORTC with a pan-European comprehensive laboratory / imaging infrastructure as well as accrual of
                                patients and will fulfil this purpose for any initiative requiring such expertise. NOCI as a concept is
                                applicable throughout the EORTC Group networks which actually constitute and benefit from the
                                expertise of NOCI.
                                The EORTC institutions have been invited to sign a specific consortium agreement which regulates
                                storage and access of biological material collected within the scope of EORTC trials. This is justified
                                by the current regulatory environment and is put in place to facilitate and promote access to such
                                biological materials for future scientific projects.
1. Structure and Organisation

                                The NOCI Steering Committee is led by Martine Piccart, EORTC past President.
EORTC Fellowship Programme


                              EORTC Fellows
                              (from left to right)
     Paul Fenton, Agnes Czimbalmos, Francesca Martinelli, Gloria Tridello,
        Gustavo Werutsky, Monia Ouali, Leen Verleye, John Maringwa
                                                                             1. Structure and Organisation
                                An EORTC Fellowship Programme was established in 1991 to promote European clinical research
                                by encouraging physicians and scientists from all over the world to stay for up to 3 years as research
                                fellows at the EORTC Headquarters in Brussels. Medical doctors, bio-statisticians, and other scientists
                                are entitled to this fellowship programme which is specifically linked to the EORTC Groups, research
                                programme or specific research projects undertaken by the EORTC Headquarters.
                                The purpose of the fellowship programme is to provide training in the methodology of clinical
                                research for physicians and other professionals interested in cancer clinical research to complete a
                                research project and/or PhD thesis based on data available in the EORTC databases. All research work
                                undertaken is performed internationally. This approach also promotes the rapid diffusion of results
                                of clinical trials.
                                Scientific support and supervision is provided by the EORTC Headquarters staff and members of
                                EORTC disease/speciality-oriented Groups.
                                Funding for the Fellowship Programme is provided by the EORTC Charitable Trust, Fonds Cancer,
                                FOCA (BE), the Koningin Wilhelmina Fund, KWF (NL), and several leagues including La Ligue Nationale
                                contre le Cancer (FR) and the Vlaamse Liga tegen Kanker, VKL (BE).
       52                       At the EORTC Headquarters, research fellowships have been awarded to 109 fellows from various
                                countries within the European Union as well as from Argentina, Australia, Brazil, Canada, Morocco,
                                Japan, the Republic of South Korea, Zimbabwe as well as from Central and Eastern Europe.
                                The Emmanuel van der Schueren Fellowship was created in 1999 in the memory of Professor Emmanuel
                                van der Schueren. This fellowship aims to promote research on quality assurance in radiotherapy.
                                The first Emmanuel van der Schueren Fellowship was awarded in 2001 and was jointly supported
                                for one year by the ‘Vlaamse Liga tegen Kanker’, FECS (ECCO), ESTRO and EORTC. Currently, this
                                programme is supported by the Vlaamse Liga tegen Kanker and the EORTC.
1. Structure and Organisation
The EORTC Headquarters Fellowship Programme
1991 – 2010

Pascal Piedbois, MD                France          1991
Peter Clahsen, MD               Netherlands     1992 - 1994
Ann Marie Ptaszynski, MD           Belgium      1992 - 1994
Sabrina Pocceschi, Lawyer            Italy      1992 - 1996
Patrick Therasse, MD               Belgium      1993 - 1995
Magdalena Bielska-Lasota, MD        Poland      1993 - 1994
Saïd Serbouti, MSc                 France       1993 - 1994
Ivana Teodorovic, MD             Yugoslavia     1993 - 1993
Adam Pawinski, MD                   Poland      1993 - 1995
Cristina Oliva, MD                   Italy      1993 - 1994
Anne Magotteaux, MD                Belgium      1993 - 1994
Denis Lacombe, MD                  France       1993 - 1996
Guido Hoctin-Boes, MD,MSc          Belgium      1993 - 1995
Koen Torfs, MSc                    Belgium      1993 - 1993   53
Elke Bahner, MD                   Germany       1993 - 1994
Desmond Curran, MSc                Ireland      1993 - 1997
Chrisa Tsitsa, MSc                 Greece       1993 - 1994
Stephan Tomasovic, Pharm           Belgium      1994 - 1995
Eugenio Zabala, PhD                  Spain      1994 - 1995
Channa Debruyne, MD                Belgium      1994 - 1997
Niels Neymark, MSc                Denmark       1994 - 1997
Thierry Gil, MD                     France      1994 - 1996
Hamdy Adham, MD                    Belgium      1994 - 1995
Joszef Horti, MD                   Hungary      1994 - 1996
Thierry Pignon, MD                  France      1995 - 1995
Tracey Cooke, RN               United Kingdom   1995 - 1996
Susan Keating, MD              United Kingdom   1995 - 1999
Laurence Collette, MSc             Belgium      1995 - 1998
Eugenio Donato di Paola, MD          Italy      1995 - 2000
                                                1995 - 1996
Francesco Pignatti, MD              Italy
                                                1997 - 1998
Henk-Jan van Slooten, MD        Netherlands     1995 - 1996
Petra J. Timmers, MD            Netherlands     1995 - 1997
                                                              1. Structure and Organisation

Jan Bussels, MSc                   Belgium      1995 - 1997
Michèle van der Heyden, MSc        Belgium      1995 - 1998
Sandra Kalman                     Australia     1996 - 1997
Debora Goran, RGN, BSc.Hons.   United Kingdom   1996 - 1998
Ingvar Rosendahl, MSc              Sweden       1996 - 1997
Gabriele Calaminus, MD            Germany       1996 - 1997
Ines Adriaenssen                   Belgium      1996 - 1999
Josée-Anne Roy, MD                 Canada       1996 - 1997
                                Sibel Ascioglu Akhan, MD                 Turkey       1996 - 1997
                                Sabine Steimle, MA                     Germany        1997 - 1999
                                Simon Cleall, MSc                   United Kingdom    1997 - 1998
                                Maryam Bigdeli, Pharm. MPH              Belgium       1997 - 1998
                                Lisa Tyndall                           Australia      1997 - 2000
                                Benoît Baron, MSc                       Belgium       1997 - 1998
                                Pieter Clahsen, MD                  The Netherlands   1998 - 1998
                                Helena Wagenaar, MD                 The Netherlands   1998 - 2000
                                Anastasia Anastasopoulou, MSc           Greece        1998 - 1999
                                Susan Caleo, Grad.Dip.Sc (Pharm.)      Australia      1998 - 1999
                                Ioannis Lainas, MSc, Pharm.             Greece        1998 - 1999
                                Sofie Van Impe                          Belgium       1998 - 2001
                                Catherine Legrand, MSc                  Belgium       1998 - 1999
                                Kristel Van Steen, MSc                  Belgium       1998 - 1999
                                Conny den Hertog-Vrieling, MD       The Netherland    1999 - 1999
                                Jocelyn Kramer, MD                  United Kingdom    1999 - 2000
       54                       Elizabeth Gray                         Australia      1999 - 2002
                                Catherine Mary Roche, MA                 Ireland      1999 - 2000
                                Jos van der Hage, MD                  Netherlands     1999 - 2000
                                Dritan Bejko, MD, MSc                   Albania       1999 - 2000
                                Alfredo Zurlo, MD                          Italy      1999 - 2000
                                Thomas Roy, MSc                          France       1999 - 2001
                                Florence Duffaud, MD                     France       1999 - 2000
                                Sandrine Marreaud, MD                    France       1999 - 1999
                                Griet Boon, MSc                         Belgium       1999 - 2001
                                Nina Bijker, MD                     The Netherlands   1999 - 2000
                                Peggy Hugo, MD                          Belgium       2000 - 2001
                                Heidy Van Wijk, MD                  The Netherlands   2000 - 2001
                                Xavier Paoletti, MSc                     France       2000 - 2001
                                Liliana Baila, MD                       Romania       2000 - 2001
                                Marlies Landheer, MD                The Netherlands   2000 - 2001
                                Natasa Djurasinovic, MD                Yugoslavia     2000 - 2002
                                Gary Stephen Collins, MSc           United Kingdom    2000 - 2002
                                Vassilios Kouloulias, MD                Greece        2001 - 2002
                                Mirella Nijmeijer, MD               The Netherlands   2001 - 2002
                                Fabio Efficace, PhD                        Italy      2001 - 2005
1. Structure and Organisation

                                Lotte Moser, MD                     The Netherlands   2002 - 2003
                                Fatma Ataman, MD                         Turkey       2002 - 2004
                                Koen Peeters, MD                    The Netherlands   2002 - 2004
                                Jeremie Lebrec, MSc                      France       2002 - 2002
                                Elçin Ozalp, MD                          Turkey       2003 - 2003
                                Iske Florien Van Luijk, MD          The Netherlands   2003 - 2004
                                Saidi Abdessamad, PhD                  Morroco        2003 - 2003
                                Takuhiro Yamaguchi, PhD                   Japan       2003 - 2004
Julie Francart, MSc                     Belgium        2004   -   2006
Sylviane Carbonnelle, MD                Belgium        2004   -   2005
Elena Musat, MD                         Romania        2004   -   2006
Hwan-Jung Yun, MD                  Republic of Korea   2005   -   2007
Maria Karina, MD                        Greece         2005   -   2006
Gaston Demonty, MD                     Argentina       2005   -   2006
Murielle Mauer, PhD                     Belgium        2006   -   2007
Alexandra dos Santos Zimmer, MD          Brazil        2006   -   2008
Diane Van Vyve                          Belgium        2006   -   2008
Tom Budiharto, MD                       Belgium        2006   -   2007
Sandra Collette, MSc                     France        2007   -   2007
Carolina Claassens, MSc            The Netherlands     2007   -   2009
Monia Ouali, MSc                         France        2007   -   2009
Leen Verleye, MD                        Belgium        2007   -   2010
Laurent Greillier, MD                    France        2007   -   2008
Oscar Matzinger, MD                   Switzerland      2008   -   2009
Francesca Bianca Martinelli, MSc          Italy        2008   -   2010   55
Athanasios Pallis, MD                   Greece         2008   -   2009
John Maringwa, MSC                     Zimbabwe        2008   -   2009
Gustavo Werutsky, MD                     Brazil        2008   -   2010
Gloria Tridello, MSc                      Italy        2009   -   2010
Agnes Czimbalmos, MD                    Hungary        2009   -   2010
Paul Fenton, MD                     United Kingdom     2009   -   2010
Jurgen Vercauteren, MSc                 Belgium        2009   -   2010
Caroline Piette, MD                     Belgium        2009   -   2010

The EORTC Lady Grierson Research Fellowship Programme

Ingvar Rosendahl, BA                   Sweden          1996 - 1997
Jocelyn Kramer, MD                 United Kingdom      1999 - 2000
Fabio Efficace, PHD                     Italy          2001 - 2002

The Emmanuel Van Der Schueren Fellowship Programme                       1. Structure and Organisation

Vassilios Kouloulias, MD, PhD          Greece          2001   -   2002
Fatma Ataman, MD                       Turkey          2002   -   2004
Elena Musat, MD                       Romania          2004   -   2005
Tom Budiharto, MD                      Belgium         2006   -   2007
Oscar Matzinger, MD                  Switzerland       2008   -   2009
Paul Fenton, MD                    United Kingdom      2009   -   2010
                                EORTC Involvement with the
                                E R C v l e e t ihhE r p a C m i so a dM A
                                 O TI ov m Commission ms nn E E
                                European nwt t eu o e noand iEMEA
                                Core support is in oncology to pursue a European-wide effort to establish state-of-the art treatment
                                strategies on an independent basis. The coordinating structure of the EORTC is conducting high-
                                quality cancer clinical research in Europe. As such, the EORTC deserves recognition and European
                                The EORTC does not receive any core support from the European Union.
                                The EORTC has a long-standing history of participation in European Commission (EC) funded projects.
                                Since 1985, the EORTC has participated in more than 25 EU research projects in various cancer
                                related fields including quality of life assessment, leukaemia research, supportive care, telematics,
                                biological response modifiers, pharmacokinetics, treatment costs evaluation, meta-analyses of cancer
                                clinical studies, biomarkers, genomic, tissues banking, fellowships and research infrastructures.
                                The EORTC created the EU Programme Office (EUPO) in 2006 with the mission to support the
                                preparation of proposals for EU projects and to coordinate and support EORTC participation in EU
                                funded projects.
                                The EORTC participation in FP6 and FP7 extends to different types of projects such as the FP6
                                TRANSBIG [Translating molecular knowledge into early breast cancer management building on the
                                BIG (Breast International Group) network for improved treatment tailoring]. The objective of the
                                project is the validation of a genomic signature to profile early breast cancer patients and then
                                adapt the treatment accordingly. The clinical trial conducted to validate the signature, EORTC 10041
                                MINDACT, is managed by the EORTC. The EORTC also participates in the FP6 CHEMORES project
                                (Molecular mechanisms underlying chemotherapy resistance, therapeutic escape, efficacy and toxicity).
                                The EORTC is an associated partner of the FP6 CONTICANET project (Connective tissue cancer
                                Participation in FP7 involves the ECRIN-PPI (European Clinical Research Infrastructures network),
                                FP7 ICREL (Impact in clinical research of European legislation); FP7 EuroCancerComs (Establishing an
                                efficient network for cancer communication in Europe) and the Innovative Medicine Initiative (IMI)
                                project PharmaTrain (Pharmaceutical Medicine Training Programmes). The EORTC is participating in
                                the BBMRI project (Biobanking and Biomolecular Resources Research Infrastructure: preparation
                                phase for the infrastructure) as an associated organisation.
                                The EORTC also works in close collaboration with the European Medicines Agency (EMEA). The
                                EORTC/EMEA collaboration focuses on improving the legislation related to drug development through
                                revising the guidelines for anticancer therapy drug development. Some EORTC biostatisticians serve
1. Structure and Organisation

                                as statistical reviewers at EMEA/CHMP.
                                The European Directive 2001/20/EC on Clinical trials was implemented in 2004 by the Member States.
                                Since the development of this new directive, the EORTC has been interacting with both European and
                                national authorities to address specific issues related to the implementation of the Directive in the
                                context of non-commercial research. Discussions on how to preserve academic clinical research and
                                the leadership role of Europeans in clinical research particularly for cancer are currently ongoing.
EORTC - US National Cancer
E R C S A i(NCI)cCollaboration o a i n
 O T - N t n l a rn tt t ( C ) ol b
Institute o aC n e I s i u eN IC la r to
The National Cancer Institute (NCI) is the leading US agency for cancer research and treatment in
the United States and is part of the National Institutes of Health (NIH). The NCI was established
by the US Congress in 1937 and its programs were intensified in 1971 after passage of the National
Cancer Act. The vast majority of NCI funds (80%) goes to grants and contracts to universities, medical
schools, cancer centers, research laboratories and private firms. The NCI supports scientists all over
the world in a broad spectrum of research activities.

European-NCI Collaborative Activities

A history of more than three decades of coordinated cancer treatment research between the
EORTC and the NCI has brought great opportunities for more efficient development of new cancer
As part of the NCI’s global strategy, the NCI Liaison Office in Brussels was created in 1972, to search     57
for potential new anticancer substances from European sources. The Office expanded quickly and has
been pivotal in moving Europe and North America closer to a common linked network.
A European Collaborative Program initiated with the EORTC in the early 70’s continues to be highly
successful in promoting the exchange of information on new drugs for both pre-clinical and clinical
evaluation. The compound acquisition, selection, screening, formulation, toxicology, and the clinical
evaluation are now well integrated between Europe and the USA. Much of this success in new drug
development has been facilitated by the close working relationship between the NCI, the EORTC, and
the British Cancer Research United Kingdom (CRUK) in London.

European Collaborative Agreements

Collaborative Agreements signed between the NCI and the EORTC, CRUK, and the Southern
Europe New Drugs Organization (SENDO) in Italy define the role of each organization in the clinical
development of new anticancer drugs. This expanded international collaboration also includes the
exchange of information and new drug candidates of mutual interest at all stages of pre-clinical and
clinical evaluation.
                                                                                                            1. Structure and Organisation

High priority drug candidates may, by mutual agreement, be assigned to any appropriate CRUK,
EORTC, SENDO or NCI laboratory or clinic that can help with or carry out a necessary step in
the development of the agent. Drugs are now developed in such a way that they may enter clinical
trials on either side of the Atlantic. Initial clinical trials are conducted according to mutually-agreed
protocols and in compliance with appropriate standards for the testing of experimental agents, so
as to facilitate the acceptability of data on Phase I results by the appropriate regulatory authorities.
Joint guidelines on pharmaceutical formulation were published in the European Journal of Cancer and
Clinical Oncology. Based on the current state-of-the-art, joint guidelines on pre-clinical toxicology are
made available and updated as necessary.
                                By mutual agreement this collaboration has been extended to provide new compounds of European
                                origin from the NCI in-vitro anticancer screening program to the European collaborative groups. A
                                review and selection committee composed of members of EORTC, and CRUK has so far reviewed the
                                data on more than 1000 compounds, of which numerous substances have been considered as being of
                                interest for potential further anticancer evaluation in Europe.
                                In order to facilitate the cooperation with the North American Cancer collaborative groups, EORTC
                                has been affiliated to the Office of Human Research Protection (OHRP) since 1998 (federal wide
                                agreement for intergroup collaboration).
                                Since 1998, the legal framework for clinical trials has been significantly revised on both sides of the
                                In December 2004, the NCI developed new regulatory guidelines with the Cancer Therapy Evaluation
                                Program (CTEP) on the conduct, development and analysis of clinical trials with international
                                collaborating institutions.
                                Within the framework of these newly developed CTEP guidelines and thanks to the existing affiliation
                                of EORTC with the OHRP, transatlantic cooperation has been facilitated significantly.
                                Multiple joint protocols involving EORTC and NCI-sponsored Cooperative Groups are currently in
                                progress. EORTC and NCI staff are working closely to harmonize pharmacovigilance, data collection,
                                and quality assurance.

                                The NCI Liaison Office (NCILO)

                                The NCI Liaison Office (NCILO) in Brussels, Belgium, situated adjacent to the EORTC headquarters,
                                is part of the Office of International Affairs, NCI, and is an integral part of the NCI. Its role is
                                to act as a European-based link to NCI cancer research and treatment programs in the United
                                States. It facilitates the interchange of information, ideas, experimental drugs, scientific expertise and
                                scientists between Europe and the US NCI. It works in close collaboration with the EORTC and
                                the British Cancer Research UK (CRUK) as well as with other European cancer research institutes
                                and pharmaceutical/chemical industries. Its role is to help create a network of cancer experts and
                                cancer centers between Europe and the US NCI which work towards a common goal, to enable rapid
                                progress in cancer research on an international scale.
                                Until the change to a web-based submission procedure, the NCI Liaison Office acquired approximately
                                2000 compounds per year from European sources for NCI’s in-vitro anticancer screening program.
1. Structure and Organisation

                                Pre-clinical collaborative agreements with European institutions, administered by the Office, are
                                providing important expertise on experimental tumour models development, human tumour cell lines,
                                and xenografts. These collaborative groups (e.g. Drug Discovery Committee (DDC) of the EORTC
                                Pharmacology and Molecular Mechanisms Group) also provide secondary evaluation of potentially
                                effective anticancer drugs originating from the NCI in-vitro screening program.
                                The Office also assists other NCI divisions and programs with their European activities. Furthermore,
                                it collects European cancer research protocols for the NCI International Cancer Research Data Bank
                                Branch, Office of Communications and Education, NCI, for inclusion in NCI’s clinical database PDQ
(Physician Data Query/Cancer Net ®). PDQ is a database which contains information on cancer
treatment research. PDQ allows investigators to have access to both ongoing US and European
protocols. In addition to the clinical studies under EORTC auspices, the inclusion of investigational
protocols was extended to national groups in the early 90s. These include protocols from e.g. CRUK,
MRC, SCTN and SIOP from the UK, NKB from the Netherlands, SAKK from Switzerland, the German
Cancer Society, FNCLCC from France, and from many other national groups. The NCI Liaison office
actively seeks new European groups with an interest to submit their research protocols to PDQ.
The PDQ database may be accessed via

NCI Liaison Office and the International Network For Cancer
Research and Treatment (INCTR)

The NCI LO has close interactions with the International Network for Cancer Research and Treatment
(INCTR), a unique organization dedicated to helping patients in developing countries, which is also
located in Brussels and partially supported by the NCI’s Office of International Affairs. The NCI
Liaison Office currently assists with some of the training and education activities.                    59

Telesynergy® Medical Consultation Workstation

The NCI Liaison Office is the European hub for NCI’s TELESYNERGY® Medical Consultation
WorkStation. The Telesynergy® Workstation allows numerous research collaborators at greatly
separated geographic sites to interact as if they were in the same room, viewing the same medical
images. By integrating powerful telecommunications technology into healthcare research and delivery,
telemedicine enables clinical researchers to simultaneously communicate and view and manipulate data
necessary for collaborations, including patient diagnosis and care, such as x-ray films and pathology
samples. The telemedicine system has high quality, multi-site teleconferencing
capabilities, and is also capable of transmitting most types of diagnostic-quality medical images and
information from several different sources, such as a microscope, a patient examination camera,
document camera, color video printer, DVD player/recorder, and PC applications.
By making the knowledge and experience of oncology experts accessible regardless of where in
the world those experts are, TELESYNERGY® has the potential to dramatically accelerate cancer
research and improve cancer care by facilitating unique collaborations and connections.
                                                                                                        1. Structure and Organisation

Amongst other collaborators, the European School of Oncology (ESO) makes use of the system for
their live webcasts/e-grandrounds.
The TELESYNERGY® Workstation is available at very low cost to outside collaborators. Interested
parties are welcome to use it.

                 For further information please contact the NCI Liaison Office:
            Phone: +32/2/772.22.17 - Fax: +32/2/770.47.54 - E-mail:
                                EORTC - European Journal of
                                E R C u o e no Collaborationla o a i n
                                 O T - r p a J r aoC n e ( J ) o
                                Cancer (EJC)u n l f a c rE CC l b r to
                                John Smyth, Editor in Chief

                                Impact factors remain an important part of a journal’s reputation. 2008 saw this increase yet again to
                                4.475 ranking it 36th out of 141 journals - signifying another excellent year for the Journal! The figure
                                below shows that the impact factor has increased steadily year on year since 2004. This is particularly
                                pleasing given that EJC has to compete with an ever increasing number of specialist cancer journals
                                in a world of electronic readership. In 2008 1675 manuscripts were submitted again a continued year
                                on year increase with the approximate rejection rate sitting at 80%. Although this is a big challenge
                                for the Editors it shows the continually increasing success of the Journal and therefore for the 20% of
                                authors whose manuscripts are accepted.
                                The very rapid response to authors with overall submission to publication time now averaging 22
                                weeks (up from 33 weeks) ensures that the reputation of the journal is maintained. The average time
                                to publish fully citeable articles-in-press remains at approximately 6 weeks. On-line usage of EJC
       60                       on Science Direct continues at the same high level of usage with 2008 showing more than 600 000
                                full text electronic downloads. The top 10 most frequently downloaded articles for 2008 show an
                                excellent balance between clinical, experimental, translational science and epidemiology papers. This
                                is encouraging to the Editors whose major challenge is to seek an appropriate balance between the
                                different categories of manuscripts published in the EJC.


                                                    Impact Factors


                                                                     2000      2004       2008

                                The 2008 Palliative Care Special issue was extremely well received at ASCO, and together with the
1. Structure and Organisation

                                highly topical subjects covered in other Special Issues (Cancer Control in Europe; CANULI; Advances
                                in Translational Research) these have continued to show the excellent value of commissioned work.
                                2009 has already seen the publication of some other topical Special issues; RECIST and EUROCARE
                                4 with Cervical Cancer being the next in publication. The Editors greatly welcome suggestions for
                                topics to be covered by special issues. EJC is the office journal of the European CanCer Organisation
                                (ECCO). Their interactive webpage ( offers not only promotion of EJC papers
                                through their quarterly highlights but also allows the opportunity to comment in any relevant way
                                through the EJC blogs and we greatly welcome communication via this opportunity.
The editors of EJC are most grateful for the contributions from members of EORTC both in the
submission of original research and help in refereeing submitted manuscripts.

            All correspondence and manuscript submissions should be addressed to:
                        The Editorial Office, European Journal of Cancer
                                 Elsevier Science, The Boulevard
                                    Langford Lane, Kidlington
                                        Oxford, OX5 | GB
                                         United Kigdom
                     Tel: +44(0) 1865 84 36 20 - Fax: +44(0) 1865 84 39 77
                            Administrative Editor: Suzanne Peedell:


                                                                                               1. Structure and Organisation
1. Structure and Organisation

2. The EORTC Network



                       2. The EORTC Network
                       EORTC Groups and Task Forces
                                       GROUP                       CHAIR                 SECRETARy

                                                                       M. WICK          B. BAUMERT
                       EORTC Brain Tumour                         Heidelberg (DE)      Maastricht (NL)
                                                                       T. CUFER        D. CAMERON
                       EORTC Breast Cancer                           Golnik (SL)         Leeds (UK)
                                                                      Y. BENOIT        Y. BERTRAND
                       EORTC Children’s Leukaemia                     Gent (BE)           Lyon (FR)
                                                                       M. LUTZ         M. DUCREUX
                       EORTC Gastrointestinal Tract Cancer       Saarbrucken (DE)       Villejuif (FR)
                                                                    S. OSANTO          H. KYNASTON
                       EORTC Genito-Urinary Tract Cancer             Leiden (NL)        Cardiff (UK)
                                                             A. CASADO-HERRAEZ         D.. KATSAROS
                       EORTC Gynaecological Cancer                   Madrid (ES)         Torino (IT)
                                                                J.A. LANGENDIJK         R. KNECHT
                       EORTC Head and Neck Cancer                 Groningen (NL)       Hamburg (DE)
     64                                                         S. STROOBANTS
                       EORTC Imaging                                Edegem (BE)
                                                                                     Pending nomination

                                                                   P. DONNELLY
                       EORTC Infectious Diseases                  Nijmegen (NL)
                                                                                     Pending nomination

                                                                      J-P. MARIE            M. LÜBBERT
                       EORTC Leukaemia                                Paris (FR)           Freiburg (DE)
                                                                     M. O’BRIEN            V. SURMONT
                       EORTC Lung Cancer                            Sutton (UK)               Gent (BE)
                                                             R.VAN DER MAAZEN              P. MEIJNDERS
                       EORTC Lymphoma                             Nijmegen (NL)           Antwerpen (BE)
                                                                        P. PATEL       D. SCHADENDORF
                       EORTC Melanoma                            Nottingham (UK)             Essen (DE)
                                                                     G.J. PETERS           E. CHATELUT
                       EORTC PAMM                                Amsterdam (NL)            Toulouse (FR)
                                                                  M.G. DAIDONE              J. DITTMER
                       EORTC PathoBiology                             Milano (IT)             Halle (DE)
                                                                    G.VELIKOVA      F. EFFICACE, Roma (IT)
                       EORTC Quality of Life                         Leeds (UK)      J. ARDILL, Belfast (UK)
                                                                   V. GREGOIRE           Ph. POORTMANS
                       EORTC Radiation Oncology                     Brussels (BE)           Tilburg (NL)
                                                               P. HOHENBERGER        W. VAN DER GRAAF
                       EORTC Soft Tissue and Bone Sarcoma         Mannheim (DE)           Nijmegen (NL)
2. The EORTC Network

                                    TASk FORCE                   CHAIRMAN               SECRETARy
                                                                 H. WILDIERS             U. WEDDING
                       EORTC Cancer in the Elderly               Leuven (BE)                Jena (DE)
                                                                  M. BAGOT          P.L. ORTIZ-ROMERO
                       EORTC Cutaneous Lymphoma                  Creteil (FR)             Madrid (ES)
EORTC Clinical Studies
EORTC Groups and Task Forces
Patient Accrual
Total accrual of patients in EORTC clinical studies in 2008:
4,978 patients

European Union:                                                        Non-EU Countries:
Austria:                  31                                           Croatia:              12
Belgium:                 608                                           Norway:                4
Cyprus:                    1                                           Switzerland:          79
Czech Republic:            3                                           Turkey:               17
Denmark:                  27
France:                1374
Germany:                 213
Italy:                   243
Latvia:                   11
Poland:                   55
Portugal:                 28
Republic of Ireland:       1
Slovak Republic:           9
Slovenia:                 33
Spain:                   178                                           Rest of the World: 156
Sweden:                   10
The Netherlands:       1,458
United Kingdom:          427

A number of EORTC trials are conducted in collaboration with other clinical cancer research groups
in Europe and also on other continents. These groups provide a complementary portfolio of cancer
clinical trials to the EORTC network and bring a valuable contribution to the recruitment within
EORTC led intergroup trials.
                                                                                                     2. The EORTC Network
                       Number of new patients entered in EORTC Clinical Studies per country
                       (by EORTC Groups)

                                    COUNTRy                  2008
                                                                                     2000 – 2008
                        EU Countries (26)
                        Austria                                   27                         650
                        Belgium                                  580                       5,586
                        Bulgaria                                    0                         49
                        Cyprus                                      1                         73
                        Czech Republic                              3                        122
                        Denmark                                   27                         410
                        Estonia                                     0                          6
                        Finland                                     0                         20
                        France                                   900                       8,596
                        Germany                                  181                       3,433
                        Greece                                      0                         48
     66                 Hungary                                     0                        180
                        Italy                                    122                       3,731
                        Latvia                                    11                          34
                        Luxemburg                                   0                          9
                        Malta                                       0                         20
                        Poland                                    55                         976
                        Portugal                                  28                         617
                        Republic of Ireland                         1                         90
                        Romania                                     0                         20
                        Slovak Republic                             9                        396
                        Slovenia                                  25                         240
                        Spain                                     23                       1,081
                        Sweden                                      7                        309
                        The Netherlands                          736                       9,241
                        United Kingdom                           365                       5,145
                        TOTAL EU                    3,101 patients (95,01 %)   41,082 patients (90,70 %)

                        Non-EU Countries (7)
                        Bosnia                                     0                          8
                        Croatia                                   12                        324
                        Macedonia                                  0                          6
                        Norway                                     4                        412
2. The EORTC Network

                        Russia                                     0                        104
                        Switzerland                               76                        993
                        Turkey                                    17                        607
                        TOTAL NON-EU Countries       109 patients (3,34 %)     2,4541 patients (5,42 %)
             COUNTRy                            2008
                                                                          2000 – 2008
Rest of the World (11)
Argentina                                             0                            80
Australia                                             0                          115
Canada                                               14                          234
Chile                                                 0                            92
Egypt                                                18                          291
Hong-Kong                                             0                             6
Israel                                               12                          359
Lebanon                                               0                            14
Mexico                                                0                             1
New Zealand                                           0                             5
Peru                                                  8                            65
Saudi Arabia                                          0                            15
Serbia                                                2                          244
South Africa                                          0                            45
Taiwan                                                0                          138           67
U. A. Emirates                                        0                             2
U.S.A.                                                0                            52
TOTAL Rest of the World                 54 patients (1,65 %)         1,758 patients (3,88 %)

TOTAL of Patients Recruited                 3,264 patients              45,294 patients

Patient accrual by EORTC Groups (excluding non-EORTC Groups)

                 EORTC GROUP                                 2008
                                                                              2006 -2008
EORTC Brain Tumor Group                                        344                778
EORTC Breast Cancer Group                                    1,374              3,046
EORTC Children's Leukemia Group                                113                549
EORTC Cutaneous Lymphoma Task Force                             22                 64
EORTC Gastrointestinal Tract Cancer Group                      305                623
EORTC Genito-Urinary Tract Cancer Group                        117                501
EORTC Gynecological Cancer Group                                79              1,061
EORTC Head and Neck Cancer Group                                12                 15
EORTC Infectious Diseases Group                                 75                366
                                                                                               2. The EORTC Network

EORTC Leukemia Group                                            27                660
EORTC Lung Cancer Group                                        106                277
EORTC Lymphoma Group                                           177                412
EORTC Melanoma Group                                            35                612
EORTC Radiation Oncology Group                                 556              1,671
EORTC Soft Tissue and Bone Sarcoma Group                       322              1,202
EORTC Network of Core Institutions                              29                138
                       EORTC Intergroup Collaboration
                       Nowadays, many cancer research groups conduct clinical trials, and within this framework closer
                       collaboration between research groups is essential to minimize the number of competitive trials and
                       to accrue large numbers of patients in a minimum period of time. These collaborative clinical trials
                       are called “Intergroup” trials.
                       In order to guarantee the quality of these trials and to facilitate their coordination and logistics, the
                       EORTC has developed policies specific to this type of trials. These policies have been made taking into
                       account the legal requirements in Europe, but also policies of main cancer research groups outside
                       Europe (such as NCI policies).
                       Following these policies all groups use the same protocol, the same set of CRFs, and a central database
                       which is the first guarantee for consistency of results.
                       A Steering Committee composed of representatives from all participating groups decides on the
                       scientific content of the trial and possible future use made of the material, data, and results. The
                       data from all collaborating groups are gathered at one headquarter for cleaning and analysis in order
     68                to provide a global view of the data (particularly the safety data) and a homogeneous update and
                       validation process.
                       Apart from the centralisation of data, the coordinating centre (whether it be EORTC Headquarters
                       or another independent data centre) globally ensures the coordination of the trial logistics and legal
                       This coordinating role became essential within the new legal framework in the EU. The EU lead group
                       shall, among other tasks, ensure that request of EudraCT number, completion of the clinical trial
                       application form and the reporting to the EUDRAVIGILANCE database are taken care of centrally.
                       The responsibilities are discussed on a trial-by-trial basis and fixed through written agreements
                       between different partners.
                       These policies have been applied by the EORTC for several years and have resulted in an important
                       number of collaborations with many European and overseas cancer clinical research groups.
                       There are currently a total of 21 ongoing intergroup trials of which 13 are coordinated by EORTC
                       Headquarters, whereas the remaining 8 are coordinated by other data centres. Two trials are
                       transatlantic, large intergroups in collaboration with NCI collaborative groups. More intergroup trials
                       are in the development process.
2. The EORTC Network
Contribution by non-EORTC Groups to EORTC Trials in 2008

Borstkanker Onderzoeksgroup Nederland
Federation Nationale des Centres de Lutte contre le Cancer
Groupe d'Etudes des Lymphomes de l'Adulte
Grupo espanol de estudio, tratamiento y otras estrategias ex
Intergruppo Italiano Linfomi
ALMANAC Trialists Group
National Cancer Institute of Canada-Clinical Trial Group
Gruppo Italiano Malattie Ematologiche dell'Adulto
National Cancer Research Institute - Breast Cancer Group
West German Study Group
Gruppo Oncologico Italiano Ricercia Clinica
Italian Sarcoma Group
French Sarcoma Group
Australasian Gastro-Intestinal Trials Group
Grupo Espanol de Investigacion en sarcomas
Medical Research Council
Trans-Tasman Radiation Oncology Group Inc
Arbeitsgemeinschaft Gynaekologische Onkologie
Australasian Leukaemia and Lymphoma Group
Groupe d'Invest. Nationaux pour Etude Cancers Ovariens
National Cancer Research Institute - Bladder Cancer Group-UK
Grup per l'Estudi del Limfomes de Catalunya i Balears
                                                               2. The EORTC Network

Mario Negri Gynecologic Oncology Group
Australia & New Zealand Gynaecological Oncology Group
Grupo Germinal - IT
International Breast Cancer Study Group
Italian Lung Cancer Project
                       EORTC Affiliated Institutions
                       and DepartmentsInstitutionsandDepartments
                       The EORTC has established criteria to grant recognition to Institutions/Departments actively
                       participating in EORTC clinical trials. This list of Institutions/Departments is updated on a yearly basis.
                       An Institution can either be granted recognition as an ‘EORTC Affiliated Institution’ or as an ‘EORTC
                       Affiliated Department’.
                       The criteria used to merit that recognition are:
                       EORTC Affiliated Institution:
                       1. Recruitment of 75 patients over a period of three years with a minimum of 15 patients entered in
                          EORTC clinical trials per year.
                       2. Participation in at least three EORTC Groups.
                       EORTC Affiliated Department:
                       1. Recruitment of 75 patients over a period of three years with a minimum of 15 patients entered in
                          EORTC clinical trials per year.
                       2. Participation in less than three EORTC Groups.

                       EORTC Affiliated Institutions per Country 2009
                       (Review period 2006-2008)

                       European Union:                                                        Non-EU Countries:
                       Belgium: 6                                                             Egypt: 1
                       France: 7                                                              Switzerland: 2
                       Germany: 1
                       Poland: 2
                       The Netherlands: 9
                       United Kingdom: 4
2. The EORTC Network
Ranking of EORTC Affiliated Institutions in 2009
(Review period 2006-2008)

The following institutions have been recognized in 2009 as EORTC Affiliated Institutions based
on their participation in EORTC studies over the last three years.

                                                                          ACCRUAl ACCRUAl
RANk                    INSTITUTION                  COUNTRy      OFEORTC
                                                                           2008   2006-2008
       The Netherlands Cancer Institute-Antoni Van    The
  1                                                                    8     149      404
       Leeuwenhoekzieke, Amsterdam                 Netherlands
       Hopitaux Universitaires Bordet-Erasme,
  2                                                 Belgium            13    103      369
       Arnhem’s Radiotherapeutisch Instituut,         The
  3                                                                    4     87       332
       Arnhem & Harderwijk                         Netherlands
  4    Institut Gustave Roussy,Villejuif              France           9     144      318
  5    UZ Leuven, Leuven                              Belgium          11    79       292        71
       Radboud University Nijmegen Medical             The
  6                                                                    12    54       272
       Centre, Nijmegen                             Netherlands
  7    Centre Leon Berard, Lyon                       France           6     48       223
  8    UZ Rotterdam, Rotterdam                                         9     61       218
  9    Leiden University Medical Centre, Leiden                        8     55       211
 10    Institut Curie, Paris                          France           5     124      185
 11    Institut Bergonie, Bordeaux                    France           7     79       179
       Centre Hospitalier Universitaire Vaudois,
 12                                                 Switzerland        7     28       145
 13    Cliniques Universitaires St. Luc, Brussels    Belgium           6     72       141
 14    Academisch Medisch Centrum, Amsterdam                           6     42       138
 15    Centre Georges-Francois-Leclerc, Dijon         France           5     65       133
       Universitair Medisch Centrum - Academisch       The
 16                                                                    5     50       132
       Ziekenhuis, Utrecht                          Netherlands
       University Medical Center Groningen,            The
 17                                                                    6     36       127
       Groningen                                    Netherlands
                                                                                                 2. The EORTC Network

 18    Centre Regional Francois Baclesse, Caen        France           3     70       115
 19    NHS Greater Glasgow and Clyde Hospitals                         7     33       114
 20    Universiteit Gent, Gent                        Belgium          6     24       111
 21    CHU de Lyon, Lyon & Pierre-Benite              France           6     19       106
                                                                                                  ACCRUAl ACCRUAl
                       RANk                    INSTITUTION                   COUNTRy      OFEORTC
                                                                                                   2008   2006-2008
                              Medisch Centrum Haaglanden, Den Haag &           The
                        22                                                                     4     39      106
                              Leidschendam                                  Netherlands
                        23    Royal Marsden Hospital, London & Sutton                          4     30      103
                              Maria Sklodowska-Curie Cancer Center,
                        24                                                    Poland           5     25      102
                        25    Leeds Teaching Hospitals NHS Trust, Leeds                        5     25      100
                        26    National Cancer Institute, Cairo                 Egypt           3     18       94
                              Klinikum Mannheim gGmbH,
                        27                                                   Germany           3     25       90
                              Universitaetsklinikum, Mannheim
                        28    Christie Hospital, Manchester                                    6     43       90
                              Hopital Cantonal Universitaire De Geneve,
     72                 29                                                  Switzerland        5     32       86
                        30    Universitair Ziekenhuis Antwerpen, Edegem      Belgium           9     40       81
                        31    Medical University of Gdansk, Gdansk            Poland           4     26       81
                              Cliniques Universitaires de Mont Godinne,
                        32                                                   Belgium           4     32       75
                              TOTAL Number of Patients                                              1757     5283

                       Ranking of EORTC Affiliated Departments in 2009
                       (Review period 2006-2008)

                       The following institutions have been recognized in 2009 as EORTC Affiliated Departments based
                       on their participation in EORTC studies over the last three years.

                                                                                                  ACCRUAl ACCRUAl
                       RANk                    INSTITUTION                   COUNTRy      OFEORTC
                                                                                                   2008   2006-2008
                              Radiotherapeutisch Instituut Friesland,          The
                         1                                                                     2     29      121
                              Drachten & Leeuwarden                         Netherlands
2. The EORTC Network

                              Univ. Degli Studi Di Firenze - Policlin. Di
                         2                                                     Italy           2     18       98
                              Careggi, Firenze
                         3    University College Hospital, London                              2     27       76
                              TOTAL Number of Patients                                               74      295
3. EORTC Current Research and

     Where to obtain information on
            EORTC Open Protocols?

   Updated Information on all ongoing EORTC Protocols
            is available on the EORTC Website

                 For all EORTC Protocols,
  patients can be randomised online at the EORTC Website


                                                           3. EORTC Current Research and Strategies
                                           EORTC Open Protocols
                                           EORTC Open Protocols As of "Date"
                                           as of August 2009
                                           PROTOCOl                                      TITlE

                                                      EORTC Boron Neutron Capture Therapy Group (closed group)
                                                      10B-uptake in different tumours using the boron compounds BSH and
                                            11001                                                                                27
                                                      Trial Coordinator:
                                                      Wolfgang Sauerwein - Universitaetsklinikum - Essen, Essen
                                                                          EORTC Brain Tumour Group
                                                      Cilengitide in subjects with newly diagnosed glioblastoma and
                                                      methylated MGMT promoter gene- a multicenter, open-label, controlled
                                                      Phase III study, testing cilengitide in combination with standard
                                            26071     treatment (temozolomide with concomitant radiation therapy, followed
          74                                          by temozolomide maintenance therapy) versus standard treatment            504
                                                      Trial Coordinator:
                                                      Roger Stupp - Centre Hospitalier Universitaire Vaudois, Lausanne
                                                                         EORTC Breast Cancer Group
                                                      A phase I-II study of Lapatinib and Docetaxel as neoadjuvant treatment
                                                      for locally advanced breast cancer.
                                            10054     Trial Coordinators:                                                       114
                                                      Herve Bonnefoi - Institut Bergonie, Bordeaux
                                                      David Cameron - NCRN Coordinating Centre - University of Leeds
                                                                  EORTC Cutaneous Lymphoma Task Force
                                                      A randomised, open-label phase III trial to evaluate the efficacy and
3. EORTC Current Research and Strategies

                                                      safety of Bexarotene (Targretin TM) capsules combined with PUVA,
                                            21011     compared to PUVA treatment alone in patients with Mycosis Fungoides.      140
                                                      Trial Coordinator:
                                                      Sean Whittaker - Guys & St Thomas Hospital, London
                                                      Phase II clinical trial with Caelyx mono-chemotherapy in patients with
                                                      advanced Mycosis Fungoides stage IIb, IVa and IVb with or without
                                            21012     previous chemotherapy.                                                     48
                                                      Trial Coordinator:
                                                      Reinhard Dummer - Universitaetsspital, Zurich
PROTOCOl                                      TITlE

                     EORTC Genito-Urinary Tract Cancer Group
           Phase I study of cisplatin, gemcitabine (+ paclitaxel) and lapatinib as first
           line treatment in advanced/metastatic urothelial cancer
 30061                                                                                        -
           Trial Coordinator:
           Gedske Daugaard - Rigshospitalet, Copenhagen
                         EORTC Gynaecological Cancer Group
           Randomized phase III study of neoadjuvant chemotherapy followed by
           surgery vs. concomitant radiotherapy and chemotherpy in FIGO Ib2, IIa
           > 4 cm or IIb cervical cancer.
           Trial Coordinators:
 55994     Alessandro Colombo - Ospedale Alessandro Manzoni, Lecco                          686
           Stefano Greggi - Istituto Nazionale Per Lo Studio E La Cura Dei Tumori,                   75
           Gemma Kenter - Leiden University Medical Centre, Leiden
           Fabio Landoni - Istituto Europeo Di Oncologia, Milano
                               EORTC Head & Neck Group
           Randomized phase II feasibility study of Cetuximab combined with 4
           cycles of TPF followed by platinum based chemo-radiation strategies
 24061                                                                                       55
           Trial Coordinator:
           Jan Baptist Vermorken - Universitair Ziekenhuis Antwerpen, Edegem
                               EORTC Lung Cancer Group
           Phase II study of bortezomib with cisplatin as first line treatment of
           malignant mesothelioma
 08052                                                                                       76

                                                                                                     3. EORTC Current Research and Strategies
           Trial Coordinator:
           Mary O'Brien - Royal Marsden Hospital, Sutton
           Phase II study of sunitinib (SU11248) in patients with small cell lung
           cancer who are either chemo-naïve (extensive disease) or have a
 08061     "sensitive" relapse.                                                              48
           Trial Coordinator:
           Egbert F. Smit - Vrije Universiteit Medisch Centrum, Amsterdam
           Randomization phase II study of amrubicin as single agent or in
           combination with cisplatin versus etoposide-cisplatin as first-line
 08062     treatment in patients with extensive stage SCLC (ES).                             81
           Trial Coordinator:
           Mary O'Brien - Royal Marsden Hospital, Sutton
                                           PROTOCOl                                       TITlE

                                                                            EORTC Melanoma Group
                                                      Intravenous versus intra-arterial fotemustine chemotherapy in patients
                                                      with liver metastases from uveal melanoma : a randomized phase III
                                            18021     study of the EORTC Melanoma Group.                                          262
                                                      Trial Coordinator:
                                                      Serge Leyvraz - Centre Hospitalier Universitaire Vaudois, Lausanne
                                                      Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody
                                                      (ipilimumab) versus placebo after complete resection of high-risk Stage
                                                      III melanoma : A randomized, double-blind Phase 3 trial of the EORTC
                                            18071     Melanoma Group.                                                             950

                                                      Trial Coordinator:
                                                      Alexander Eggermont - Erasmus University Medical Center, Rotterdam
          76                                                          EORTC Radiation Oncology Group
                                                      Adjuvant postoperative high-dose radiotherapy for atypical and
                                            22042     malignant meningioma : a Phase II and observation study.
                                            26042     Study Coordinator:
                                                      Damien C. Weber - Hopital Cantonal Universitaire De Geneve, Geneve
                                                      Post-operative external radiotherapy combined with concomitant
                                                      and adjuvant hormonal treatment versus post-operative external
                                                      radiotherapy alone in pathological stage pT3a-b R0-1/pT2R1 N0M0,
                                            22043     Gleason score 5-10 prostatic carcinoma. A phase III study.                  600
                                                      Study Coordinators:
                                                      Michel Bolla - Chr De Grenoble - La Tronche, Grenoble
                                                      Hein Van Poppel - U.Z. Gasthuisberg, Leuven
3. EORTC Current Research and Strategies

                                                                EORTC Soft Tissue and Bone Sarcoma Group
                                                      Phase II study of E7389 administered as an IV infusion on day 1 and 8
                                                      every 3 weeks in pretreated patients with advanced and/or metastatic
                                            62052     soft tissue sarcoma                                                         148
                                                      Trial Coordinator:
                                                      Patrick Schoeffski - U.Z. Gasthuisberg, Leuven
                                                      A randomized double blind phase III trial of Pazopanib versus placebo in
                                                      patients with soft tissue sarcoma whose disease has progressed during
                                            62072     or following prior therapy.                                                 255
                                                      Trial Coordinator:
                                                      Winette Van Der Graaf - Radboud University Medical Centre, Nijmegen
Intergroup Trials
Coordinated by the EORTC
EORTC Open Protocols As of "Date"
as of August 2009
PROTOCOl                                       TITlE

                                EORTC Brain Tumour Group
           Phase III trial on concurrent and adjuvant temozolomide chemotherapy
           in non-1p/19q deleted anaplastic glioma. The CATNON intergroup trial.
 26053     Other participating Groups:                                                    748
 22054     Medical Research Council
           National Cancer Institute of Canada-Clinical Trial Group
           Radiation Therapy Oncology Group
                               EORTC Breast Cancer Group
           MINDACT (Microarray In Node-negative Disease may avoid
           Chemotherapy): A prospective, randomised study comparing the 70-
           gene signature with the common clinic-pathological criteria in selecting                77
           patients for adjuvant chemotherapy in node-negative breast cancer.
           Other participating Groups:
           Borstkanker Onderzoeksgroup Nederland
           Breast International Group
 10041     Federation Nationale des Centres de Lutte contre le Cancer                     6000
           Grupo espanol de estudio, tratamiento y otras estrategias experimentales en
           tumores solidos
           Gruppo Oncologico Italiano Ricercia Clinica
           Ireland Cooperative Oncology Research Group
           National Cancer Research Institute - Breast Cancer Group
           West German Study Group
           After Mapping of the Axilla:Radiotherapy Or Surgery AMAROS

                                                                                                   3. EORTC Current Research and Strategies
 10981     Other participating Groups:                                                    3485
 22023     ALMANAC Trialists Group
           Borstkanker Onderzoeksgroup Nederland
                                           PROTOCOl                                       TITlE

                                                                EORTC Gastrointestinal Tract Cancer Group
                                                      Preoperative chemoradiotherapy and postoperative chemotherapy with
                                                      capecitabine and oxaplatin vs.capecitabine alone in locally advanced
                                                      rectal cancer (PETACC-6).

                                            40054     Other participating Groups:
                                                      Arbeitsgemeinschaft Internistische Onkologie, Chirurgische                 1090
                                                      Arbeitsgemeinschaft fuer Onkologie
                                                      Australasian Gastro-Intestinal Trials Group
                                                      Belgian Group of Digestive Oncology
                                                      Federation Francophone de Cancerologie Digestive
                                                                 EORTC Genito-Urinary Tract Cancer Group
                                                      Randomized phase II/III study of Taxol-BEP versus BEP in patients with
                                                      intermediate prognosis germ cell cancer
                                            30983     Other participating Groups:                                                498
                                                      German Testicular Cancer Study Group
                                                      Grupo Germinal - IT
                                                      Medical Research Council
                                                                       EORTC Infectious Diseases Group
                                                      Fungemia Survey in Cancer Patients

                                            65031     Other participating Groups:                                                  -
                                                      Deutsche Gesellschaft fuer Haematologie und Onkologie
                                                      European Bone Marrow Transplantation
                                                                            EORTC Leukaemia Group
                                                      Gemtuzumab ozogamicin (GO) monotherapy versus standard
                                                      supportive care for previously untreated AML in elderly patients who
3. EORTC Current Research and Strategies

                                                      are not eligible for intensive chemotherapy : a randomized phase II/III
                                            06031     trial (AML-19) of the EORTC-LG and GIMEMA-ALWP.                            260

                                                      Other participating Group:
                                                      Gruppo Italiano Malattie Ematologiche dell'Adulto
                                                      Clofarabine in combination with a standard remissioninduction regimen
                                                      (AraC and idarubicin) in patients 18-60 years old with previously
                                                      untreated intermediate and bad risk acute myelogenous leukemia (AML)
                                            06061     or high risk myelodysplasia (MDS) : a phase I-II study of the EORTC-LG     120
                                                      and GIMEMA (AML-14A trial)
                                                      Other participating Group:
                                                      Gruppo Italiano Malattie Ematologiche dell'Adulto
PROTOCOl                                       TITlE

                                 EORTC Lymphoma Group
           BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8
           cycles) in stage III & IV Hodgkin's Lymphoma
           Other participating Groups:
           Australasian Leukaemia and Lymphoma Group
 20012     Groupe d'Etudes des Lymphomes de l'Adulte                                    550
           Grup per l'Estudi del Limfomes de Catalunya i Balears
           National Cancer Institute of Canada-Clinical Trial Group
           National Cancer Research Institute - Lymphoma Group-UK
           Nordic Lymphoma Group
           The H10 EORTC/GELA randomized Intergroup trial on early FDG-PET
           scan guided treatment adaptation versus standard combined modality
           treatment in patients with supradiaphragmatic stage I/II Hodgkin's
 20051     lymphoma.                                                                    1576
           Other participating Groups:
           Groupe d'Etudes des Lymphomes de l'Adulte
           Intergruppo Italiano Linfomi
                           EORTC Radiation Oncology Group
           Primary chemotherapy with temozolomide vs.radiotherapy in patients
           with low grade gliomas after stratification for genetic 1p loss : a phase
           III study
           Other participating Groups:                                                  700
           Medical Research Council
           National Cancer Institute of Canada-Clinical Trial Group
           Trans-Tasman Radiation Oncology Group Inc
                     EORTC Soft Tissue and Bone Sarcoma Group

                                                                                                 3. EORTC Current Research and Strategies
           Randomised trial of single agent doxorubicin versus doxorubicin plus
           ifosfamide in the first line treatment of advanced or metastatic soft
 62012     tissue sarcoma                                                               450
           Other participating Group:
           National Cancer Institute of Canada-Clinical Trial Group
                                           PROTOCOl                                        TITlE

                                                      A phase III randomized study evaluating surgery of residual disease in
                                                      patients with metastatic gastro-intestinal stromal tumor responding to
                                                      Imatinib mesylate.

                                            62063     Other participating Group:                                                350
                                                      Australasian Gastro-Intestinal Trials Group
                                                      French Sarcoma Group
                                                      Italian Sarcoma Group
                                                      Scandinavian Sarcoma Group

3. EORTC Current Research and Strategies
Intergroup Trials
Not Coordinated by the EORTC
as of August 2009
PROTOCOl                                      TITlE

                               EORTC Breast Cancer Group
           A Phase III Trial Evaluating the Role of Ovarian Function Suppression
           and the Role of Exemestane as Adjuvant Therapies for Premenopausal
           Women with Endocrine Responsive Breast Cancer tamoxifen versus
 10031     ovarian function suppression + tamoxifen versus ovarian function             3000
           suppression + exemestane
           Coordinating Group:
           International Breast Cancer Study Group
           A randomised, multi-centre, open-label, phase III study of adjuvant
           lapatinib, trastuzumab, their sequence and their combination in patients
 10071     with HER2/ErbB2 positive primary breast cancer                               8000     81
           Coordinating Group:
           Breast European Adjuvant Studies Team
                          EORTC Children's Leukaemia Group
           International collaborative treatment protocol for infants under one
           year with acute lymphoblastic or biphenotypic leukemia
 58051                                                                                  445
           Coordinating Group:
           Operating Center for Research and Statistics
                     EORTC Gastrointestinal Tract Cancer Group
           Adjuvant treatment of fully resected stage III colon cancer with folfox-4
           versus folfox-4 plus cetuximab (PETACC-8)
 40052                                                                                  2000
           Coordinating Group:

                                                                                                 3. EORTC Current Research and Strategies
           Federation Francophone de Cancerologie Digestive
                     EORTC Genito-Urinary Tract Cancer Group
           A Phase III Randomised Double-blind Study Comparing Sorafenib With
           Placebo In Patients With Resected Primary Renal Cell Carcinoma at
 30072     High or Intermediate Risk of Relapse                                         1656
           Coordinating Group:
           Medical Research Council
                                           PROTOCOl                                         TITlE

                                                                            EORTC Leukaemia Group
                                                      A phase III randomized, Double-blind study of induction (Daunorubicin/
                                                      Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy
                                                      + Midostaurin (PKC 412) (IND # TBD) or Placebo in newly diagnosed
                                            06071     patients <60 years of age with FLT3 mutated acute myeloid leukemia         580
                                                      Coordinating Group:
                                                      Cancer and Leukemia Group B
                                                                               EORTC Lung Group
                                                      Concurrent once-daily versus twice-daily radiotherapy : A 2-arm
                                                      randomised controlled trial of concurrent chemo-radiotherapy
                                                      comparing twice-daily and once-daily radiotherapy schedules in patients
                                            08072     with limited stage small cell lung cancer (SCLC) and good performance
          82                                22074
                                                      Coordinating Group:
                                                      Christie's Hospital
                                                                      EORTC Radiation Oncology Group
                                                      Selective Use of Postoperative Radiotherapy After Mastectomy
                                                      Coordinating Group:                                                        3700
                                                      Scottish Cancer Trials Breast Group
3. EORTC Current Research and Strategies
Reports from the EORTC Groups
Reports from the EORTC Groups
and Task Forces

             For an update of information
    related to any EORTC Group or Task Force or
to request information about the schedule of a Group
  or Task Force meeting, please consult the EORTC
    website at where all details will
                      be posted

                                                       3. EORTC Current Research and Strategies
                                           Brain Tumour Group
                                           Structure of the Group

                                           Chair                                                   W. Wick, Heidelberg (DE)
                                           Secretary                                               B.G. Baumert, Maastricht (NL)
                                           Treasurer                                               M. Sanson, Paris (FR)
                                           Chair Pathology Committee                               M. Kros, Rotterdam (NL)
                                           Chair Translational Research Committee                  M. Hegi, Lausanne (CH)
                                           Chair QA Committee                                      to be appointed
                                           Young Oncologists                                       E. Franceschi, Bologna (IT)
                                                                                                   M. Preusser, Vienna (AT)
                                           The primary aim of the Brain Tumour Group (BTG) is to conduct, develop, coordinate and stimulate
                                           clinical and translational research for the treatment of primary and secondary brain tumours. The
                                           BTG aims at a better understanding of the development of brain tumours and at the development of
          84                               novel and more efficacious treatments to prolong the lives of brain tumour patients and to improve
                                           their quality of life.

                                           Recent Achievements

                                           • Completion of the RTOG 0525 study carried out in collaboration with RTOG.
                                           • Completion of phase II studies on erlotinib and epothilone in recurrent glioblastoma.
                                           • Completion of the joint ROG/BTG study on the treatment of brain metastases.
                                           • Completion of phase I enzastaurin/temozolomide study.
                                           • Completion of further translational research projects on EORTC 26951, adjuvant PCV in
                                             anaplastic oligodendroglial tumours.
3. EORTC Current Research and Strategies

                                           The successful and rapid completion of the landmark study in newly diagnosed glioblastoma (GBM)
                                           (EORTC 26981/22981-NCIC CE.3) proved the role of chemotherapy early in the course of the
                                           disease concomitant with radiotherapy. The results as published in the New England Journal of
                                           Medicine, have led to the rapid adoption worldwide of this treatment scheme as the new standard
                                           of care. Provocative results from this study, identifying MGMT promoter methylation as a predictive
                                           molecular marker, are being validated in a large ongoing intergroup study (a collaboration of the
                                           North American Radiation Therapy Oncology Group [RTOG] and the EORTC). In a joint effort, 1,173
                                           patients were accrued in just over 2 years (16% from the EORTC). After completion of concomitant
                                           temozolomide [TMZ] and radiotherapy [RT], patients were randomised to either the standard dose
                                           TMZ or an intensified dose-dense regimen aimed at improving response by depleting O6-methyl-
                                           guanyl-methyltransferase (MGMT) in the tumour tissue. Molecular markers and in particular MGMT
                                           promoter methylation status will be assessed in all patients.
The objective is to prospectively validate MGMT as a predictive marker for choosing alkylating
agent chemotherapy – a first step toward individualized treatments – and at testing strategies to
overcome resistance mediated by this repair protein. This study marks a first successful collaboration
between a US Cooperative Group and the EORTC BTG. It has further set the stage for the now
almost standard collaboration of North-American Cooperative Groups and EORTC for several other
subtypes of glioma, allowing the investigation, in a randomized fashion, of those burning questions
of the management of primary brain tumours. Furthermore, all these trials now include mandatory
submission and review of tumour material, and characterization with modern molecular methods.
This is an important step towards individualizing future therapies.
The joint Radiation Oncology Group/Brain Tumour Group study on the treatment of brain metastases
has been completed with 359 patients accrued and results will be presented at ASCO 2009.
The recently completed trial investigating adjuvant PCV chemotherapy after radiotherapy in the more
chemosensitive anaplastic oligodendroglioma and oligoastrocytoma (EORTC 26951), did not show a
statistically significant difference in survival, although progression-free survival was prolonged. We
concluded that chemotherapy has a clear role in this disease. However, the timing of administration
(initially/adjuvant or at progression) is of lesser importance. Molecular characterization demonstrated
a different natural history in a subgroup of oligodendroglioma with 1p/19q deletion (recently identified   85
as a translocation). In future trials, separate treatment strategies will be developed for this distinct
biological entity with a more favourable prognosis. Currently ongoing projects are further exploring
the molecular profiles of the tumours treated within this study, especially MGMT promoter gene
status and isocitrate dehydrogenase (IDH)1 and IDH2 mutations.
Analysis of the health-related quality of life (HRQOL) data from EORTC 26981 and 26951 showed
that the addition of chemotherapy has only a limited and transient negative impact on HRQOL during
and shortly following treatment. Not unexpected, temozolomide had less negative impact than PCV.
Baseline HRQOL data demonstrated no additional prognostic significance compared to clinical data.
Future studies should include longitudinal HRQOL measurements, especially following radiological
recurrence. From the patient perspective, time to clinical deterioration may be a more relevant
endpoint than time to progression if this progression is still asymptomatic. To meet this requirement,
the validation of novel and more clinical endpoints is required.
Novel drugs have been tested in a series of phase I and phase II studies in glioblastoma and anaplastic

                                                                                                           3. EORTC Current Research and Strategies
glioma. Recent agents under investigation are lonafarnib, enzastaurin, and sagopilone. Erlotinib, an
EGFR tyrosine kinase inhibitor [TKI], has been evaluated in a randomized phase II trial. In contrast
to previous reports from the USA of promising activity of this drug as a single agent in recurrent
glioma, our trial did not show significant activity in recurrent glioblastoma; outcome was similar to
treatment with carmustine or TMZ. Also, the finding of a molecular profile associated with response
to EGFR TKI inhibitors in US trials could not be confirmed in this trial. A phase I study of combined
chemo-irradiation (TMZ/RT) adding the VEGFR TKI PTK 787 demonstrated feasibility and safety.
Unfortunately, the drug manufacturer decided to discontinue development of this agent and the
planned randomized phase II study was not started.
                                           Project / Strategies for the coming years

                                           Comparing stereotactic re-irradiation of recurrent gliomas with target volume definition based on
                                           PET or on MR imaging.
                                           Phase II lomustine/dasatinib in recurrent GBM.
                                           Ongoing Phase III Co-del (companion study to CATNON).
                                           Phase II temsirolimus for non methylated glioblastoma (companion study to CENTRIC).
                                           Continuation of the CENTRIC study, a study assessing the addition of cilengitide to combined chemo-
                                           irradiation with temozolomide in newly diagnosed glioblastoma with a methylated MGMT promoter
                                           Start up of the study on hypofractionated RT with or without temozolomide in elderly glioblastoma
                                           patients (co-project with the NCIC).
                                           Continuation of the atypical and malignant meningioma study.
          86                               Continuation of the LGG study.
                                           Continuation of research on the results of the 26951 study on procarbazine, CCNU and Vincristine.
                                           Pathology – virtual microscopy project for pathology review and teaching purposes.
                                           Development of a protocol in Sunitinib in brain metastases from breast cancer.
                                           Quality of Life in long term survivors in EORTC study 26981.
                                           The EORTC BTG is playing a leading role in the large transatlantic intergroup effort on the treatment
                                           of brain tumours. The EORTC-led CATNON (EORTC 26053/22054) trial in grade III anaplastic
                                           gliomas is a joint effort by EORTC, RTOG, NCI Canada, the German Cancer Society (NOA) and
                                           the British MRC). For patients with co-deleted tumours on 1p/19q the protocol for a separate trial
                                           is being finalized and will be activated in 2009. For this group of patients with a more favourable
                                           outcome, long-term toxicity is a major concern. Consequently, neuro-cognitive testing is a major
                                           endpoint. Strategies of combined TMZ/RT will be compared to upfront chemotherapy with TMZ
3. EORTC Current Research and Strategies

                                           alone, or primary RT.
                                           The NCI Canada and the EORTC BTG are conducting a joint study in elderly GBM patients, a group
                                           of patients with a relatively poor prognosis, and in whom less intensive treatment strategies are being
                                           In newly-diagnosed GBM patients, we are investigating the integrin inhibitor cilengitide in combination
                                           with standard TMZ chemoradiation followed by adjuvant TMZ chemotherapy. In an uncontrolled
                                           phase II study improved outcome was suggested in particular in the subgroup of patients with a
                                           methylated MGMT gene promoter, thus more sensitive to TMZ chemotherapy. This trial is being
                                           conducted in a close and novel collaboration with the manufacturer, Merck-Serono as an international
                                           effort, led jointly by the EORTC and the Sponsor. For patients without MGMT promoter methylation,
                                           a series of phase II studies will explore alternative strategies to improve outcome. One candidate
                                           agent under exploration is temsirolimus (CCI-779), an inhibitor of mammalian target of rapamycin
                                           (mTOR). Other projects are being pursued, in particular with anti-angiogenic agents.
Quality Assurance

In collaboration with the ROG QA Team, a special Facility Questionnaire was developed for use by
non-EORTC participants in the CENTRIC study (Cilengitide).
The activities of the QA committee have been extended with the initiation of the intergroup RTOG-
EORTC study on glioblastoma. New members of the BTG wishing to participate in this study have
been site visited prior to the start of the study. Currently, for all BTG studies in which radiotherapy is
part of the treatment the Facility Questionnaire developed by the Radiation Oncology Group is used
to evaluate the RT installation of all participating centres. Furthermore, minimum RT requirements are
being defined for participation in BTG studies including dummy runs, all of which are overseen by the
EORTC Radiation Oncology Group with which the BTG closely collaborates.

Translational Research

In our randomized studies EORTC 26981/22981 and EORTC 26951, research on the identification of               87
molecular markers has been extremely important, and additional work is still ongoing. Gene expression
signatures associated with treatment resistance have been identified as independent prognostic
factors in GBM patients treated with TMZ/RT and identify patients who may benefit from other
additional treatment strategies. In another project it has been shown that immunohistochemistry for
the MGMT protein (alkyltransferase) does not identify GBM patients sensitive to chemo-irradiation
with temozolomide. A substantial inter-observer variation between pathologists on the diagnosis
of oligodendrogliomas has been demonstrated in the study in anaplastic oligodendroglial tumours,
and many of the tumours included in this study were observed to have molecular abnormalities one
expects to occur in GBM. A further evaluation of the WHO criteria for glioma is being planned. In
the randomized phase II study on erlotinib in GBM, the combined use of an extensive molecular
translational research program together with the two-arm design, prognostic and predictive EGFR-
related molecular features could be distinguished in recurrent GBM. In the low-grade glioma study
EORTC 22033/26033, loss of heterozygosity of chromosome 1p will be prospectively assessed. In all
our studies prospective tissue collection is part of the study.

Collaboration with other groups (EORTC and others)                                                           3. EORTC Current Research and Strategies

Within the EORTC, the BTG collaborates for most trials with the Radiation Oncology Group, and
here specifically with the ROG Quality Assurance Team. Ongoing successful collaborations exist also
with the Quality of Life Group aiming at developing improved tools allowing evaluation of the burden
of brain-cancer related symptoms, effect of treatment of symptoms but also toxicity, and finally quality
of life adjusted outcome measurements. Outside the EORTC, the Brain Tumour Group collaborates
with the NCI-C (Canada), Cancer UK (Medical Research Council; MRC), the US-based Radiation
Therapy Oncology Group (RTOG) and HUB (a brain tumour collaboration of ECOG, SWOG and
NCCTG) as well as the Neuro-Oncology Group of the NOA .
                                           Breast Cancer Group
                                           Structure of the Group

                                           Chair                                             T. Cufer, Golnik (SI)
                                           Secretary                                         D. Cameron, Leeds (UK)
                                           Treasurer                                         E. Rutgers, Amsterdam (NL)

                                           Steering Committee Members

                                           J. Bogaerts, Brussels (BE)
                                           H. Bonnefoi, Bordeaux (FR)
                                           E. Brain, Paris (FR) [Young Oncologist]
                                           D. Cameron, Leeds (UK)
                                           F. Cardoso, Brussels (BE)
                                           L. Cataliotti, Florence (IT)
                                           T. Cufer, Golnik (SI)
                                           L. Dal Lago, Brussels BE)
                                           S. Delaloge (FR)
                                           J. Jassem, Gdansk (PL)
                                           S. Marreaud, Brussels (BE)
                                           E. Rutgers, Amsterdam (NL)
                                           G. Van Tienhoven, Amsterdam (NL)
                                           H. Westenberg, Arnhem (NL)

                                           Recent Achievements

                                           The EORTC Breast Cancer Group (BCG) is a multidisciplinary group involving surgeons, medical
3. EORTC Current Research and Strategies

                                           oncologists, pathologists, radiation oncologists, basic scientists, and clinical research fellows. The main
                                           goal of the BCG is to carry high quality international clinical trials covering all areas of breast cancer
                                           care, from in situ carcinoma to metastatic disease, and to investigating new anticancer agents in phase
                                           I/II trials and therapeutic questions of strategic importance in large phase III trials.
                                           The BCG has recruited a total of over 23.000 patients in clinical trials, including an average of 1015
                                           patients/year over the last 3 years from 60 medical centres. These patients are included not only in
                                           EORTC-led studies, but also Inter-Group trials where the EORTC collaborates in trials led by other
                                           groups. The EORTC is one of the founding organizations of the Breast International Group (BIG), a
                                           worldwide network of breast cancer research groups. Intergroup collaboration is essential as it avoids
                                           duplication of efforts and wasting of resources.
                                           The BCG members meet twice a year. Additional teleconferences of the Steering Committee are held
                                           every 6 weeks.
Every two years, the group organises the ‘European Breast Cancer Conference’ (EBCC) in collaboration
with the European Society of Mastology (EUSOMA) and Europa Donna (the European Breast Cancer
Coalition). In March 2008, over 5000 participants from 92 countries attended a highly successful EBCC
6 held in Berlin. This meeting continued the tradition of previous conferences, providing excellent
opportunities for dialogue between clinicians, researchers, nurses and patients’ advocates. The aim
of these meetings is to create a platform for closer cooperation between the parties in order to
stimulate both scientific progress and to provide better standards of care for breast cancer in Europe
and beyond. The EBCC 7 will be held in Barcelona, in March 2010.
Over the past several years the EORTC has become increasingly more active in the field of translational
research. The BCG has incorporated translational research elements in their protocols. Translational
research evaluating correlations between clinical outcomes and biologic tumour characteristics has
become a high priority in the group’s strategy.
Examples of such trials are the EORTC 10094 trial and EORTC 10041 trials. The EORTC 10994 p53
trial, an inter-group translational research trial designed and led by the EORTC to assess the potential
predictive value of p53 status in patients with locally advanced/inflammatory or large operable breast
cancer. This trial prospectively randomised patients for a taxane vs. a non taxane regimen in the
neoadjuvant setting. The primary endpoint is progression free survival (PFS), and the secondary             89
endpoints are distant metastasis-free survival, overall survival, pathological complete response and
toxicity. This trial has an expected final analysis for the end of 2009.
The EORTC 10041 (MINDACT trial) is a multicentre, prospective, phase III trial which will accrue
6000 early breast cancer patients, either node negative or with 1-3 positive lymph nodes. It compares
the 70-prognostic signature, a genomic test developed with micro-array technology, to traditional
clinical-pathological methods for assessing the risk of breast cancer recurrence in women with early
breast cancer. It is hypothesized that using the genomic test in addition to traditional methods will
result in more accurate risk assessment such that in the future 10-20% of patients could safely avoid
adjuvant chemotherapy and its potential side effects. The MINDACT trial design also includes two
additional questions related to the best treatment in terms of adjuvant chemotherapy and hormone
therapy. The MINDACT trial already reached its first milestone, the “pilot phase” consisting of the
first 800 patients, in November 2008. The preliminary results of this phase demonstrate that the trial
is logistically feasible, that the compliance rate of both physicians and patients is high, and that the

                                                                                                            3. EORTC Current Research and Strategies
overall process provides good quality data and biological materials. With an average accrual rate of
120 patients per month, the trial is expected to finish recruitment by the end of 2012.
The EORTC trial 10981-22023 AMAROS (After Mapping of the Axilla: Radiotherapy Or Surgery) is a
phase III study comparing a complete axillary lymph node dissection with radiotherapy to the axilla in
sentinel node positive patients, with sentinel node negative patients given no further axillary treatment
but still being followed for the end-points of the study. Patients included have operable invasive
breast cancer greater than 5mm and less than 5 cm without clinically compromised regional lymph
nodes. The main objective of the trial is to provide equivalent local/regional control for patients with
proven axillary lymph node metastasis, as detected by sentinel node biopsy, with reduced morbidity
by treating with axillary radiotherapy instead of axillary lymph node dissection. The study accrued
approximately 4000 patients by the end of 2008. Hence, 85% of the required patients are included, and
the trial is expected to finalize the accrual of patients in 2010. A new EORTC trial is planned, which
will succeed the AMAROS trial.
                                           This is the POWER trial, POsitive Sentinel node: Wait & see, Excision or Radiotherapy The aim of
                                           this trial is to analyze the axillary recurrence rate in patients with proven (sub) micrometastases by
                                           sentinel node biopsy if no further axillary therapy is offered.
                                           The EORTC trial 22051 (SUPREMO -Selective use of postoperative radiotherapy after mastectomy)
                                           is an InterGroup trial, designed to determine the effect of ipsilateral chest wall irradiation following
                                           mastectomy and axillary clearance for women with operable breast cancer at ‘intermediate risk’ of
                                           loco-regional recurrence. The primary endpoint is overall survival and chest wall recurrence. The
                                           number of patients required is 3700, and the current accrual is about 500 patients. Accrual to date has
                                           been slower than anticipated, so that an amendment is planned to enlarge the eligibility criteria. This
                                           will extend enrolment to patients with clinical stage T3N0 or T1-2 N0-1 or T1-2 N0 with additional
                                           risk factors, patients who have received neoadjuvant systemic therapy, patients carrying BRCA 1 or
                                           2 gene mutations, patients with histologically positive internal mammary sentinel nodes, and patients
                                           with pN1 in whom less than 10 lymph nodes were obtained on an axillary clearance. This study
                                           prospectively studies the cardiac toxicity of the radiotherapy, and collects tumour samples in order
                                           to be able to study biological characteristics of those tumours that do and don’t recur, both with and
                                           without radiotherapy.
          90                               The EORTC 10054 study (Lapatax) is a phase I/II trial designed to compare the use of Lapatinib,
                                           Herceptin and the combination when given in conjunction with Docetaxel during FEC-D neoadjuvant
                                           chemotherapy for large operable and locally advanced breast cancer. The phase I part of the study,
                                           which determines the recommended doses of Lapatinib and Docetaxel, is expected to close by
                                           the summer, 2009, and the 150-patient phase II randomised three-arm study will then open in the
                                           autumn, 2009. This study has already demonstrated that it is possible to combine the licensed dose
                                           of docetaxel (100mg/m2) with Lapatinib, something not found possible in advanced cancer patients.
                                           The study also involves prospective tumour and blood sample collection to provide a resource for
                                           translational research.
                                           The EORTC 10071 ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study
                                           is another InterGroup trial. It is a randomised, open label multi-centre phase III study comparing
                                           the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib
                                           versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2
                                           over expressing and/or amplified breast cancer. The study also has a strong translational research
3. EORTC Current Research and Strategies


                                           Translational Research

                                           In order to make best use of the limited available tissue, for the EORTC 10094 trial (p53 study) the
                                           BCG created a group named TransTGIF which is mainly involved in the development of sub-studies
                                           using the material collected in the context of this trial. A TMA construct (tissue microarray) including
                                           more than 1000 non-frozen samples will be completed by the end of July 2009. This group has a
                                           steering and executive committee that evaluate all the sub-study proposals.
However, the group has already published 3 papers on the translational research that has been
conducted, and has identified a new sub-type of breast cancer (molecular apocrine) thereby providing
the first evidence in breast cancer that a gene-signature can predict differential response between
therapies, and further evidence that stromal gene expression patterns are predictive of chemotherapy
resistance (Identification of molecular apocrine breast tumors by microarray analysis, Oncogene, 2005;
Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy:
a sub study of the EORTC 10094/BIG00-1 clinical trial, Lancet Oncol, 2007; A stroma-related gene
signature predicts resistance to neoadjuvant chemotherapy in breast cancer, Nature Medicine, 2009)
and also has other different projects in preparation. Additional studies are ongoing with grant support
from a 2008 STRAT-EGAM award.
In the EORTC 10041 (MINDACT trial) mandatory fresh tumour samples for microarray analysis are
stored for biobank and proteomic analysis. Also the representative paraffin tissue block has to be sent
for central histopathology review and for the production of tissue microarrays; optional blood sample
collection may be performed for genetics and proteomics and for future research projects.
Prospective frozen tumour and blood samples are being collected in the phase I/II EORTC 10054
(Lapatax) study. It is expected that the pharmacokinetic profiles will be available, along with preliminary
translational tumour analyses, by the end of 2009.                                                            91

Projects / Strategies for the coming years

1. Transversal collaboration within the EORTC

We believe that the opportunity to develop a trial using the expertise of different EORTC groups is
unique to the EORTC.The examples of successful transversal collaboration within EORTC can be seen
in the AMAROS trial. However, such transversal collaboration is not always easy, and we believe that
EGAM meetings will further enforce such a collaboration through NOCI and broader. One future trial
is planned to evaluate sunitinib and radiotherapy in the treatment of brain metastasis, involving the
collaboration of the EORTC Breast Cancer, Brain Tumour, and Radiation Oncology groups. Another

                                                                                                              3. EORTC Current Research and Strategies
initiative is the development of specific trials for the elderly populations in collaboration with the
Cancer in the Elderly Task Force. Two programs are currently in discussion: (i) a randomized phase
II study of single agent capecitabine versus capecitabine-AMG-386 doublet as first line treatment in
elderly (≥70) breast cancer patients (primary endpoint PFS, trial endorsed by the Executive Committee);
(ii) a randomized phase II trial of trastuzumab-DM1 (T-DM1) versus capecitabine + trastuzumab as
first line chemotherapy in elderly patients with metastatic Her2 positive breast cancer.
                                           2. Translational research

                                           In addition to the many translational research trials mentioned in the previous section, we would like
                                           to add the EORTC 90091-10093trial which will be activated soon. This pilot trial will be investigating
                                           whether the elimination of HER-2 positive circulating tumour cells (CTCs) with trastuzumab would
                                           result in improved disease free survival in patients with early HER-2 negative breast cancer. In the
                                           event that the effect is found significant, a randomized trial will follow to prospectively validate this
                                           approach on disease free survival.

                                           3. Collaboration with national and international groups

                                           The BCG has a long track record of collaborations with national or international groups which
                                           fits perfectly with the EORTC strategic plan. The expertise of EORTC Headquarters in the field of
                                           legal and regulatory issues is highly respected, and this should be considered as a strength in the
                                           context of efficient international collaboration. The MINDACT trial is an excellent example of such
          92                               a collaboration.
                                           Other examples of intergroup trials (recently closed, ongoing or under discussion) are: SUPREMO
                                           (MRC), SOFT and SOLE trials (IBCSG), ALTTO (BIG), DCIS trial (TROG).
                                           In addition we would like to mention two additional examples:
                                           • Male Breast Cancer (BC) International Registration and Biological Characterization Program

                                            (EORTC 10085 Intergroup study). Collaboration with BIG and SWOG is foreseen in this project.
                                           • Discussion is underway about the EORTC contributing to the UK randomized trials of

                                            Carboplatin vs. Docetaxel in Triple Negative and/or BRCA-mutant cancers.

                                           4. Encouraging young oncologists

                                           The EORTC is deeply involved with medical education. The BCG has an active fellowship program,
                                           where young physicians are trained and work on group projects either at EORTC Headquarters,
3. EORTC Current Research and Strategies

                                           where they participate on setting up and conducting clinical trials, or at active institutions, where they
                                           conduct clinical and translational research projects. During 2008, BCG twice allocated 10 grants to
                                           enable young Oncologists to attend the semi-annual group meetings, and we plan to continue to do
                                           this in 2009 and 2010. In this way the BCG hopes to encourage younger Oncologists to recruit into
                                           and develop further studies to be run by the group.
Children's Leukemia Group
Children’s Leukaemia Group
Structure of the Group

Chair                                          Y. Benoit, Ghent (BE)
Secretary                                      Y. Bertrand, Lyon (FR)
Treasurer                                      P. Lutz, Strasbourg (FR)
The group meetings are held twice a year and the Children’s Leukaemia Group (CLG) comprises 25
paediatric centres in Belgium, France and Portugal.
Young Oncologists / Scientists                 B. De Moerloose, Gent (BE)
                                               G. Plat, Toulouse (FR)

Open studies

EORTC study 58051: International collaborative treatment protocol for infants under one year with
acute lymphoblastic or biphenotypic leukaemia. The CLG is participating in the large intergroup
INTERFANT -2006 study for children less than 1 year of age. The study is presently open to patient’s
entry for centres in Belgium and soon will include participation from centres in France and Portugal.

Studies in development

EORTC 58081 study: Translational research - observational study for identification of new possible
prognostic factors and future therapeutic targets in children with acute lymphoblastic leukaemia
This is an observational study with collection of patient data and parallel collection and analysis of
biological samples (BM, PB).
The main study objective is to organize and perform biobanking using standardized procedures

                                                                                                         3. EORTC Current Research and Strategies
adapted to new technologies (microarrays, proteomics etc.) in a prospective cohort of patients with
ALL in parallel with collection of relevant patient clinical data.
This biobank will give us the opportunity to perform translational studies with the following aims:
Identify leukaemia cell genetic abnormalities (e.g. mutations in T-ALL, miRNA’s in B-lineage ALL)
associated with leukemogenesis. How they associate, how they determine clinical presentation and
prognosis of children.
Identify and explore molecular pathways affected by these genetic lesions in order to identify future
therapeutic targets.
Identify patient polymorphisms impacting individual response to drugs and investigate their prognostic
The project was endorsed by EORTC Executive Committee in December 2008.
                                           Recently closed study

                                           EORTC study 58951: Dexamethasone vs. prednisolone during induction and maintenance therapy,
                                           prolonged vs. conventional duration of L-Asparaginase therapy during consolidation and late
                                           intensification, in ALL and NHL of childhood. A Randomised phase III study
                                           The study objectives were:
                                           1) to assess the value of dexamethasone vs. prednisolone administered during induction regarding the
                                           EFS and Survival in children with ALL and with NHL;
                                           2) to assess the value of the Increase of the number of administrations of L-Asparaginase during
                                           consolidation (protocol I) and during the late intensification (protocol II) regarding the DFS and
                                           Survival in patients without VHR features;
                                           3) to assess the value of VCR+corticosteroid pulses administered during maintenance therapy
                                           regarding the DFS and Survival in patients with average risk characteristics. This third Randomisation
                                           is now closed (part of an international study).
          94                               The study was closed to accrual in August 2008, with a total of 2067 patients entered over a 10 year
                                           period (December 1998 until August 2008).
                                           Interim results are to be published following the interim analysis and IDMC recommendations. An
                                           oral presentation already was given at ASH 2008.

                                           Projects / Strategies for the next years

                                           A common protocol for newly diagnosed ALL is expected for the EORTC group and the French
                                           FRALLE group. The next study could be discussed with the members of the I-BFM study group in
                                           order to have common stratification procedures.
                                           Discussions are ongoing concerning the VHR patient to more accurately define the indications for
                                           hematopoietic stem cell transplantation and to evaluate new therapies for patients with a poor
3. EORTC Current Research and Strategies

                                           The main problem concerns first-line ALL therapy. Good results are obtained with an EFS at five years
                                           above 80% in all of the more recently reported studies. For some categories of patients (i.e. high
                                           hyperdiploidy, patients with translocation t (12, 21): nearly 50% of patients with B-cell ALL) the results
                                           are even better with an EFS above 90%. The goal of an international study is to try to obtain a very
                                           comparable stratification of patients and to focus on certain kinds of patients with poor prognoses
                                           in order to have a common therapeutic approach (i.e., non-remission after induction therapy, patients
                                           with high level of MRD, MLL rearrangement).
                                           Is it really justified to perform randomised studies for patients with very good prognoses, with late
                                           events, and with a high risk of ultimately not being able to answer the questions asked?
It would be more useful to have a good registry for such patients and to concentrate our efforts on
the biological characteristics of the disease and the patient, particularly concerning the toxicity of the
drugs (pharmacogenomics).
The randomised trials could be restricted to patients with a more dismal prognosis (other B cell
leukaemias and T cell leukaemias).
The other malignant diseases are very rare in paediatric haematology, and international collaboration
is mandatory to address interesting questions.
A new ALL relapse protocol, with three arms, is being discussed in close cooperation with other
European groups (Germany, United Kingdom).
An international protocol for paediatric patients with Non Hodgkin lymphoblastic lymphomas is open
since 2005, coordinated by the German group (A. Reiter, M. Zimmerman).

Translational Research
The biobanking project (EORTC 58081 study) is presently under scientific review by the EORTC PRC.
The project is planned to start in 2009.
The plan is to create a registry of patients that are treated according to common recommendations
and to collect relevant clinical data for these patients. All registered patients should have their samples
collected and analysed according to a well defined translational research strategy (6 TR projects). This
would help in identifying specific subgroups of patients, with different prognoses, and identify new
treatment targets.

Collaboration with other groups

The Group has contact with the International BFM Study group and has been involved in prospective
studies in ALL protocols (value of pulses of VCR + dexamethasone during maintenance therapy).

                                                                                                              3. EORTC Current Research and Strategies
There is also close collaboration with the Ponte di Legno Group involved in the treatment of ALL
(collaborative international studies, i.e. (t(4;11), t(9;22), t(1;19), hypodiploidies non-responders to the
induction therapy, second malignancies, patients with Down syndrome).
A first international protocol for the treatment of ALL in infants was activated in 1999 (INTERFANT
Chairman R Pieters) and the members of the CLG have contributed to this trial.
A second protocol Interfant 06 is ongoing and EORTC CLG is also participating.
There is also a European trial for patients with refractory or relapsed AML evaluating the value of
daunoxome in association with fludarabine, cytarabine and G-CSF.
Collaboration with the French group FRALLE is ongoing to evaluate the possibility of a common trial:
next trial for first line therapy in ALL.
                                           Gastrointestinal Tract Cancer
                                           GastrointestinalTract Cancer Group
                                           Structure of the Group

                                           Chair                                          M. Lutz, Saarbrucken (DE)
                                           Secretary                                      M. Ducreux, Villejuif (FR)
                                           Treasurer                                      T. Ruers, Amsterdam (NL)

                                           Task Force Chairs

                                           Colorectal                                     G. Folprecht, Dresden (DE)
                                                                                          M. Peeters, Gent (BE)
                                           Pancreatic                                     J-L. Van Laethem, Brussels (BE)
                                           Imaging                                        F. Lordick, Muenchen (DE)
                                                                                          T. Ruers, Amsterdam (NL)
                                           Hepatocellular Carcinoma                       A. Hendlisz, Brussels (BE)
                                           Translational Research                         D. Aust, Dresden (DE)
                                           Stomach                                        F. Lordick, Muenchen (DE)
                                                                                          A. Roth, Geneva (CH)
                                           Newsletter                                     E. Mitry, Boulogne-Billancourt (FR)
                                           Quality Control                                T. Conroy, Vandoeuvre-Les-Nancy (FR)
                                           Other Board Members                            T. Conroy, Vandoeuvre-Les-Nancy (FR)
                                                                                          D. Arnold, Halle (DE)
                                                                                          C.-H. Köhne, Oldenburg (DE)
                                                                                          E. Mitry, Boulogne-Bilancourt (FR)
                                                                                          B. Nordlinger, Boulogne-Bilancourt (FR)
                                                                                          I. Popov, Belgrade (RS)
                                                                                          C. Schuhmacher, Muenchen (DE)
                                           Young Oncologist                               G. Folprecht, Dresden (DE)
3. EORTC Current Research and Strategies

                                           Recent Achievements

                                           1. Colorectal cancer

                                           A new study of perioperative chemoradiotherapy in locally advanced rectal cancer, PETACC-6 (40054-
                                           22026), opened in 2008 with an accrual goal of approximately 1100 patients. In addition to the strong
                                           translational research components in all active protocols, past projects such as PETACC-2 (40963)
                                           and PETACC-3 are proving to be a rich source of translational research material.
Adjuvant studies: The largest (more than 2000 patients) active trial in the group is an intergroup
collaboration within the PETACC framework, PETACC-8, which is coordinated by the FFCD. This
study compares adjuvant treatment of completely resected colon cancer with FOLFOX4 versus
FOLFOX4 plus cetuximab.
Final results of PETACC-1 were published in the European Journal of Cancer in 2008. This trial,
which was a comparison of raltitrexed versus leucovorin-modulated 5-FU in resected Dukes C
colorectal cancer, had enrolled 1921 patients at the time of its early closure in 1999. It was a result
of collaboration with national groups from Canada, Egypt, France, Germany, Italy, Portugal, Spain, The
Netherlands and the UK.
Final results of the PETACCC-3 trial were published in the Journal of Clinical Oncology in 2009.
Advanced disease:The BOS (Biologicals-Oxaliplatin-Surgery) trial, a randomised phase II trial evaluating
the feasibility and tolerance of the combination of FOLFOX with cetuximab and the combination of
FOLFOX with cetuximab and bevacizumab as perioperative treatment in patients with resectable liver
metastases from colorectal cancer, was closed prematurely in 2008 due to toxicity.
The EPOC (European Peri-Operative Colon) study, EORTC 40983, examined the benefit of
perioperative chemotherapy for patients with initially resectable liver-only metastases from colorectal    97
cancer and arrived at the practice-altering conclusion that perioperative FOLFOX4 chemotherapy is
safe and reduces the risk of PFS events by approximately 25% over surgery alone in these patients.
The final results for EORTC 40015 were published in 2007 (Annals of Oncology, 2007). The study
aimed to demonstrate the noninferiority of capecitabine to 5-fluorouracil (5-FU)/folinic acid (FA), in
relation to progression-free survival (PFS) after first-line treatment of metastatic colorectal cancer
and the benefit of adding celecoxib (C) to irinotecan/fluoropyrimidine regimens compared with
placebo (P). Because the study was terminated at an early point with a small sample, it was not able to
provide specific conclusions in relation to the noninferiority of CAPIRI compared with FOLFIRI.
Safety results for the CLOCC trial, 40004, were submitted as an abstract. This randomised phase III
study of local treatment of liver metastases by radiofrequency combined with chemotherapy versus
chemotherapy alone in patients with unresectable colorectal liver metastases was activated in 2002
and closed in 2007 after enrolment of 119 patients.

                                                                                                           3. EORTC Current Research and Strategies
2. Pancreatic cancer

The first part of a randomised phase II/III study comparing gemcitabine followed by gemcitabine plus
concomitant radiation (50.4 Gy) versus gemcitabine alone after curative pancreaticoduodenectomy
for pancreatic head cancer was concluded and analysed in 2007, and an update on survival data was
completed in 2009. Publication of these results is in preparation. The phase III component of this
study will not start.
                                           3. Gastric cancer

                                           The GI Group Gastric Cancer task force published its guidelines for treatment of gastric cancer in the
                                           December 2007 edition of the European Journal of Oncology.

                                           4. Imaging in GI Cancers

                                           The EORTC GI and Radiation Oncology groups held a joint meeting on the role of PET imaging in GI
                                           cancer in Heidelberg. Imaging is expected to play a larger role across disease types, particularly the
                                           use of earlier imaging to direct therapy, and the use of functional imaging as a surrogate endpoint for
                                           drug effectiveness and disease response.

                                           5. Anal Cancer

          98                               The 22011-40014 phase II-III trial of continuous fluorouracil plus mitomycin C versus mitomycin C
                                           plus Cisplatin as chemotherapy combination in combined radiochemotherapy for locally advanced
                                           anal cancer was closed in 2007, after recruitment of 88 patients. This trial was coordinated by the
                                           EORTC Radiation Oncology Group.

                                           Projects / Strategies for the next years

                                           The group has made an effort to harmonise its strategy with that of EORTC as a whole, targeting both
                                           large phase III projects that have the potential to change practice, as well as smaller trials which take
                                           advantage of the EORTC’s strengths in terms of TR expertise and ability to reach adequate numbers
                                           for niche diseases. While the group is interested in working with new, up and coming compounds, for
                                           practical reasons, this is often proposed as late Phase II or combined II/III projects.
                                           To generate new ideas, the GI group has established a number of task forces: colorectal, gastric, imaging,
3. EORTC Current Research and Strategies

                                           pancreatic, hepatocellular carcinoma, and anal. Each has met in the past year and have presented to
                                           the GI group as a whole at group meetings. The most active taskforce has been the colorectal one, its
                                           most prominent success in the last year being the presentation by Dr. Nordlinger on the results of
                                           the 40983 trial at a plenary session of the 2007 ASCO annual meeting.
                                           The CRC taskforce is now developing the protocol for the EORTC 40091 trial to succeed the EORTC
                                           40051 BOS trial.
                                           The gastric taskforce meetings of the last year yielded the lapatinib study, which was recently approved
                                           by the Executive Committee. The imaging task force was responsible for a successful, multidisciplinary
                                           meeting on gastric imaging held this fall in Heidelberg. In addition to specific proposals related to
                                           functional imaging (PET, fMRI) and early look CT, some of their ideas have been incorporated into
                                           proposals from other task forces as well.
To date, because of their scale and prevalence, colorectal projects have dominated the group. This also
reflects the research interests of the group leadership, so it is important that the other task forces
be supported in bring their project concepts forward. The EORTC Headquarters, via the Clinical
Research Physician, statistician and EPOD can play a role. Project concepts from the pancreatic, HCC
and anal task forces were discussed at the most recent group meeting, but were not yet adequately
mature for an ePOD submission.

Translational Research

The group has a strong core of translational researchers who bring a breadth of expertise to the GI
Group projects. The GI Group is working closely with the virtual tumour bank.
Wherever possible, the GI group has sought to leverage its earlier large trials for TR. At the most
recent group meeting, for example, Daniela Aust presented progress regarding the TR programme for
the PETACC-2 protocol, which opened in 1999 and closed to accrual in 2004. This was a randomised
phase III intergroup trial of high-dose infusional 5-FU versus standard bolus 5-FU/FA. In this project,
tissue microarrays have been prepared on 650 cases, with DNA extraction in 300, and 300 slides sent       99
to the virtual tumour bank. In the next year, RNA analysis will begin. At this meeting, six researchers
presented further proposals for these biological materials including pharmacogenomic studies,
transcriptome pathway analysis, analysis of CIN and MIS status, and analyses by methods including
IHC, FISH, and SNP arrays. Similarly, the PETACC-3 protocol (described above) is being analysed
in terms of several markers including MSI, Kras, SMAD4, TS, and p53. SNP analysis, which was not
informative in homozygous patients for methodological reasons, is being repeated by CGH. As the
results from this study mature, these marker findings are expected to become more predictive.
Histopathological analysis was performed on the tissue from liver metastases of colorectal cancer in
the EPOC protocol (described above).
The expertise and operational procedures developed in each of these trials have contributed to an
impressive TR repertoire, which is being utilized in present studies such as the BOS protocol. The
ongoing PETACC-8 trial also includes an ambitious translational research programme including DNA
analysis for LOH, mitochondrial mutations, SNP of metabolizing enzymes, and establishes tissue arrays

                                                                                                          3. EORTC Current Research and Strategies
for analysis of EGF-R homo- and heterodimer formation.

Collaboration with the other groups

The EORTC GI Group has an intergroup collaboration with national groups in the framework of
the PETACC (Pan-European Trials in Alimentary Tract Cancer) structure, and is presently developing
PETACC-9. Collaborations are also ongoing with other EORTC Groups, such as the EORTC Radiation
Oncology and the Quality of Life Groups, the EORTC Elderly Task Force, and the PathoBiology
                                           Genito-Urinary Tract Cancer
                                           Genito-Urinary Tract Cancer Group
                                           Structure of the Group

                                           Chair                                          S. Osanto, Leiden (NL)
                                           Secretary                                      H. Kynaston, Cardiff (UK)
                                           Treasurer                                      H. van Poppel, Leuven (BE)

                                           Disease-Oriented Committees

                                           The work of the EORTC Genito-Urinary Tract Cancer (GU) Group is planned by the Disease-
                                           Oriented Committees, i.e. prostate, non-muscle invasive bladder cancer, advanced bladder cancer,
                                           renal cell cancer, testicular cancer, and the quality control committee. These committees are
                                           responsible for discussing new ideas and preparing new protocols for consideration by the group’s
100                                        Executive Committee and the Scientific Board, which includes the Chairs of all the committees and
                                           representatives of EORTC Headquarters.

                                           Chairs of the five Disease-Oriented Committees and the Quality Control Committee:

                                           Prostate cancer committee                      N. Clarke, Manchester (UK)
                                           Non-muscle invasive bladder cancer             F. Witjes, Nijmegen (NL)
                                           Advanced bladder cancer                        J. Bellmunt, Barcelona (ES)
                                                                                          P. Albers, Dusseldorf (DE)
                                           Renal cell cancer                              P. Mulders, Nijmegen (NL)
                                           Testicular cancer                              G. Daugaard, Copenhagen (DE)
                                           Quality control                                J. Oddens, Den Bosch (NL)
                                           Young Oncologist                               T. Powles, London (UK)
3. EORTC Current Research and Strategies

                                           Recent Achievements

                                           Muscle invasive bladder carcinoma
                                           The GU Group has successfully finished the muscle invasive bladder carcinoma study which investigated
                                           a triplet versus standard doublet chemotherapeutic regimen (EORTC 30987). The study showed that
                                           the triplet was well tolerated but did not add to the standard chemotherapy regimen in terms of
                                           better outcome indicating that the implementation of novel targeted drugs needs to be considered
                                           in order to improve the outcome of metastatic bladder carcinoma patients. A translational research
                                           project will investigate the predictive value of expression of ERCC1 and other DNA-repair related
                                           enzymes with respect to differential chemosensitivity to Cisplatin/Gemcitabine +/- Paclitaxel.
For metastatic patients with poor renal function another triplet chemotherapy substituting the
nephrotoxic cisplatin with carboplatin (Carboplatin, Vinblastine and Methotrexate) was compared
with a doublet (Carboplatin plus Gemcitabine) in trial 30986 (manuscript phase II part of the study
accepted in JCO).

Renal Cell carcinoma
The Interferon-alpha, IL-2 plus 5-FU study, the EORTC 30012 trial conducted together with the MRC,
was closed, and a manuscript has been submitted for publication.

Testicular cancer
Two major trials have been performed in testicular cancer: the aim of one of these trials is to
investigate the role of intensified, high-dose chemotherapy in patients with a poor prognosis; the
other trial is a unique worldwide trial in which the addition of Taxol to the standard regimen BEP
(bleomycin, etoposide, cisplatin) is investigated in intermediate risk patients.

Ongoing and Future Trials

Prostate carcinoma
A new study has started recruiting as a follow-up to the EORTC 22911 trial, where adjuvant
radiotherapy was compared to radiotherapy alone in patients with pT3 disease. This new study, the
EORTC 30041-22043 phase III trial, will look at adjuvant radiotherapy with or without 6 months
of hormonal therapy in prostate carcinoma patients with positive surgical margins following radical
prostatectomy. The study will once again be conducted in collaboration with the EORTC Radiation
Oncology Group.
EORTC 30985 trial, an intergroup phase III study with SWOG 9346 trial, which studies intermittent
androgen deprivation in patients with stage D2 prostate cancer, has nearly reached the required
number of patients.

                                                                                                      3. EORTC Current Research and Strategies
The Committee is also exploring the combination of bicalutamide +/- an IGF-1R inhibitor in patients
failing treatment with an LHRH analogue and have a rising PSA.
Another project to be explored is the optimal treatment for patients with pN+ disease to which end
a close collaboration with the Radiation Oncology Group will be initiated.

Bladder carcinoma
At present there are no new studies in non-muscle invasive bladder cancer (NMIBC), but evaluation
of closed studies is ongoing and several manuscripts are in preparation.
A quality control study is in preparation (EORTC 30082) and collaboration with the European
Association of Urology is sought.
                                           In a phase I study the standard chemotherapy regimen +/- lapatinib, a dual Her-1 and Her-2 blocker is
                                           being investigated to determine whether the addition of a novel targeted agent will contribute to the
                                           outcome of advanced bladder cancer patients (EORTC protocol 30061).
                                           Another study, which investigates the additional role of sorafenib when added to standard chemotherapy,
                                           is inpreparation (EORTC 30071).

                                           Renal Cell carcinoma
                                           A new study that has been approved (in The Netherlands, Belgium and Italy) is the joint MRC/EORTC
                                           SORCE trial (EORTC 30072) which investigates the role of adjuvant treatment with sorafenib in
                                           intermediate and high risk patients.
                                           Another study which will soon start recruiting is a randomized phase III trial assessing the timing
                                           of radical nephrectomy in patients with synchronous metastatic renal cell carcinoma (EORTC
                                           30073: presurgical sunitinib followed by nephrectomy and sunitinib versus nephrectomy followed by
                                           Projects / Strategies for the coming years

                                           The EORTC GU Group aims at strengthening the network of clinicians from many disciplines
                                           including urologists, medical oncologists, and radiation oncologists, enhancing the contribution of
                                           pathologists, radiologists, epidemiologists, as well as basic scientists, to fully exploit the potential of a
                                           multidisciplinary Group dedicated to uro-oncology. The Group’s objectives over the next two years
                                           will be to expand its portfolio of clinical trials intended to change clinical practice. Key elements to
                                           the success of the Group will be the integration of and close collaboration with basic scientists to
                                           enhance communication and the ability to formulate the right questions to be tested in new clinical

                                           Cancer survivorship
3. EORTC Current Research and Strategies

                                           The EORTC QOL and the EORTC GU Group are pursuing a joint cross-cultural cancer survivorship
                                           research project focusing on both testicular and prostate cancers. The study represents a first step
                                           toward developing a large scale cancer survivorship research program within the EORTC. This
                                           research program would be unique in the world, in that the international context with its ethnic
                                           and cultural diversity in which the EORTC operates, facilitates the investigation of cross-cultural
                                           differences in the health-related quality of life of cancer survivors. The aim of the study is to establish
                                           appropriate and workable procedures for identifying and recruiting survivors from two EORTC GU
                                           trials and to collect and analyze questionnaire data from the two survivorship samples in order to
                                           generate psychometric data for questionnaires SF-36, the QLQ-C30 and the IOC.
Essential to carrying out translational research is the sharing of patients’ tissues, the presence of
adequate collection of tissues, and a full clinical dataset. In relation to already performed or ongoing
studies, tissue collections will be arranged in order to identify prognostic and predictive factors and
biomarkers with great clinical utility. Emphasis will be put on the prospective collection of malignant
and normal tissue from patients entering EORTC trials to investigate critical molecular pathways
associated with tumour progression and metastasis and assessment of molecular determinants of
treatment efficacy. Expression profiles will require validation in independent sets to identify subsets
of patients who may benefit from tailored treatment.

Attracting Young Oncologists / Scientists
A key to the success of the Group in the coming years will be the involvement of more young
investigators. The GU Group will actively pursue the identification of promising young oncologists,
give them the opportunity to present their ongoing research at the bi-annual meetings. Already, various
initiatives have been taken by younger member oncologists, e.g. with the support of the Group, a
translational research grant was obtained from the EORTC which will help to exploit the clinical           103
utility of MRI in prostate cancer patients (B. Tombal). Similarly, the role of surgery and radiotherapy
will be further explored by two other young members.

Brainstorming sessions
In order to indentify the key issues and develop new trials, open brainstorming meetings held by the
various Disease Committees and their subgroups are encouraged.

Visibility of the GU Group
Contributions to international meetings will be actively pursued. The long-standing contribution to
the annual EAU Congress will be broadened and further international activities at various global
meetings will be actively explored. Furthermore, the Group will invest in publicising the start of each

                                                                                                           3. EORTC Current Research and Strategies
new trial in the various countries to enhance awareness. Recent meetings have been well attended
and new members have been attracted indicating the Group’s good spirit and great enthusiasm.

Translational Research

Functional Imaging
In prostate cancer, for instance, there is a clear need to develop ways of measuring metastatic spread
to the bone in high risk patients in relatively early stages of the disease as well as better measuring
responses in more advanced disease through, for example, developing and validating skeletal MRI
imaging and by identifying bone and other biomarkers.
                                           Translational research grant
                                           The EORTC GU Group was awarded a grant from EORTC Board for a project studying skeletal MR
                                           imaging in patients with prostate cancer (EORTC protocol 30081). This project will study the role of
                                           axial skeletal MRI compared to traditional bone scan in evaluating patients with prostate cancer and
                                           assess if this imaging modality can be used for modifying RECIST to determine response to treatment.
                                           This project will possibly be linked to the study in patients failing LHRH therapy.

                                           Collaboration with other Groups (EORTC and others)

                                           Other EORTC Groups
                                           The long-standing successful collaboration with the Radiation Oncology Group will be continued in
                                           yet another large trial in prostate cancer patients (EORTC 30041-22034, M. Bolla and H. van Poppel
                                           are the principal investigators).

                                           Medical Research Council (MRC) and other global Cooperative Groups
                                           The existing close collaboration with the MRC will be continued (SORCE trial). Recent contacts
                                           with members of SWOG (Southwest Oncology Group) may mark increased close collaboration with
                                           that Group. Collaboration with other international Groups will be explored to develop a stronger
                                           intergroup network which will be in a better position to explore the efficacy of new forms of
                                           treatment in rarer uro-oncological diseases in a more rapid manner in keeping with the new era.
                                           Ways to implement a fast track system for approving and quickly setting up pharma-sponsored trials
                                           will be further explored.

                                           European Association of Urology (EAU)
                                           Collaboration with other clinical research groups within Europe such as with the EAU is also being
                                           explored. There is already a link between the GU Group and the EAU (affiliated membership and
                                           presentation of GU Group data during the annual EAU Congress) and collaboration with the EAU
3. EORTC Current Research and Strategies

                                           Research Foundation would enhance this connection and facilitate the exploration of possible joint

                                           Herbert Irving Comprehensive Cancer Center
                                           Recently the Group has started to explore a close collaboration with the Herbert Irving Comprehensive
                                           Cancer Center in New York (Prof. C. Cordon-Cardo) aimed at studies in both prostate and renal
                                           cancer. In prostate cancer, collaboration will focus on the validation of early studies on the predictive
                                           accuracy of the “systems pathology” approach which will be instrumental in designing novel future
Gynaecological Cancer Group
Structure of the Group

Chair                                             A. Casado-Herraez, Madrid (ES)
Secretary                                         D. Katsaros, Torino (IT)
Treasurer                                         I. Vergote, Leuven (BE)

Executive Steering Group

A. Casado-Herraez, Madrid (ES)
N. Reed, Glasgow (UK)
D. Katsaros, Torino (IT)
I. Vergote, Leuven (BE)
N. Siddiqui, GLasgow (UK)
F. Amant, Leuven (BE)
Translational Research                            E. Berns, Rotterdam (NL)
Young Oncologist                                  A. Jimeno, Madrid (ES)

Tumour Site Committees and other committees

Cervix and Vulva                                  N. Siddiqui, Glasgow (UK)
Endometrium                                       F. Amant, Leuven (BE)
Ovary                                             D. Katsaros, Torino (IT)
Translational Research                            E. Berns, Rotterdam (NL)
                                                  M.E.L. van der Burg, Rotterdam (NL)
Quality control                                   P.B. Ottevanger, Nijmegen (NL)
Quality of life                                   E. Greimel, Graz (AT)

                                                                                                              3. EORTC Current Research and Strategies
Surgery                                           F. Mota, Coimbra (PT)
Radiation                                         E. van der Steen, Arnhem (NL)
Chemotherapy                                      P.B. Ottevanger, Nijmegen (NL)


The Gynaecological Cancer Group (GCG) is a multi disciplinary clinical disease orientated group
composed of Gynaecological Oncologists, Clinical/Medical Oncologists, Radiation Oncologists and
Pathologists together with a number of Data Managers/Trial Co-ordinators and Nurses. The group
has a strong past portfolio of Clinical Trials which have influenced international clinical practice mainly
in ovarian cancer and in the 1980’s and 1990’s in some of the rarer tumours.
                                           The last 5 years have seen some significant changes primarily as a result of the European Union
                                           Clinical Trials Directive which has had a major impact on the delivery of Clinical Trials. Simultaneously
                                           we have seen the rise and development of National Co-operative Groups. One of the strengths of the
                                           EORTC GCG was that it brought together all the different pan-European organisations.

                                           Recent Achievements

                                           One study currently open to patient entry, the EORTC 55994 trial, is investigating the role of
                                           neoadjuvant chemotherapy followed by radical hysterectomy and lymph node dissection versus
                                           concomitant chemo/radiation in early/intermediate cervical cancer. This important study has had a
                                           bit of a chequered history, but it is continuing to recruit steadily and has the potential to significantly
                                           impact future practice internationally. This Study is now approaching 500 patients out of the planned
                                           686. At present the gold standard of treatment remains concomitant chemo/radiation, and the results
                                           of this Trial will be awaited with considerable expectation.
                                           The year 2008 saw the closure of the first large trial (EORTC 55041) comparing standard chemotherapy
106                                        versus combination chemotherapy and maintenance erlotinib (Tarceva). It is hoped that the results
                                           of this study will be available soon. This study recruited remarkably quickly and is a fine example of
                                           the international collaboration and co-operation that can be achieved. It is hoped that we will see
                                           results of this study in 2010.
                                           In 2008 we also saw the long awaited results of the EORTC 55971 trial in which conventional surgery
                                           followed by chemotherapy with or without interval debulking was compared with neoadjuvant
                                           chemotherapy and delayed primary surgery in Stage IIIC and Stage IV ovarian cancer. This Study
                                           eventually achieved over 700 patients. This was probably the most exciting paper presented at the
                                           International Gynaecological Cancer Society Meeting in Bangkok in 2008. The interpretation of the
                                           results has been hotly debated between investigators in Europe and in the United States, but the
                                           general consensus is that the use of neoadjuvant chemotherapy is a safe alternative in this group of
                                           patients and does not compromise the standard of care. Still, in potentially resectable cancers, primary
                                           surgery remains the treatment of choice. These study data provide a useful platform for developing
                                           new trials and studies with novel targeted agents in this group of patients with Stage IIIC and IV
3. EORTC Current Research and Strategies

                                           disease. There is a unique opportunity to collect tissue specimens before and after therapy and also
                                           to evaluate functional imaging.
                                           Inter-group has also been a tradition in the EORTC GCG group. The EORTC GCG contributed
                                           substantially to the MRC OV05/EORTC 55955 intervention trial entitled “A randomized trial in
                                           ovarian cancer of early treatment of relapsed based on CA12.5 level alone versus delayed treatment
                                           based on conventional clinical indicators”. More than 1400 ovarian cancer patients were registered
                                           in this trial, and the final results were recently presented at the Plenary Session of the ASCO 2009
                                           meeting. The results of this trial will certainly impact on clinical practice.
                                           The GCG Group has also participated internationally in the CALYPSO Study (55051) for platinum
                                           sensitive ovarian carcinoma, and these results were presented at ASCO 2009. We were also significant
                                           partners in the 55012 Study in which a comparison was made between alternating doublets and
                                           conventional chemotherapy in newly diagnosed ovarian tumours receiving first line chemotherapy;
                                           disappointingly this showed no advantage to the doublet.
It has proved to be very difficult to establish new trials even though a number of initiatives have been
identified and were being developed beyond the concept stage.

Translational Research

The Translational Research Group within the EORTC GCG has continued its efforts collecting material
from patients in previous trials and carrying out some valuable and useful work, and at the same time,
led by Dr Els Berns, a future thrust of the group has been in looking at molecular signatures and other
molecular markers which may identify adverse risk patients or predict responses to treatment. The
Group was delighted that at EGAM 2008 Dr Hellemans’ project was one of 5 chosen to be funded
by the EORTC Board, and there remains a continuing buzz of excitement within the Translational
Research Group. We have also committed annually to support translational research. The group was
also encouraged by the recognition of Dr. Evelyn Despierre´s presentation during the NOCI projects
at EGAM 2009. The Quality Assurance Group has reviewed both recent open protocols and historical
ones and are continuing to make good progress in improving the quality of data collection. Dr. Leen
Verleye, a Fellow at EORTC Headquarters, has had an important paper accepted on Surgical Quality
Control in the European Journal of Cancer.

Future Directions and Strategies

Clearly, the ability to start new Trials has been frustrating. The plans to work co-operatively with
other European partners in inter-group studies have been compromised by debates and discussions
over the regulatory processes, sponsorship, and data ownership. This in turn has led to a wider
discussion of the whole process of planning and developing inter-group studies, and it highlights the
importance of early collaboration so that some of these regulatory issues can be identified at a very
early stage.
The GCG Group remained hopeful that there will be new frontline studies in ovarian cancer opening
in 2009/10. In the meantime we are working closely with EORTC Headquarters in developing
collaborative projects. We are active members of the Gynaecological Inter Group (GCIG).

                                                                                                           3. EORTC Current Research and Strategies
                                           Head and Neck Cancer Group
                                           Structure of the Group

                                           Chair                                            J.A. Langendijk, Groningen (NL)
                                           Secretary                                        R. Knecht, Hamburg (DE)
                                           Treasurer                                        G. Andry, Brussels (BE)

                                           Subcommittee Chairs

                                           Chemotherapy                                     J. Buter, Amsterdam (NL)
                                           Radiotherapy                                     M. Sen, Leeds (UK)
                                           Surgery                                          C.R. Leemans, Amsterdam (NL)
                                           Translational Research                           A. Psyrri, Athens (GR)
                                           Quality of Life                                  S. Singer, Leipzig (DE)
                                           Imaging                                          To be appointed
                                           Young Oncologist/Scientist                       To be appointed

                                           Recent Achievements

                                           Major achievements of the Head and Neck Cancer Group (HNCG) in 2008 were in the field of larynx
                                           preservation, neoadjuvant chemotherapy in the locally advanced setting, the postoperative setting, and
                                           emerging treatment strategies in rare tumours

                                           Larynx preservation
                                           The track record of the EORTC HNCG in the field of organ preservation started with the initiation
                                           of the first larynx preservation trial in 1986, comparing induction chemotherapy (ICT) followed by
3. EORTC Current Research and Strategies

                                           radiation therapy (RT) versus total laryngectomy with partial pharyngectomy, radical neck dissection
                                           and postoperative RT (EORTC 24891). The preliminary results were published in 1996 (a landmark
                                           paper in J Natl Cancer Inst). The final results with a median follow-up of 10 years were presented
                                           at ASCO 2004. This final analysis confirmed the preliminary results and showed that the larynx
                                           preservation strategy provides similar survival curves as compared with conventional treatment
                                           and allowed 2/3 of the survivors to retain their larynx. The final analysis has been submitted for
                                           The second trial (EORTC 24954) was closed in 2004 after having accrued 450 patients. In this
                                           study, the best arm (ICT) of EORTC 24891 was compared with alternating chemo-radiotherapy in
                                           resectable hypopharynx and larynx cancers (jointly with the EORTC Radiation Oncology Group). The
                                           final results of this study were recently published in the Journal of the National Cancer Institute. The
                                           results of this study revealed no significant differences with regard to survival with functional larynx,
                                           overall survival, and progression free survival.
The 8% difference in larynx function preservation rate at 3 years in favour of alternating chemoradiation
did not translate into statistically significant survival differences (J Natl Cancer Inst. 2009 Feb
4;101(3):142-52. Epub 2009 Jan 27).
In order to evaluate the feasibility of a new combined modality approach in the larynx preservation
setting, e.g. integrating biological agents (lapatinib) with induction chemotherapy followed by
concomitant chemoradiation with lapatinib, a phase I trial was initiated in 2007 (EORTC 24051).
Unfortunately, the study had to be closed due to unexpected dose-limiting toxicities after inclusion of
7 patients. The results of this phase I study were presented during ASCO 2009 (abstract #6017).

Locally advanced setting
Another landmark paper was the publication of EORTC 24971 (N Engl J Med. 2007 Oct 25;357(17):1695-
704). In this study, the role of neoadjuvant chemotherapy (NACT) was evaluated in patients with non-
resectable locally advanced head and neck cancer and showed that with the introduction of taxanes
the role of NACT has changed. NACT is now shown to have a positive impact on survival in these
patient and, in comparison with the standard cisplatin/infusional 5-FU regimen, is shown to have a
better tolerance and a better quality of life. The results of this study will be crucial for future projects   109
within the group.
Currently, a phase II study building upon the results of the EORTC 24971 trial in the non-resectable
setting is ongoing (EORTC 24061). In this study, the feasibility and efficacy of the TPF regimen (for 4
cycles) together with the EGFR inhibitor cetuximab followed by the concomitant use of radiotherapy
and two platinum compounds, cisplatin or carboplatin (for radio sensitization), plus cetuximab is being

Postoperative setting
In 2008, the development of a new phase III protocol (EORTC 22071-24071) in the postoperative
setting has been almost finalized. This protocol was developed in close collaboration with the EORTC
Radiation Oncology Group. Based on the results of EORTC 22931, high risk patients after curative
surgery will be randomly assigned to receive postoperative chemoradiation versus postoperative

                                                                                                               3. EORTC Current Research and Strategies
chemoradiation in combination with EFGR-inhibition (panitumumab).

Rare tumours
In 2008, results of the EORTC 24982 trial were published in the European Journal of Cancer. This
phase II study was conducted to determine the anti-tumour activity of gemcitabine in adenoid cystic
carcinoma. Although gemcitabine was well tolerated by most patients, this drug showed no anti-
tumour activity in this particular group of patients.
                                           Projects / Strategies for the next years

                                           HNCG meetings structure:
                                           During the next HNCG meeting in September 2009, new subcommittees for translational research,
                                           diagnostic imaging and quality of life will be installed. To improve collaboration with other EORTC
                                           groups, representatives of the EORTC Translation Research Division, the EORTC Imaging Group
                                           and EORTC Quality of life Group will be asked to co-chair these subcommittees together with co-
                                           chairs from the HNCG. During the HNCG meetings, parallel sessions for the different subcommittee
                                           will be organized in addition to the general assembly. With this new structure, we hope to improve
                                           active involvement of more (and young) HNCG members and stimulate the initiation of additional
                                           (translational) research projects on new, ongoing and past clinical studies of the HNCG.

                                           Larynx preservation setting
                                           The HNCG decided to participate in a new 3-arm phase III study, which is now under development.
110                                        This study will be carried out in a transatlantic intergroup setting. In the past, the accrual of patients
                                           in larynx preservation studies has been difficult, and protracted accrual periods were needed to
                                           include sufficient numbers of patients, both within the EORTC network and the United States, which
                                           emphasized the need for an intergroup approach. Therefore, it was decided to participate in this
                                           Transatlantic Larynx Preservation Trial. In the new study, patients will be randomly assigned to receive
                                           concomitant chemoradiation (CRT) versus TPF-ICT followed by radiotherapy alone versus TPF-ICT
                                           followed by bio-radiation.

                                           Unresectable disease setting
                                           The locally advanced proposal for the 3-arm randomized study is still subject to negotiations with
                                           the pharmaceutical industry. In this phase III study, patients with locally advanced tumours can be
                                           included. This study has the following three arms: 1) ICT-TPF (EORTC-like) followed by bio-radiation
                                           (anti-EGFR MoAb), 2) Bio-radiation alone (anti-EGFR MoAb), and 3) Conventional chemoradiation
                                           (with cisplatin). This study will be further developed in close collaboration with the EORTC Radiation
3. EORTC Current Research and Strategies

                                           Oncology Group.

                                           Postoperative setting
                                           See the Recent Achievements section.

                                           Recurrent/metastatic setting
                                           There are three draft proposals in this setting.
Translational Research

The HNCG will focus more on translational research projects. The HNCG is in the position to have
access to extended clinical data of a number of databases of prospective randomized studies that
could be used for translational research purposes. The possibilities offered by the existence of these
high quality databases should be used more effectively and therefore the group will take actions to
actively involve investigators in the field of preclinical and translational research in the group activities
and meetings. In this respect, translational research projects could also been focussed on rare types
of tumours.
In fact, a number of TR projects have been initiated in connection to EORTC 24061. TR-studies are
also included in the EORTC 22071-24071 trial of which one proposal is NOCI-granted (collaboration
with the EORTC ROG). In the new locally advanced study, TR projects will be included as well. It is
expected that the new subcommittees will stimulate new ideas for these projects. A TR project on the
EORTC 24971 trial is now been conducted.

Quality of life (QoL)                                                                                           111
QoL assessment was included in the EORTC 24971trial. Hopefully a final draft will be submitted for
publication in 2009.
QoL assessment will also be included in all new phase III studies, as these new studies do focus on the
right balance between efficacy and toxicity. QoL projects have been included in the EORTC 22071-
24071 trial. The HNCG will also participate in a proposal of the EORTC Quality of Life Group aimed
at adjusting the EORTC QLQ-H&N35 to new treatment regimens.

Collaboration with other groups

Joint sessions with the EORTC Radiation Oncology Group during the EGAM meetings are currently
standard. A fruitful discussion with the members of the EORTC Radiation Oncology Group resulted

                                                                                                                3. EORTC Current Research and Strategies
in the aforementioned common proposals with this group. In addition, a number of meetings have
taken place between representatives of both groups, which resulted in new plans for the future
collaboration. Formal collaboration also exists with the GETTEC (Groupe d’Etude des Tumeurs de la
Tête et du Cou), and representation at each other’s meetings has been arranged.
As previously mentioned, the HNCG will work towards improving collaborations with other EORTC
The HNCG will participate in the Transatlantic Larynx Preservation Study and expressed a positive
attitude towards participation in a phase III study initiated by the GORTEC (Groupe Oncologie
Radiothérapie Tête et Cou) and GETTEC on postoperative re-irradiation.
                                           Infectious Diseases Group
                                           Structure of the Group

                                           Chair                                           P. Donnelly, Nijmegen (NL)
                                           Secretary                                       to be appointed
                                           Treasurer                                       R. de Bock, Antwerp (BE)
                                           Other members                                   O. Marchetti, Lausanne (CH)
                                                                                           C. Cordonnier, Creteil (FR)
                                                                                           P. Verweij, Nijmegen (NL)
                                           Young Scientist                                 M. Bassetti, Genova (IT)

                                           Scientific Committee

                                           The Scientific Committee comprises the Chair, the Trial Coordinators, the DRC Coordinators, the
                                           Clinical Research Physician, the Statistician, and the Data Manager. M. Paesmans has been officially
                                           appointed as the statistician to the Infectious Diseases Group (IDG).

                                           Recent Achievements Symposia and Meetings

                                           Joint EORTC IDG Educational Workshop on “Definitions and treatment outcome criteria in invasive
                                           fungal infections: an interactive workshop to reach a broader consensus” during the 19th European
                                           Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Helsinki, 16-19 May 2009.

                                           Projects / Strategies
3. EORTC Current Research and Strategies

                                           Ongoing research projects
                                           EORTC 65031 trial: Epidemiological study of fungaemia in cancer patients. The objective of the study is
                                           to assess the incidence, species distribution, risk factors and outcome of bloodstream fungal infections
                                           in cancer patients. The study was activated in 2005 and 273 patients have already been entered.
                                           European Conference on Infections in Leukemia (ECIL-2).This is a collaborative project of the EORTC
                                           IDG, the Infectious Diseases Working Party (IDWP) of the European Organization for Bone Marrow
                                           Transplantation (EBMT), the European Leukaemia Net and the International Immunocompromised
                                           Host Society (ICHS).
The second ECIL conference, held in September 2007, focused entirely on viral infections. The third
ECIL Conference will take place in Juan-les Pins, France on September 25-26, 2009 with the themes
Update of the previous ECILs antifungal guidelines (prophylaxis, empiric treatment, treatment),
Zygomycosis, and on non-invasive diagnostic procedures for invasive fungal diseases.
Microbiology Reference Laboratories (MRL). The Institute of Microbiology, Centre Hospitalier
Universitaire Vaudois, Lausanne, Switzerland is the EORTC-IDG reference centre for bacteria and
yeasts and the Department of Medical Microbiology, Radboud University Nijmegen Medical Center,
Nijmegen, The Netherlands, is the reference centre for filamentous fungi. MRL are in charge of the
quality control program regarding species identification and susceptibility testing in ongoing clinical
trials of the EORTC IDG. They are also in charge of keeping a repository of the microbial strains
collected in clinical trials. Instructions for international shipment of microbial strains will be issued in
compliance with IATA regulations.

Future Projects

The IDG has a proud history and is following in the footsteps of many illustrious pioneers. Now,               113
as then, we are facing several challenges as a group that will define our future in order to revitalise
interest in the scientific community regarding the research and treatment of infectious complications
among patients with cancer. Our thrust will be four-fold:
1)   clinical trials - exploratory, observational and intervention,
2)   diagnostic validation and utility studies,
3)   epidemiological studies and, importantly,
4)   education and training which will involve fellowships, training courses, seminars and educational
     sessions at international conferences including the Trends in Medical Mycology, The European
     Congress of Clinical Microbiology, and Infection and the International Society of Human and
     Animal Mycology (ISHAM).

Collaborations with other groups (EORTC and others)

                                                                                                               3. EORTC Current Research and Strategies
In order to perform high quality projects likely to have a major scientific impact, the collaboration with
other EORTC Groups, particularly with the EORTC Leukaemia Group and with other international
research organizations active in the field, is a top priority. An alliance has been formed between the
European Aspergillus PCR Initiative (EAPCRI), a working group of the International Society of Human
and Animal Mycology (ISHAM), and the Infectious Diseases Working Party (IDWP) of the European
Group for Blood and Marrow Transplantation (EBMT) to help propose and validate a standard for
Aspergillus PCR that can be used to screen high-risk patients. This strategy should allow more rapid
and efficient recruitment of patients. Contacts have been with the following: the EORTC Leukaemia
Group, the European Leukemia Net, the Immunocompromised Host Society (ICHS), the Infection
group of the Multinational Association for Supportive Care in Cancer (MASCC), the European
Confederation of Medical Mycology, and the US Mycosis Study Group (MSG).
                                           It is essential to conduct high quality clinical trials addressing clinically relevant issues for the
                                           prevention, diagnosis, and management of infections among cancer patients and to create a seamless
                                           interaction between the IDG, EORTC Headquarters, other organisations with a shared interest, and
                                           potential study sponsors. The Early Project Optimisation Department (EPOD) will help assist in study
                                           design, protocol development, assessment of feasibility and allocation of resources.

                                           Research projects in development

                                           Clinical trials: exploratory, observational, strategic and interventional
                                           Strategic studies: EORTC 65091 Empirical versus pre-emptive antifungal therapy in patients with
                                           haematological malignancies. A therapeutic phase III strategy study (joint effort with the Leukaemia
                                           Group, the ISHAM- EAPCRI and the EBMT-IDWP).
                                           A prospective, placebo controlled trial of quinolone prophylaxis for neutropenic patients in the
                                           setting of high-level resistance among Gram-negative bacilli (joint effort with the Leukaemia Group,
                                           the Infection group of the MASCC and the EBMT-IDWP).
                                           Observational study: A prospective study to test the feasibility to perform allogeneic reduced intensity
                                           conditioning/nonmyeloablative Stem Cell Transplantation (SCT) in 51-75 year old patients with
                                           myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) (joint effort with the Leukaemia
                                           Observational study of the development of antibacterial resistance among patients with cancer (joint
                                           effort with the Leukaemia Group, the Infection Group of the MASCC and the EBMT-IDWP).
                                           Exploratory studies: Developing pharmacokinetic profiles of antimicrobial drugs to optimize therapy
                                           of patients who develop infections whilst undergoing chemotherapy for cancer or receiving a stem
                                           cell transplant.

                                           Diagnostic validation and utility studies
                                           Prospective study to explore inflammatory markers e.g. CRP and indicators of toxicity e.g. citrulline
3. EORTC Current Research and Strategies

                                           for their potential utility as specific risk factors for infection (joint effort with the Leukaemia Group ,
                                           the Infection Group of the MASCC and the EBMT-IDWP).
                                           Establishing the optimal sampling conditions, diagnostic accuracy and clinical utility of blood cultures
                                           (joint effort with the Leukaemia Group, the Infection group of the MASCC and the EBMT-IDWP).
                                           Prospective study to explore prognostic factors for invasive aspergillosis (joint effort with the
                                           Leukaemia Group , the Infection Group of the MASCC and the EBMT-IDWP).
                                           Clinical validation of the standard for Aspergillus PCR to screen for invasive aspergillosis (joint effort
                                           with Leukaemia Group, the ISHAM-EAPCRI, EBMT-IDWP).
                                           Prospective study to explore the value of biomarkers of separately and in combination for the early
                                           detection of invasive fungal infection.
Epidemiological studies
European register of invasive aspergillosis using ECMM-internet register

Education and training
The following symposia will be organized and sponsored by the IDG at international meetings:
Trends in Medical Mycology to be held on 18-21 October, 2009 in Athens, Greece. ISHAM 2009 to be
held on June 10-12 2012 in Berlin, Germany.
Training courses and seminars using the full potential digital communications of WEB casting, Web
Events and WEBinars.

One fellowship leading to a PhD concerns the prospective epidemiology and diagnosis of invasive fungal
diseases. A second fellowship on the prospective epidemiology and clinical impact of bacteraemia due
to resistant bacteria is envisaged.

Group Web Site
Greater reliance will be placed on the IDG web site to disseminate information and archive documents
within the EORTC web site. Partner societies will be asked to provide cross-links to allow ready and
easy access.

Quality Assurance

Research projects are conducted in full conformity with EORTC standard operating procedures and
regulations, Good Clinical Practice, and the Declaration of Helsinki.

                                                                                                         3. EORTC Current Research and Strategies
                                           Leukemia Group
                                           Leukaemia Group
                                           Structure of the Group

                                           Chair                                           J.-P. Marie, Paris (FR)
                                           Secretary                                       M. Lübbert, Freiburg (DE)
                                           Treasurer                                       P. Muus, Nijmegen (NL)
                                           Young Oncologist/ Scientist                     F. Baron, Liège (BE)
                                           The EORTC Leukaemia Group is comprised of 74 qualified haematology centres located in 12 different
                                           European countries.
                                           The aim of the Leukaemia Group is to organize phase I, phase II and phase III trials for patients with
                                           myeloid or lymphoid leukaemias and myelodysplastic syndromes.
                                           Biological investigations are coordinated by subcommittees of experts on cytogenetics, molecular
                                           biology, cytology and immunology.
                                           The Leukaemia Group holds meetings on a bi-annual basis. In 2007-2008, 276 patients were included
                                           in our trials.

                                           Achievements and Strategies

                                           Acute Myeloid Leukaemia (AML) in “young” patients (< 60 years).
                                           The AML-12 (EORTC 06991) completed EORTC-GIMEMA trial included a randomisation at diagnosis
                                           for a remission induction using high-dose ARA-C compared to the “best” remission induction
                                           schedule of the previous AML-10 trial. A total of 2112 patients were registered (the randomisation was
                                           completed on 11 January 2008). A second randomisation evaluates the role of maintenance therapy
                                           with low-dose subcutaneous interleukin-2 versus no further treatment. A total of 550 patients were
                                           randomised for this second step (randomisation closed on 30 June 2008). Younger patients (< 45-55
3. EORTC Current Research and Strategies

                                           years) with an HLA identical family donor are scheduled for allogeneic transplantation. The follow-up
                                           will be long enough for final analysis in 2010-2011. A report of the first results concerning induction
                                           was selected for oral presentation at the 2008 ASH meeting : R Willemze et al, “High Dose (HD-
                                           AraC) Vs Standard Dose Cytosine Arabinoside (SDAraC) during Induction and Value of
                                           IL-2 during Maintenance in Acute Myelogenous Leukemia (AML): Impact of AraC Dose
                                           on Complete Remission Rate and Toxicity: Results on the first 1700 randomised patients
                                           of the AML-12 trial of EORTC and GIMEMA Leukemia Groups”, Blood (ASH Annual Meeting
                                           Abstracts), Nov 2008; 112: 134.
                                           An EORTC/GIMEMA network of laboratories in The Netherlands, Belgium, and Italy performed the
                                           monitoring of minimal residual disease by molecular techniques and was coordinated by Dr Joop
                                           Jansen (EORTC) and Dr Francesco LoCoco (GIMEMA).
The new ongoing phase I-II EORTC-GIMEMA protocol, EORTC 06061, is testing the addition of low
dose clofarabine to the idarubicine-ARA-C combination and is now open in a limited number of large
The group is also participating in a large intergroup study led by CALGB for young patients with
flt3-positive AML (EORTC 06071). This study aims to determine if the addition of midostaurin to
daunorubicin/cytarabine induction followed by high-dose cytarabine consolidation and continuation
therapy improves the outcome of these patients.
In elderly patients (> 60 years) with AML, the group completed the AML 17 (EORTC 06012) trial.
In 61-75 year old patients in good physical condition, this trial assessed the anti-leukaemic activity
of a sequential treatment with Mylotarg® (anti-CD33+calicheamycin) followed by “standard”
chemotherapy with mitoxantrone, Ara-C and Etoposide as a front-line therapy in previously untreated
AML. This regimen is compared to “standard” chemotherapy. The target sample size for this study was
reached and the accrual was closed as of August 2007 with a total of 473 patients randomised. Patient
follow-up and data collection is ongoing.
The AML 19 trial (EORTC 06031) was designed for the “frail” patients (> 75 or 61-75 years with co-
morbidity) who are usually not treated with intensive chemotherapy. The aim of this phase II-III trial     117
is to compare low doses of Mylotarg versus palliative care. During the phase II part, activity of two
different schedules of low dose Mylotarg have been assessed (84 patients have been entered in the
phase II). The phase III part has been open to accrual since September 2007 and patients are being
randomised between supportive care and the “best” low dose Mylotarg schedule following analysis of
the phase II results. Fifty-nine patients have already been entered out of the 179 patients needed to
be included. The first part of the phase III trial (“best schedule of Mylotarg”) was selected as an oral
presentation at the 2008 ASH meeting: Sergio Amadori et al: “Phase II–III Study of Gemtuzumab
Ozogamicin Monotherapy versus Best Supportive Care in Older Patients with Newly
Diagnosed AML Unfit for Intensive Chemotherapy: First Results of the EORTC-GIMEMA
AML-19 Trial” Blood (ASH Annual Meeting Abstracts), Nov 2008; 112: 762.
New projects are in development for elderly patients exploring new drugs such as mTOR inhibitors and
new alkylating agents (EORTC 06082). A prospective study to test the feasibility to perform allogeneic
reduced intensity conditioning/ nonmyeloablative SCT in 51-75 year old patients with myelodysplastic
syndrome (MDS) and acute myeloid leukaemia (AML), in collaboration with the Cancer in the Elderly

                                                                                                           3. EORTC Current Research and Strategies
Task Force and the Infectious Diseases Group, is now in the process of evaluation within EORTC.
The ability to receive an intensive treatment in these patients was retrospectively evaluated in our
group (Deschler B et al., “Treatment decision-making for older patients with high-risk myelodysplastic
syndrome or acute myeloid leukemia: problems and approaches”. Haematologica. 2006;91:1513).

Myelodysplastic syndromes
The Decitabine study (EORTC 06011) was a randomised study of Decitabine vs. palliative supportive
care in elderly patients ineligible for intensive chemotherapy. The trial was closed to patient entry in
May 2007 having accrued 238 patients through a joint effort between the EORTC Leukaemia group
and the German MDS Study Group.
                                           The final analysis was performed in 2008 and the final results were selected for an oral communication
                                           at the 2008 ASH meeting: P Wijermans et al: “Low Dose Decitabine Versus Best Supportive
                                           Care in Elderly Patients with Intermediate or High Risk MDS Not Eligible for Intensive
                                           Chemotherapy: Final Results of the Randomized Phase III Study (06011) of the EORTC
                                           Leukemia and German MDS Study Groups”. Blood (ASH Annual Meeting Abstracts), Nov 2008;
                                           112: 226.
                                           A new study for patients with high risk MDS is presently under discussion. This study is planning to
                                           assess different schedules of Decitabine or 5 Azacytidine (or both) in this patient population.

                                           Iron chelation therapy
                                           As toxicity of intensive anti-leukaemic therapy (chemotherapy and allogeneic SCT) can be partly
                                           attributed to iron toxicity, implementing an intensive iron chelation therapy during induction and
                                           consolidation phases of treatment for patients with AML and MDS is to be explored in order to try
                                           to reduce the treatment related toxicity. A clinical trial studying this possibility is presently under

                                           Acute lymphoblastic leukaemia (ALL)
                                           A manuscript presenting the final results of the ALL-4 trial (EORTC 06951) is in preparation and will
                                           soon be submitted for publication. This trial randomised 325 patients and compared the effects of
                                           prednisone versus dexamethasone both in the remission induction and in the consolidation phase.
                                           A second randomisation compares continuous intensive maintenance chemotherapy courses versus
                                           autologous stem cell transplantation followed by low dose maintenance courses.
                                           A new ALL first line therapy (with stratification: 18-40 years, 41-70 years) with a randomization for
                                           -/+ clofarabine i.v. during induction and intensification using a paediatric-like regimen in “young” ALL
                                           will be activated soon by HOVON and EORTC (EORTC 06083). The primary end-point will be EFS,
                                           and the secondary endpoint will be molecular residual disease.
3. EORTC Current Research and Strategies

                                           Translational Research

                                           Cytogenetics and molecular biology are now mandatory for all patients with AML or MDS. A broad
                                           molecular analysis is linked to each clinical trial, permitting identification of new prognostic molecular
                                           markers, and the development of RNA, DNA and frozen cell banks allows for better adherence
                                           to these programmes. Systematic evaluation of TCR or IgH rearrangements is planned in the next
                                           EORTC/HOVON adult ALL trial.
                                           The Leukaemia Group project presented at the 2009 EGAM meeting was fully granted by the EORTC
                                           Board. This project will permit evaluation of the prognostic importance of the deletion of TET2, a gene
                                           whose role was unknown up until now but which is found to be deleted in a significant proportion of
                                           patients with MDS and AML.
Quality Assurance

Quality assurance is mainly based on the review of patients for eligibility and evaluability performed
by the study co-ordinators along with the methodological approach of the Leukaemia Unit according
to EORTC Headquarters quality assurance procedures.
Independent review of cytology, cytogenetics, molecular biology and immunology by four subcommittees
and occasional site visits to participating centres have led to improvement in quality of the studies of
the Leukaemia Group.

Collaboration with other groups (EORTC & others)

The Leukaemia Group has a very close relationship with the Italian GIMEMA group, and many clinical
studies are joint studies of these two groups. This combination is very advantageous for both groups,
since this intergroup forms the largest group for leukaemia treatment research in the world. Our
group also has a fruitful collaboration with the German MDS Study Group and, more recently, with           119
the HOVON group for adult ALL.
The next observational study of feasibility of RIC allograft in elderly patients is being developed
together with the EORTC Cancer in the Elderly Task Force and the Infectious Disease Group. There
are also joint studies with the European Blood and Bone Marrow Transplantation Group and the
Dutch HOVON group.
The EORTC Leukaemia Group is a member of the AML Collaborative Group, which comprises all
co-operative groups (MRC, HOVON, ECOG, etc.) performing meta-analyses in AML. The EORTC
statistician was involved in the set-up of a new meeting which was held in the UK in September 2008.
Data from several EORTC trials assessing the value of SCT were provided by the EORTC statisticians
to the MRC secretariat.
Several centres from the EORTC Leukaemia Group are active participants of the European Leukaemia
Network, financed by the European Commission (Network of Excellence) since 2004, and participate
actively in the MDS, ALL and SCT working groups. Many members of the EORTC Leukaemia Group

                                                                                                           3. EORTC Current Research and Strategies
are also participating in EBMT activities. The EORTC statistician is involved in projects (guidelines,
courses) of the EBMT Statistical Subcommittee.
                                           Lung Cancer Group
                                           Structure of the Group

                                           Chair                                                      M. O’Brien, Sutton (UK)
                                           Secretary                                                  V. Surmont, Gent (BE)
                                           Treasurer                                                  B. Biesma, ‘S Hertogenbosch (NL)

                                           Steering Committee

                                           Sub-chair   Surgery                                        P. Van Schil, Antwerp (BE)
                                           Sub-chair   Pathology                                      K. Kerr, Aberdeen (UK)
                                           Sub-chair   Oncology                                       D. Fennell, Belfast (UK)
                                           Sub-chair   Radiotherapy                                   C. Faivre-Finn, Manchester (UK)
                                           Sub-chair   Quality Assurance                              R. Gaafar, Cairo (EG)
                                           Sub-chair   Radiology                                      C. Fink, Mannheim (DE)
                                           Young Oncologists                                          R. Dziadziuszko, Gdansk (PL)
                                                                                                      L. Greillier, Marseille (FR)
                                           The Group officers include the Secretary, Treasurer and the Sub-chairs of the different specialties such
                                           as chemotherapy, radiotherapy, surgery and pathology.

                                           Recent Achievements

                                           In 2008 two trials were closed and have been analysed, two trials were opened for patient entry, and
                                           one trial was in protocol development. A total of 106 patients were entered in EORTC Lung Cancer
                                           Group trials in 2008.
3. EORTC Current Research and Strategies

                                           Non-Small Cell Lung Cancer (NSCLC)

                                           EORTC 08021 trial: A randomised phase II study of follow-up with or without adjuvant gefitinib
                                           (Iressa) following chemotherapy in patients with advanced NSCLC. This trial closed in 2008 due to
                                           slow accrual along with other negative studies using iressa, e.g. ISEL (Iressa Survival Evaluation in Lung
                                           cancer). SATURN (Sequential Tarceva in Unresectable NSCLC), a similar study using tarceva, has been
                                           positive for the primary endpoint of PFS. Iressa has recently received its license only in patients with
                                           mutations of EGFR.
                                           EORTC 08051 trial: A randomised phase II study of pemetrexed and cisplatin as either induction or
                                           adjuvant chemotherapy in stage IB-II NSCLC. This study closed in 2008 because of poor recruitment
                                           and reported no added benefit of neoadjuvant chemotherapy compared to adjuvant treatment.
EORTC 22055 - 08053 trial: Lung Adjuvant Radiotherapy Trial (ART) evaluating the role of postoperative
conformal radiotherapy after complete resection of NSCLC with N2 mediastinal involvement. This
trial was closed prior to recruiting its first patient. Despite the relevance of the question addressed
by this protocol, its feasibility was not guaranteed.
EORTC 75082 - 08086 trial: Randomized phase II trial of abraxane versus navelbine for patients aged
70 or older with NSCLC. This study is under development in collaboration with the EORTC Cancer
in the Elderly Task Force.

Small Cell Lung Cancer (SCLC)

EORTC 22003 - 08004 trial: International Prophylactic Cranial Irradiation (PCI) trial. This multicentre,
randomised trial was a joint study with the RTOG and the PCI 99-EULINT1 collaborative group.
It built on our previous positive trial of PCI for small cell lung cancer and examined the effect of
different doses of radiation in PCI to limited stage SCLC in complete responders. The study is closed,
and the data presented. In summary the higher dose of radiotherapy is no better than the current
standard dose.                                                                                                121
EORTC 22074 - 08072 trial: CONVERT: a phase III study together with the EORTC Radiation Oncology
Group and Medical Research Council has started. The study is considered to be of great importance
for patients with limited stage SCLC and is designed to answer the question of dosing and timing of
radiation to the chest. Patients will be randomised to receive twice daily radiation with concurrent
chemotherapy versus four courses of chemotherapy followed by high dose radiation of 66 Gy.
EORTC 08061 trial: Phase II study of sunitinib in patients with SCLC who are either chemonaive (ED)
or have a sensitive relapse. In this phase II study 48 patients will be entered in the two different groups
and will be treated with the oral agent sunitinib for four weeks. The main end point of this study is
disease control at four weeks determined by CT and PET scan. Non-responding patients will be given
standard chemotherapy after evaluation. The study opened in 2008 and has specific FDG-PET scanning
and translational research questions.
EORTC 08062 trial: Randomised phase II study of amrubicin as single agent or in combination with
cisplatin versus etoposide/cisplatin as first-line treatment in patients with extensive stage SCLC. The

                                                                                                              3. EORTC Current Research and Strategies
recently reported promising results from Japanese studies in SCLC are now tested in Caucasian
patients. Amrubicin single agent or amrubicin with cisplatin will be compared with the standard
treatment with cisplatin/etoposide. The study has completed recruitment and will be analysed in 2010.
The primary end-point is response rate, and secondary end-points focus on progression free survival,
toxicity and overall survival.


EORTC 08031 trial: A phase II feasibility trial of induction chemotherapy followed by extra pleural
pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesothelioma.
The study completed recruitment and has been analysed.
                                           The study investigated the feasibility of combining induction chemotherapy, extra pleural
                                           pneumonectomy and hemi-thoracic irradiation in patients with early stage mesothelioma. The
                                           endpoint is the number of patients alive and without significant toxicity or disease at 90 days after the
                                           last treatment, and the data suggest that this is only possible in <50% of patients.
                                           EORTC 08052 trial: A phase II study of bortezomib (Velcade) with cisplatin as first-line treatment of
                                           malignant mesothelioma. This trial is assessing the effect of bortezomib with cisplatin in patients with
                                           inoperable malignant mesothelioma. The primary endpoint is progression free survival at 18 weeks,
                                           and secondary endpoints are overall survival and toxicity. This study has completed the first cohort
                                           and confirmed an acceptable progression free survival rate. A translational research component of
                                           this study is linked to the EORTC 08031 trial. The study should finish in late 2009.

                                           Projects / Strategies for the next year

                                           The objective of the Group is to promote large randomised studies in stage IIIB-IV non-small cell lung
                                           cancer. Our aim is to explore issues in chemotherapy and targeted therapies which are unlikely to be
122                                        investigated by the pharmaceutical industry, and to include translational and economic endpoints.
                                           We have also focused on studies that enable us to work together with the EORTC Radiation Oncology
                                           Group. Such studies are difficult to fund as they are rarely of interest to the pharmaceutical industry
                                           or radiotherapy manufacturers. Two such studies in small and non-small cell lung cancer are about to
                                           open, and discussions continue about a third study in potentially operable non-small cell lung cancer.

                                           Quality Assurance

                                           Quality assurance remains an important issue with emphasis being placed on the selection of new
                                           members and timelines of submitting patient research data. The increasing regulation associated with
                                           opening trials has meant limiting individual studies to a small number of countries with corresponding
                                           negative effects on recruitment.
3. EORTC Current Research and Strategies

                                           Translational Research

                                           Translational research is part of many of our studies, and data collection and tissue storage for future
                                           use are considered very important. However, ethical issues need to be considered. Our pathology
                                           Sub-chair and Young Oncologist have been active in developing protocols for tissue transport and
                                           research and in stimulating our other members to send tumour specimens for pathology review
                                           and confirmation, testing of the folate pathway and preparing Affymetric-based gene analyses using
                                           tumour-specific arrays for patients with mesothelioma. This could enable future development of
                                           personalized therapies based on tumour gene profiles. The EORTC Lung Cancer Group will continue
                                           to invest in these studies.
Lymphoma Group
Structure of the Group

Chair                                             R.W.M. van der Maazen, Nijmegen (NL)
Secretary                                         P. Meijnders, Antwerpen (BE)
Treasurer                                         Y. Lievens, Leuven (BE)

Executive Committee

Acts as a daily board, handles business matters, and prepares the semi-annual business and general
group meetings. It consists of the Chair, the Secretary, the Treasurer and the following members: L.
Moser , J.C. Kluin-Nelemans , J.M.M. Raemaekers, Liliana Baila.

Scientific Steering Committee                                                                                  123

The Committee was established in 2007 and is responsible for the scientific strategy of the Group.
It organises scientific meetings and/or brainstorming sessions for the whole group and evaluates
ongoing studies together with the study coordinators and considers the need for amendments. The
meeting is open to all members.
Co-ordinator                                      J.M.M. Raemaekers, Nijmegen (NL)
Young Oncologist                                  E. Moser, Brest (FR)

Pathology Committee

A panel of expert pathologists, chaired by J. Bosq,Villejuif, meets bi-annually to review central histologic
data and discuss borderline cases.

                                                                                                               3. EORTC Current Research and Strategies
Co-ordinator                                      D. de Jong, Amsterdam (NL)
Members                                           J. Audouin, Paris (FR)
                                                  J. Chasles, Caen (FR)
independent external experts                      J. Diebold, Paris (FR)
                                                  K. MacLennan, London (UK).

Radiotherapy Committee

Focuses on new strategies in radiotherapy and develops quality control and assurance programmes
for ongoing and new studies.
                                           Co-ordinator                         T. Girinsky, Villejuif (FR)
                                           Members                              B.M.P. Aleman, Amsterdam (NL)
                                                                                M. Beijert, Groningen (NL)
                                                                                Y. Lievens, Leuven (BE)
                                                                                R.van der Maazen, Groningen (NL)
                                                                                P. Meijnders, Antwerpen (BE)
                                                                                E. Noordijk, Oegstgeest (NL)
                                                                                P. Poortmans, Tilburg (NL)
                                                                                P. Richaud, Bordeaux (FR)
                                                                                L. Specht, Copenhagen (DK)

                                           Recent Achievements

                                           On-going trials
                                           Study 20051: Intergroup trial (J.M.M. Raemaekers): The H10 EORTC/GELA/ILL randomised
                                           Intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined
                                           modality treatment in patients with supradiaphragmatic stage I/II Hodgkin’s lymphoma.
                                           Study 20012: Intergroup trial (P. Carde): BEACOPP (4 cycles escalated + 4 cycles baseline) versus
                                           ABVD (8 cycles) in stage III & IV Hodgkin’s Lymphoma.

                                           Recently closed trial

                                           Study 20971 (M. Beijert): Phase III randomised study of low-dose total body irradiation and involved
                                           field radiotherapy in patients with localized, stage I and II, low-grade non-Hodgkin’s lymphoma. Two
                                           hundred patients have been included, but due to too slow accrual the trial has been closed.
3. EORTC Current Research and Strategies

                                           Presentations & Publications 2008

                                           - Girinsky T, Specht L, Ghalibafian M et al: The conundrum of Hodgkin lymphoma nodes: to be or not
                                           to be included in the involved node radiation fields. The EORTC-GELA lymphoma group guidelines.
                                           Radiother Oncol. 2008 Aug; 88(2): 202-10.
                                           - Van Oers M, Van Glabbeke M, Baila L et al. Rituximab maintenance treatment of relapsed /resistant
                                           follicular non-Hodgkin’s lymphoma: long-term outcome of the EORTC 20981 phase III randomized
                                           Intergroup study. Communication at the 50th ASH Annual meeting, San Francisco, December 6-9,
- Aurer I, Eghbali H, Raemaekers J et al. Gem-(R)CHOP versus (R)CHOP: a Randomized Phase II
Study of Gemcitabine Combined with (R)CHOP in Untreated Aggressive Non-Hodgkin’s Lymphoma -
EORTC Lymphoma Group Protocol 20021. Poster presentation at the 50th ASH Annual meeting, San
Francisco, December 6-9, 2008
-Van Oers M, Van Glabbeke M, Baila L et al. Rituximab maintenance treatment of relapsed /resistant
follicular non-Hodgkin’s lymphoma: long-term outcome of the EORTC 20981 phase III randomized
Intergroup study. Blood (ASH Annual Meeting Abstracts)112: 836, 2008.
- Aurer I, Eghbali H, Raemaekers J et al. Gem-(R)CHOP versus (R)CHOP: a Randomized Phase II
Study of Gemcitabine Combined with (R)CHOP in Untreated Aggressive Non-Hodgkin’s Lymphoma -
EORTC Lymphoma Group Protocol 20021. Blood (ASH Annual Meeting Abstracts) 112: 3609, 2008.

Projects / Strategies for the next years

Hodgkin Lymphoma has become the main priority of the Group.
Early stage Hodgkin’s Lymphoma

In the ongoing EORTC 20051 (H10) trial the treatment is stratified according to pre-treatment risk
profile and guided according to early FDG-PET scan evaluation. This response-adapted strategy is
expected to result in continued high efficacy but reduced toxicity.
The ILL has joined the study and together with the GELA accrual of the study is excellent (ahead of
predicted accrual: almost 1000 patients included / 1600 needed).
Central PET review has been realised in the H10 trial. Due to great efforts of a dedicated team of
nuclear physicians and HQ, central review of PET-scans after 2 courses of chemotherapy could be
realised in 60% of patients in the 1st Q of 2009. The aim is that 90 % of the PET-scans will be centrally
Our experiences with central PET review are being combined with those of the GELA (Meignan et

                                                                                                            3. EORTC Current Research and Strategies
al. JCO 2009).
In H7 and H8 trials a group of patients with very favourable characteristics was selected and treated
with mantle field radiotherapy only. This subgroup of patients is being evaluated and a publication is
in preparation.

Advanced stage Hodgkin’s Lymphoma

The Group is the leading group in a large Intergroup and multinational phase III trial in unfavourable
advanced Hodgkin’s Lymphoma (20012) with the aim to improve the prognosis in unfavourable cases.
It is expected that in 2009 accrual can be closed as planned.
                                           Together with the GELA and IIL a new study is being prepared. The same concept will be applied as
                                           in the H10 study: Individualised treatment based on early PET response aiming at maximal cure rates
                                           and minimal toxicity.

                                           Relapsed or refractory Hodgkin’s Lymphoma

                                           The Group is a member of the cooperative study consortium. Recently the HDR2 study has been
                                           closed and a final joint publication is being awaited. Preparations are ongoing for a new HDR3
                                           study. The HDR3 study will focus on the induction chemotherapy schedule and the possible role of
                                           maintenance therapy.
                                           In collaboration with Early Project Optimisation Department (EPOD) new treatment strategies
                                           in Hodgkin lymphoma are being explored. HDAC and mTOR inhibitors seem the most interesting
                                           compounds at the moment.

                                           Quality of life theme group
                                           The Group has included more than 6000 patients in HL trials over the last 45 years. The median
                                           follow-up time is more than 20 years and the Group will continue to evaluate the treatment burden
                                           as cause of secondary cancers and non neoplastic complications (Favier et al. Cancer 2009). A
                                           clinical update of all HL patients has been started and all living patients will receive a Life Situation
                                           Questionnaire. Questions in six domains (general, parenthood, education/work, health, social life,
                                           support) will provide extensive information on the quality of life of these long-term survivors. Part
                                           of this study is financed by the Lance Amstrong Foundation. The questionaires are being sent out to
                                           the patients, as of May 2009.
                                           Prospective and sequential QoL-monitoring is incorporated in early stage HL trials (H8 and H9) and
                                           is performed by H. Flechtner, Cologne.The study co-ordinators and statistician of H8 and H9 trials are
                                           closely involved: H. Eghbali, J. Raemaekers, M. Henry-Amar and C. Fermé (from the collaborating group
                                           GELA). A publication on quality of life evaluation in H8 is submitted to Lancet Oncology.
3. EORTC Current Research and Strategies

                                           Fertility studies

                                           Following the successful analysis on the quality of spermatogenesis of early stage Hodgkin’s Lymphoma
                                           patients after chemotherapy by van der Kaaij et al (JCO 2007), the study is extended to an analysis of
                                           the quality of spermatogenesis prior to therapy in relation to stage and the presence of B symptoms.
                                           The manuscript has been accepted by Haematologica.
Quality Assurance

The central PET-review in the H10 study has been established and the aim is that 90% of the PET-scans
will be centrally prospectively reviewed. Patients are being treated according to the judgement of the
central review committee.
The radiotherapy subcommittee continues to perform early retrospective quality control, to develop
new radiotherapy guidelines and takes responsibility for the implementation of these guidelines. The
pathology committee has extensive experience in reviewing material from patients included in trials.

Translational Research

The Group participates in the current international work based on molecular biological markers
collected from closed trials (International Lunenburg Lymphoma Biomarker Consortium). The aim
is to define new prognostic biomarkers based on a retrospective analysis combined with tissue
microarray analysis (De Jong et al. J Clin Pathol 2009).                                                  127
In addition, a large study on the prognostic role of vascular and stromal factors in Hodgkin’s Lymphoma
tissue specimens is ongoing (De Jong et al. Haematologica 2009).
Expression of Thymus and Activation Regulated Cytokine (TARC) is elevated in HL cell lines and
tissues. TARC can be demonstrated in the serum of patients with untreated HL. It could be used as
an early predictor of refractory or recurrent disease. (Contacts with Prof. Van den Berg, University
Hospital Groningen, NL).
Collaboration will be sought with the Translational Research Unit of the EORTC for developing TR
projects. A translational research question should be incorporated in all new Hodgkin trials.

Collaboration with other groups

EORTC Radiation Oncology Group                                     P. Poortmans

                                                                                                          3. EORTC Current Research and Strategies
International Cochrane Review Group                                L. Specht
German Hodgkin Study Group                                         J.M.M. Raemaekers
International Mantle Cell Network                                  J.C. Kluin-Nelemans
Groupe d’Etudes des Lymphomes de l’Adulte (GELA)                   P. Carde & J.M.M. Raemaekers
Intergruppo Italiano Linfomi                                       J.M.M. Raemaekers & T. Girinsky
                                           Melanoma Group
                                           Structure of the Group

                                           Chair                                              P. Patel, Nottingham (UK)
                                           Secretary                                          D. Schadendorf, Essen (DE)
                                           Treasurer                                          G. Ghanem, Brussels (BE)
                                           The Melanoma group has eight committees concerned with the management of cutaneous and ocular
                                           melanoma, the development of new treatment strategies, and basic science conducting epidemiologic,
                                           genetic, and pathologic studies in melanoma. Among them, the Translational Research Committee
                                           acts as an umbrella committee to foster lateral interactions between the research interests of the
                                           group in pathology, genetics, and epidemiology. The overall goal is cross-fertilisation of the various
                                           committees, integration of young scientists into the group, and prioritisation of topics to be included
                                           as translational studies in clinical trials. Key to this is the extensive phase III trial programme regarding
                                           treatments in virtually all stages of melanoma. This is supplemented with pathology studies focusing
128                                        on molecular defects associated with melanoma progression and identification of new potential
                                           therapeutic targets, genetic studies focusing on constitutional factors associated with melanoma
                                           prognosis, and large epidemiological investigations focusing on the relation of various aspects of UV
                                           irradiation and melanoma risk. The committee structure is adapted to the activities of the group as
                                           Chair Adjuvant Therapy Committee                   A.M.M. Eggermont, Rotterdam (NL)
                                           Chair Epidemiology Committee                       J. G. Coebergh, Rotterdam (NL)
                                           Chair Genetics Committee                           J. Newton Bishop, Leeds (UK)
                                           Chair Ocular Melanoma Committee                    S. Leyvraz, Lausanne (CH)
                                           Chair Pathology Committee                          M. Cook, Guildford (UK)
                                           Chair Stage IV Melanoma Committee                  U. Keilholz, Berlin (DE)
                                           Chair Surgery Committee                            A. Testori, Milan (IT)
                                           Chair Translational Research Committee             D. Schadendorf, Mannheim (DE)
                                           Young Oncologists / Scientists                     S. Ugurel, Mannheim (DE)
3. EORTC Current Research and Strategies

                                                                                              L. van Kempen, Nijmegen (NL)

                                           Recent Achievements

                                           Completed trials:

                                           STAGE IV
                                           EORTC 18951-Randomised phase III study of DTIC, CDDP, INF alpha with or without IL-2 in
                                           disseminated melanoma. Study coordinators: U. Keilholz and A. M. M. Eggermont.
The study results were published in 2005 (J Clin Oncol 2005; 23: 6747-55). This trial was amended to
evaluate in a randomised phase II fashion, whether two cycles of initial DTIC can be used to positively
select patients for more intensive chemo-immunotherapy. The results which were not supportive
of that strategy were published in 2006 (Punt CJ et al, EJC 2006; 42: 2991-5). In addition the pre-
treatment level of leukocytes/neutrophils was found to be a novel independent prognostic factor
for survival (Schmidt H et al, JCO 2007; 25: 1562-9)..Recently, this study was used in a retrospective
analysis: Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S,
Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised
trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 May 4. [Epub ahead of print]
PubMed PMID: 19419855

EORTC 18032- Extended schedule, escalated dose Temozolomide versus Dacarbazine in Stage IV
metastatic melanoma: a randomised phase III study. Study coordinator: P. Patel
This trial, the largest ever to date in stage IV melanoma, evaluated the use of an extended schedule,
escalated dose temozolomide in stage IV melanoma. The trial recruited 859 patients over 4 years, at
its peak recruiting over 40 patients/month. Patients were randomised to receive Arm A:Temozolomide          129
150mg/m2/day orally days 1-7 repeated every 14 days (‘week on - week off ’) or Arm B: Dacarbazine
1000mg/m2 IV every 21 days. The 2 arms were well matched for age, sex, ECOG PS and LDH. There
were <2% patients who had major protocol violations. There was no significant difference in overall
survival. Median survival was 0.76 (TMZ) and 0.78 y (DTIC); hazard ratio 0.99. Median PFS was equal
in both arms: 0.19 vs. 0.18 mo. Overall RR was 14.5 vs. 9.8 % ( TMZ vs. DTIC). The main toxicities
were haematological and were more pronounced in the TMZ arm (41.3% vs. 23.6% grade 3 / 4 ). This
extended schedule Temozolomide regimen gives no survival advantage over Dacarbazine in stage
IV melanoma. The results were presented at ESMO 2008 in Stockholm, and the manuscript is in

EORTC 16032-18031- Randomised, open phase II study of immunization with the recombinant
MAGE-3 protein combined with adjuvant AS02B or AS15 in patients with unresectable and
progressive metastatic cutaneous melanoma. Study coordinator: W. Kruit

                                                                                                            3. EORTC Current Research and Strategies
This trial evaluated the activity and toxicity of the two adjuvants, AS02B and AS15, in combination
with MAGE-3 protein in the treatment of metastatic cutaneous melanoma. This trial screened 165
patients and randomised 75 patients. In the AS15 group, 3 CR were seen with a duration of 11, 23+
and 32+ months, respectively, and 1 partial response (5 months). In the AS02B group, 1 PR (7 months)
was found, while 5 patients in each group had stable disease (i.e., with a duration of > 16 weeks). Anti-
MAGE-3 antibody titres were higher in the AS15 arm than in the AS02B arm. CD4+ T-cell responses
were observed in 72% (AS15) versus 36% (AS02B). The results were presented at ACSO 2008 and the
final manuscript is in preparation. An update of the follow-up is currently being performed.
                                           STAGE III
                                           EORTC 18991 - Randomised phase III: Adjuvant PEG Intron (5 years) versus observation after
                                           regional lymph node dissection in AJCC Stage III (TxN1M0) melanoma patients: a multicenter
                                           randomised phase III trial. Study coordinator: A. M. M. Eggermont
                                           This trial investigated the effect of long-term therapy (5 years) with the long-acting pegylated interferon
                                           alpha 2b (PEG-Intron) versus observation on relapse-free survival (RFS), distant metastasis-free
                                           survival (DMFS) and overall survival, in high risk melanoma patients after full lymph node dissection
                                           of positive regional lymph nodes. Total accrual of 1256 patients was reached in June 2004. The cut-off
                                           date was 31 March 2006. The database, located at EORTC Headquarters, was frozen in December
                                           2006. Final analysis was performed in 2007. The median length of treatment with PEG-Intron was 12
                                           months. At 3.8 years median follow-up, 328 recurrence events had occurred in the interferon group
                                           compared with 368 in the observation group (hazard ratio 0.82, 95% CI 0.71–0.96; p=0.01); the 4-year
                                           rate of RFS was 45.6% (SE 2.2%) in the interferon group and 38.9% (2.2%) in the observation group.
                                           There was no difference in overall survival between the groups. Grade 3 adverse events occurred in
                                           246 (40%) patients in the interferon group and 60 (10%) in the observation group; grade 4 adverse
                                           events occurred in 32 (5%) patients in the interferon group and 14 (2%) in the observation group.
130                                        In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients,
                                           16%), hepatotoxicity (66, 11%), and depression (39, 6%). Treatment with PEG-Intron was discontinued
                                           because of toxicity in 191 (31%) patients.
                                           The EORTC QoL Department performed the analysis of the QoL data collected in this trial. Significant
                                           and clinically meaningful differences occurred with PEG-IFNα-2b treatment arm compared to the
                                           observation group and showed decreased global health related quality of life (HRQoL) at month
                                           three (-11.6 points; 99% CI [-8.2 ; -15.0]) and year two (-10.5 points, 99% CI [-6.6 ; -14.4]). Many of
                                           the other scales showed statistically significant differences between scores when comparing the two
                                           arms. From a clinical point of view important differences were found for five scales: two functioning
                                           scales (social and role functioning) and three symptoms (appetite loss, fatigue and dyspnea), with the
                                           PEG-IFNα-2b arm being most impaired.
                                           Conclusion: Adjuvant PEG-Intron for stage III melanoma has a significant, sustained effect on
                                           recurrence-free survival. There was an expected negative effect on global HRQoL and selected
                                           symptoms when patients undergo PEG-IFNα-2b treatment. These findings therefore must be weighed
3. EORTC Current Research and Strategies

                                           against any clinical benefit of therapy. The results were presented at ASCO 2007 and were published
                                           in the Lancet (Eggermont et al. Lancet 2008). Patients will be followed for survival for a total of 10
                                           years. QoL results have been published in the JCO (Bottomley et al. JCO 2009).

                                           STAGE II
                                           EORTC 18961-Post-operative adjuvant ganglioside GM2-KLH/QS21 vaccination treatment after
                                           resection of high risk primary melanoma (> 1.5mm) (TNM: T3-4N0M0: stage II). A 2-arm multi-
                                           centre randomised phase III trial. Study coordinator: A. M. M. Eggermont
This trial investigated whether following excision of a high risk primary melanoma (>1.5mm) treatment
with the ganglioside vaccine GM2-KLH/QS21 for a period of 3 years would improve DFS and OS.
The study reached the required number of patients and was closed to patient entry in December
2005. An interim analysis took place in 2007. For the primary endpoint DFS, the criteria for stopping
for futility were met: the hypothesis of a treatment difference could be rejected in favour of the null
hypothesis of no difference (stratified HR = 1, with p = 0.99). For DMFS and OS, the results were
pointing in the direction of a difference in favour of observation (with p = 0.10 and 0.02, respectively).
The IDMC recommended that trial EORTC 18961 be stopped as it was highly unlikely that a benefit
of the vaccine would be observed. The recommendation was immediately endorsed by the Melanoma
Group and the treatment with the vaccine was stopped in the patients still receiving treatment. The
number of events for the final analysis has now been reached and the final report is in preparation.

Ongoing Studies

Uveal Melanomas
EORTC 18021- Intravenous versus intra-arterial fotemustine chemotherapy in patients with liver               131
metastases from uveal melanoma: a randomised phase III study. Study coordinator: S. Leyvraz
This trial was activated at the end of 2004 and targets 262 patients with liver metastasis from uveal
melanomas. This protocol runs within a network of EORTC institutions experienced with uveal
melanoma and having facilities for intra-arterial hepatic perfusion.

EORTC 18071: Adjuvant Immunotherapy with anti-CTLA-4 Monoclonal Antibody (ipilimumab)
versus Placebo after complete Resection of high-risk Stage III Melanoma: A randomised, double-
blind Phase III Trial. Study coordinator: A. Eggermont
The primary objective of this study is to prospectively assess whether post-operative adjuvant therapy
with ipilimumab improves RFS, OS and DMFS as compared to placebo in high-risk patients with
complete resection of Stage IIIA (<1mm metastasis), IIIB and IIIC (no in-transit metastasis) melanoma.
A total of 950 patients will be randomised. The study is sponsored by Bristol Meyers Squibb for

                                                                                                             3. EORTC Current Research and Strategies
registration of ipilimumab in this indication. The protocol has been activated, patient recruitment has
started, and about 100 patients have entered the study.

Translational Research

In 2005-2006, the Melanoma Group conducted the first genomics study on a large cohort of frozen
primary melanomas. The data coming from genomic-related studies have shed light on several key
molecular interactions that are crucial for metastatic potential such as:
The key role played by the genes involved in chromatid separation during melanoma progression (J
Natl Cancer Inst 2006; 98: 472-82.), especially hPTTG1/Securin (Mod Pathol 2006; 19: 1170-80).
                                           The association between a high expression of DNA repair genes and poor prognosis. More recently,
                                           the integration of RNA genomics with DNA data has made it possible to identify that genes whose
                                           expression are associated with BRAF mutations are not simply restricted to the MAP/ERK signalling
                                           but also converge to enhance immune responsiveness, cell motility and melanosomes processing
                                           involved in the adaptative UV response (Mol Oncology 2008; 1: 425-430).
                                           There is an evidence level 2 that sentinel node (SN) is the best staging procedure in cutaneous
                                           melanoma. Patients with negative SN constitute a homogeneous group of patients with good
                                           prognosis (85% 5-year survival rate). Therefore, only patients staged by SN procedure will be included
                                           in adjuvant trials. This SN micro-staging should systemayically follow the protocol established by
                                           the EORTC Melanoma Group, as differences in pathology protocols can lead to variations in the
                                           SN reliability. In the meantime, there is a need to better understand the individual susceptibility to
                                           melanoma relapse. For instance, 50% of the patients with a micro-metastatic SN will die from their
                                           disease. There is a strong need to better understand at the N1 stage what factors are behind the risk
                                           for relapse. A constitutional genetics study has been launched to address this issue.
                                           It has been demonstrated by the Erasmus group that SNs with micro-metastases below 0.1mm in
                                           diameter are associated with virtually the same prognosis as negative SN (Ann Oncol. 2006;17:1578-
132                                        85 and Br J Surg. 2007; 94: 1293-9). Whether SNs with small micro-metastases should lead to CLND
                                           or not will be addressed by a controlled study currently in preparation. The Melanoma Group is
                                           conducting a registration study examining the outcome of conservative management in low risk
                                           minimal microscopic SN positive patients (MINUTUB study).
                                           A comprehensive study on the immune response in primary melanoma and SNs, including in situ
                                           evaluation of dendritic cells, has been conducted. Patients with a high density of DC-LAMP+ mature
                                           dendritic cells (>200/mm2) in the SN have the lowest risk of death. This accumulation of mature DCs
                                           confers a prolonged (>10 years) protector effect for both metastasis and death (ASCO 2007 and
                                           Clin Cancer Res 2007; 13: 3825-30). A retrospective analysis of 1,600 primary melanomas with long-
                                           term follow-up has been done in collaboration with the Dana Farber Cancer Institute to evaluate
                                           whether Tumour-infiltrating lymphocytes (TILs) infiltrate affects melanoma progression and to better
                                           characterise immunologically melanomas with brisk TILs infiltrate. Based on the Cox model, brisk
                                           TILs were an independent prognostic factor for DFS (p<0.001) controlling for thickness, mitotic
                                           count, ulceration, gender, age and site. Remarkably, no death was observed in the 5.5% of “super-
3. EORTC Current Research and Strategies

                                           responders” melanomas with dense, brisk TILs infiltrate at ten years. (ASCO 2007 and manuscript in
                                           Gogas and colleagues have recently reported that patients treated with adjuvant interferon who
                                           developed auto-antibodies against thyroglobulin, antinuclear factors, or cardiolipin had a significantly
                                           better outcome than patients that did not develop these signs of autoimmunity (N Engl J Med. 2006;
                                           354: 709-18). These results however have not been confirmed by our studies. The results of the auto-
                                           antibody study of the adjuvant IFN intermediate dose trial (EORTC 18952 and Nordic IFN trial) have
                                           been published in the JNCI (Bouwhuis et al, 2009). The group has demonstrated a potentially very
                                           important interaction between response to adjuvant interferon and ulceration in a retrospective
                                           analysis of its EORTC 18952 and 18991 studies. The results presented in an oral presentation at
                                           ASCO 2009 show a significant benefit of adjuvant interferon vs. observation only in patients with
                                           ulcerated primaries.
The effect is more marked in patients with stage II disease and microscopic stage III disease. By
contrast, no benefit is seen in patients with non ulcerative disease. The study forms the basis for the
next adjuvant study targeting patients with ulcerated primaries.

Collaboration with other groups

In the EORTC

EORTC PathoBiology Group and the EORTC Tissue Bank
Pathology quality assurance for the Melanoma Group trials and tissue collection for translational
research make use of the virtual microscope platform implemented at EORTC Headquarters. The
establishment of the Melanoma Group biobank related to the Melanoma Group trials should continue
to permit rapid and detailed analyses of specific questions.
Outside the EORTC

Dana Farber Cancer Institute
A retrospective analysis of 1,600 primary melanomas with long-term follow-up has been performed
to evaluate whether TILs infiltrate affect melanoma progression and to better characterise
immunologically melanomas with brisk TILs infiltrate.

CHEMORES Consortium
Members of the EORTC Melanoma group are also active participants in the FP6 funded CHEMORES
consortium. CHEMORES is an integrated project involving clinicians and scientists at 17 universities,
organizations for cancer research, and research-oriented biotechnology companies in eight European

                                                                                                                 3. EORTC Current Research and Strategies
countries.The purpose of the project is to improve cancer treatment by obtaining increased knowledge
on mechanisms of chemotherapy resistance.
Within the frame of CHEMORES the EORTC Melanoma Group is also collaborating with the AIM
HIGH Study Group and the Nordic Adjuvant Group to constitute in Europe two unique centralized
collections of tissues blocks. This strategy is part of an international collaborative effort initiated by Pr.
Julia Bishop in Leeds to investigate predictive factors of interferon treatment in melanomas.
                                           Pathobiology Group
                                           Structure of the Group

                                           Chair                                           M.G. Daidone, Milan (IT)
                                           Secretary                                       J. Dittmer, Halle (DE)
                                           Treasurer                                       A. Geurts, Nijmegen (NL)
                                           Chair-elect                                     J. Martens, Rotterdam (NL)
                                           Translational Research Chair                    M. Schmitt, Munich (DE)
                                           Clinical Trial Representative                   N. Harbeck, Koeln (DE)
                                           Biorepositories Chair                           P. Martin, Marseille (FR)
                                           Quality Assurance Biomarkers Chair              F. Sweep, Nijmegen (NL)
                                           Quality Assurance PathoBiology Chair            R. Salgado, Antwerp (BE)
                                           NCI-EORTC Affairs                               N. Brünner, Copenhagen (DK)
                                           Clinical Affairs                                N. Harbeck, Cologne (DE)
134                                                                                        C. Thomssen, Halle (DE)
                                           Basic Affairs                                   J. Foekens, Rotterdam (NL)

                                           Young Oncologist/Scientist Tumour Biology       O. Gluz, Düsseldorf (DE)
                                           Young Oncologist/Scientist Pathology            L. Libbrecht, Gent (BE)
                                           The Executive Committee of the Pathobiology Group (PBG) is comprised of the Chair, Chair-elect,
                                           Secretary, and Treasurer.
                                           The Steering Committee of the PBG is comprised of the members of the Executive Committee,
                                           Translational Research Chair, Biorepositories Chair, Quality Assurance Biomarkers Chair, Quality
                                           Assurance Pathology Chair, NCI-EORTC Affairs Officer, Clinical Affairs Officers, Basic Affairs Officer,
                                           Young Oncologist/Scientist Tumour Biology, and Young Oncologist/Scientist Pathology.

                                           Recent achievements
3. EORTC Current Research and Strategies

                                           The PBG mission is to carry out studies aimed at increasing the knowledge of the molecular
                                           mechanisms underlying tumour development and progression in order to provide clinically relevant
                                           information for patient management. In achieving these goals, the PBG has always been active in various
                                           translational research studies concerning a number of cancer types (the most prominent being breast,
                                           colorectal, and ovarian cancers) to provide level of evidence-type-one for clinical implementation of
                                           cancer biomarkers. Specifically, PBG has been involved in the following translational cancer research
Multi-centre studies to clinically validate:
the cancer biomarkers uPA and PAI-1 (recommended by the ASCO breast cancer consensus panel for
their clinical utility in early breast cancer patients, J Clin Oncol 2007; 25:5287-5312) as risk selection
criteria in node-negative breast cancer patients and compare their predictive role with that of clinico-
pathological factors;
the Rotterdam 76-gene profile for lymph node-negative breast cancer patients, the first including
untreated node-negative patients, the second including patients that have received adjuvant Tamoxifen
Development of “in vivo proof-of-concept” for the role of the matrix metalloprotease inhibitor TIMP-1
in the treatment of colon cancer and prospective studies aimed at evaluating the clinical significance
of plasma TIMP-1 as a marker for early recurrence in colorectal cancer patients; studies on plasma
TIMP-1 as a marker for minimal residual disease in colorectal and breast cancer and development of
specific TIMP-1 assay test kits.
Participation in several genomic and proteomic projects on different cancer types to challenge gene
signatures and epigenetic biomarkers with patient’s prognosis and response to chemo/endocrine
therapy.                                                                                                     135
Studies on the DNA-methylation profile of CpG islands within promoter regions of candidate genes in
breast and brain tumours of patients treated with different types of adjuvant endocrine/chemotherapy;
DNA-methylation status and stratified therapy in glioblastoma.

Treatment-related activities:
ex vivo investigations of mechanisms and patterns of chemoresistance in tissue and blood components
of patients with lung cancer or melanoma (;
cytoskeleton and paclitaxel sensitivity in breast cancer: the role of beta-tubulins;
studies on hormone independence implying angiogenesis (adrenomedullin, TP/PDECGF) associated to
TK, HER1, HER2, and other signalling pathway components;

                                                                                                             3. EORTC Current Research and Strategies
development of surrogate markers to determine effect of uPA inhibitors applied to humans (www.;
small molecule targeting of heat shock protein 90 chaperone function: rational identification of a new
anticancer lead.
Task force on micrometastasis: evaluation and standardization of new technologies for the detection
and characterization of micrometastases, demonstration of usefulness of prognostic/predictive
screening for micrometastatic cells in bone marrow/blood of cancer patients plus detection of
circulating tumour cells in the peripheral blood of breast cancer patients.
Application of novel antibody-coated Seldinger guide wire nanodetectors and antibody-coated bead
systems (CellSearch, Adnagene) to track and enrich circulating tumour cells in vivo (www.gilupi.
                                           Activation and participation in several retrospective studies to investigate the clinical significance
                                           of novel biomarkers of proliferation, hypoxia, angiogenesis, cell survival (apoptosis and telomere
                                           maintenance mechanisms) on different tumour types.
                                           Identification of putative breast cancer stem cell markers and assessment of the reliability of highly
                                           tumorigenic breast cancer cell cultures as tools to investigate the activity of conventional and
                                           investigational new drugs.

                                           Projects / Strategies for the coming years

                                           The PGB aims at reviewing tumour tissue specimens coming from cancer patients within EORTC
                                           clinical trials, and as a translational research aspect, conducting research and teaching in the life science
                                           area with a focus on detection, characterization, determination, and potential clinical application of
                                           cancer biomarkers, associated with cancer disease progression and cancer metastasis. In particular,
                                           markers are studied which provide information about:
136                                        •

                                           • prognosis;
                                           • selection of therapy;

                                           • monitoring of treatment response and side effects;

                                           • assessment of individual risk;

                                           • detection of micrometastases;

                                           • molecular basis of carcinogenesis in specific tissues;

                                           • identification of biologically / clinically relevant molecular targets for new therapies.

                                           Within the PBG, guiding principles are provided and discussed on how to inform physician scientists
                                           and cancer researchers about quality control systems to enable a consistent assessment of the clinical
                                           value of cancer biomarkers. A fundamental knowledge of the methodology of tumour tissue or blood
                                           sample collection and storage, tissue processing, assay methods, reference materials, and standard
                                           operation procedures (SOPs) is often lacking. Therefore, the PBG advises on methodologies, test
                                           kits, and test reagents to be utilized for tumour biomarker determinations. Providing information to
                                           basic and clinical scientists and teaching good laboratory and statistical practice is a major task of
3. EORTC Current Research and Strategies

                                           the PBG.
                                           To improve translational research cooperation within EORTC (pre)clinical trials, the PBG intends to
                                           organize joint meetings with several of the disease oriented EORTC groups (DOGs) and also plans to
                                           do this within the context of NOCI. The PBG will also be more actively engaged in the translational
                                           cancer research component of EORTC clinical trials (N.B. PBG members are also members of TRAC).
                                           The PBG is willing to take an active part in advising the disease-oriented EORTC groups regarding
                                           tissue/blood storage and handling, cancer biomarker assessment, standard operating procedures,
                                           biochemical/cellular methodologies and technologies, as well as good laboratory practice, quality
                                           assessment, and quality assurance. Also, a closer collaboration with the EORTC PAMM Group and the
                                           newly created Imaging Group is envisioned in the direction of joint cancer biomarker research at the
                                           genetic, proteomic, and functional levels.
The PBG strongly encourages young scientists/clinicians to become active PBG members in order
to guarantee continuity within the group and to train these new members in the field of cancer
biomarker investigation and clinical oncology.

Quality Assurance

Since 1979 the PBG Quality Assurance (QA) centre (Nijmegen) has a long-standing experience
in performing QA studies on cancer biomarkers both within and outside of the EORTC. This still
represents an important task of the PBG and includes quality assessment and assurance of the
reagents and test systems employed and pre-analytical processing and commercial kits for existing
markers and of the equipment used to quantify the biomarker content in tumour tissue extracts or
other body fluids.
Currently, owing to rapid gene profiling activities, tumour-associated biomarkers in tissues or body
fluids are also becoming increasingly important for their use in clinical decision making. Thus, the
repertoire of potential biomarkers is increasing steadily as is the variety of methods used for their
measurements, even though standardization and quality control of these measurements is often                   137
lacking as are guidelines for the interpretation of results. This is not always evident to the clinicians or
the basic scientists, and even worse, assay results from unvalidated biomarker studies are repeatedly
being made available to the public in scientific publications. To set up guidelines and to inform the
medically trained cancer researcher are high priorities of the PBG.
The PBG regularly advises on common methodologies for tumour biomarker assays and ensures
that appropriate external quality assessment schemes are available. As most cancer trials involve
multi-centre co-operation, special emphasis by the PBG is put on the quality and performance of the
assays, on their reproducibility, and on the collaboration with clinical groups of the EORTC, European
Commission, Health Authorities, and other national and international bodies that have scientific and
social interest in the supply of optimal information about the quality and performance of tumour
biomarker tests and their relevance for cancer patient management. PBG is also prepared to assist in
the development of guidelines regarding tissue banking.
The PBG will therefore continue to:

                                                                                                               3. EORTC Current Research and Strategies
• focus attention on biomarker development and clinical implementation;

• support high-level quality assurance programs when assessing cancer biomarkers;

• set up SOPs for assessment of cancer biomarkers;

• enforce interaction with the EORTC-DOGs.

Translational Research

The PBG does not conduct EORTC sponsored clinical trials on its own but attempts to perform
cancer biomarker studies on clinical materials (tissue and body fluids) obtained from clinical EORTC
groups as part of EORTC clinical studies and, within those trials, is involved in quality assessment and
quality assurance measures.
                                           Physician scientists, pathologists, clinical chemists, basic scientists (i.e., molecular and cell biologists,
                                           biochemists), and statisticians representing different European clinical and/or research centres,
                                           including the EORTC NOCI, are working closely together to conduct and facilitate translational
                                           cancer research.
                                           Within this scenario, the PBG is conducting or taking part in several tasks.
                                           Harmonization of pathology review across EORTC trials plus collaboration in the organisation and
                                           maintenance of physical and virtual tumour banks with specimens from cancer patients enrolled in
                                           clinical trials and associated clinico-pathologic databases.
                                           Quality assessment/assurance of the reagents and test systems employed to quantify the biomarker
                                           content in tumour tissue extracts and body fluids.
                                           Development of internal and external reference materials for tumour biomarker assays plus writing
                                           and communication of SOPs on specimen handling and processing.
                                           Transnational research multi-centre studies to validate gene signatures (multiplex cancer biomarker
                                           panel) and cancer biomarkers predicting disease progression and/or treatment response/failure in
138                                        patients with solid malignant tumours.
                                           Handling of legal issues related to tissue and blood collection.
                                           Participation in EU-FP6 and EU-FP7 cancer projects.

                                           Collaboration with other groups (EORTC & Others)

                                           In the EORTC: a strong collaboration of individual PBG members with members of the EORTC pre-
                                           clinical groups (PAMM and Imaging Group) is ongoing and mainly encompasses research activities
                                           regarding signal transduction pathways and metabolic activity of cancer therapeutics. Moreover, PBG
                                           members participate actively in several EORTC Clinical Groups, including the Brain Tumour, Breast
                                           Cancer, Gastrointestinal Tract Cancer, Genito-Urinary Tract Cancer, Gynaecological Cancer, Head and
                                           Neck Cancer, Lung cancer, Soft Tissue and Bone Sarcoma, Melanoma and Radiation Oncology Groups
                                           to facilitate basic and clinical exchanges and to enforce translational cancer research.
3. EORTC Current Research and Strategies

                                           Outside the EORTC: PBG members participate actively in several non-EORTC Groups/Societies,
                                           including EGTM, NCI and EDRN, ISOBM, GBG, IPS, ISFP, BIG, TRANSBIG, ASCO, and AACR.
                                           PBG members are organizing and actively participating in the annual EORTC-NCI-ASCO (ENASCO)
                                           meetings on molecular markers in Brussels and in the USA.
Pharmacology and Molecular
Pharmacology Molecular
            and            Gr
Mechanisms Group Mechanisms oup
Structure of the Group

Chair                                         G.J. Peters, Amsterdam (NL)
Secretary                                     E. Chatelut, Toulouse (FR)
Treasurer                                     A.K. Larsen, Paris (FR)
Chair, Drug Discovery Committee               A.M. Burger, Detroit (US)
Chair, Functional Imaging Committee           O. Hoekstra, Amsterdam (NL)

Steering Committee

I. Fichtner, Berlin (DE)
F. Gieseler, Lubeck (DE)
D. Jodrell, Cambridge (UK)                                                                            139
E. Raymond, Paris (FR)
J. Robert, Bordeaux (FR)
A. Skladanowsky, Gdansk (PL)
A. Westwell, Cardiff (UK)
Young Oncologist/Scientists                   S. Faivre, Paris (FR)
                                              A. Westwell, Cardiff (UK)
The aim of the Pharmacology and Molecular Mechanisms (PAMM) Group is to stimulate research in
Europe in the fields of pharmacology, pharmacokinetics, pharmacodynamics, pharmacogenetics and
pharmacogenomics, and on the molecular mechanisms of anticancer drug effects and drug-related
molecular pathology.
In addition, the PAMM Group serves as a master organisation for other EORTC groups, such as the
former Screening and Pharmacology Group (SPG) which now fully operates as the Drug Discovery

                                                                                                      3. EORTC Current Research and Strategies
Committee (DDC).

Recent Achievements

The annual scientific Winter meetings of the Group were held in January 2008 in Palermo and in
March 2009 in Brussels as a pre-EGAM meeting. During the Palermo meeting representatives of
the PathoBiology group were invited to give an overview of their activities in order to see whether
more interactions could be developed. During the PathoBiology group meeting in Milan in September
2008, representatives of the PAMM presented their views. The interaction was intensified during the
2009 EGAM meeting. In addition to the successful PAMM meeting (also attended by various non-
PAMM EORTC members), the joint session with the PAMM-PathoBiology and Functional Imaging
Committee was very successful as well. It was felt that this meeting will serve as a good basis for
further interactions with several clinical groups.
                                           During the DDC meeting in Brussels the achievements of the committee were discussed in order
                                           to better position the group within the EORTC. During its existence (earlier as the SPG group)
                                           several drugs have been developed, gone into the clinic, and are now part of the therapeutic arsenal;
                                           a well-known example is temozolomide. The NCI-EORTC drug screening initiative provides a unique
                                           evaluation platform in Europe for characterization of novel chemical entities (NCE).

                                           Projects / Strategies for the next years

                                           Future strategy is to link the PAMM Group activities more closely to the activities of EORTC disease-
                                           oriented groups.Various initiatives from both the PAMM Group and the disease oriented groups were
                                           undertaken during the EGAM meeting. In this context, PAMM promoted the membership of young
                                           clinical investigators with interest in translational research to become members of PAMM. PAMM is in
                                           a unique position, since it provides valuable drug expertise next to the traditional pathology directed
                                           expertise of most translational research officers of the disease oriented groups. This not only enables
                                           the performance of drug monitoring but also the evaluation of pharmacodynamic events in relation
                                           to pharmacogenomics. These analyses as well as polymorphisms have already provided the basis for
                                           tailored therapy designed to give the right drug at the right time to the right patient. Together with
                                           the imaging technology expertise of the Imaging Group, this will give invaluable support to clinical
                                           The PAMM Group with its DDC forms a large reservoir of expertise for optimizing drug development
                                           and will be of invaluable help for EPOD, the Translational Research Advisory Committee (TRAC),
                                           as well as the New Drug Advisory Committee (NDAC). A good integration of these activities will
                                           optimize the identification, evaluation, and development of novel anticancer agents at an early phase,
                                           but also when they enter large randomized Phase III trials.

                                           Collaborations with other groups

                                           Within the EORTC Network
3. EORTC Current Research and Strategies

                                           Collaborations with Translational Research Division (Pathobiology Group, Imaging Group) and
                                           Clinical Research Division (Soft Tissue and Bone Sarcoma Group, Lung Cancer Group, Lymphoma
                                           Group, Cancer in the Elderly Task Force, and Radiation Oncology Group) groups have already been

                                           Outside the EORTC Network
                                           Collaborations exist with the Southern Europe New Drug Organization (SENDO) and Central
                                           European Society for Anticancer Drug Research – EWIV (CESAR). The PAMM Group is also
                                           represented in the Executive Committees of several international organizations focused on specific
                                           drugs or groups of compounds. Moreover, the DDC has close links with the NCI, who regularly
                                           attends the DDC meetings.
Quality of Life Group
Structure of the Group

Chair                                                        G. Velikova (UK)
Joint Secretaries                                            J. Ardill, Belfast (UK)
                                                             F. Efficace, Rome (IT)
Treasurer                                                    T. Young, London (UK)
Module Development Committee                                 C. Johnson Southampton (UK)
Translation Committee                                        M. Koller, Regensburg (DE)
Newsletter Editor                                            M. Taphoorn, Den Haag (NL)
Young Scientist                                              F. Efficace, Rome (IT)
Quality of Life Department Representative                    A. Bottomley, Brussels (BE)

Recent Achievements

The EORTC Quality of Life Group (QoL Group) is a multidisciplinary group including oncologists,
surgeons, radiotherapists, nurses, behavioural scientists, psychometricians and statisticians. A central
activity of the group is the development of a modular system for assessing the health-related quality
of life (HRQoL) of patients with cancer for use in clinical trials and potentially in clinical practice. This
modular system includes a core questionnaire, the EORTC QLQ-C30, and a range of supplementary,
disease-specific and/or treatment-specific questionnaire modules. Several recent systematic reviews
have indicated that the QLQ-C30 is the most widely used HRQoL questionnaire in randomised
clinical trials, with the original JNCI publication reporting on the development and international
psychometric testing of the questionnaire being cited more than 1,500 times in the journal literature.
The modular assessment system has been expanded to include a wider range of issues of importance

                                                                                                                3. EORTC Current Research and Strategies
to cancer patients, including their information needs, satisfaction with care, and spiritual well-being.

Module development
Eleven internationally validated questionnaire modules are currently available for patients with lung,
breast, head & neck, multiple myeloma, oesophageal, gastric, oesophago-gastric cancers, colorectal
cancer liver metastases, prostate cancer, ovarian cancers, and for assessing satisfaction with inpatient
care. A 15-item version of the core QLQ-C30 questionnaire, the QLQ-C15PAL has been developed
for use with patients in the palliative care setting. This has been accomplished using item response
theory techniques. A major advantage of this approach is that it allows one to generate scores for the
QLQ-C15-PAL directly comparable with those obtained when using the full QLQ-C30.
                                           Fifteen other modules are provisionally approved and may be used with the understanding that their
                                           psychometric evaluation has not yet been completed (examples include brain, pancreatic, bladder
                                           cancer, bone metastases, colorectal cancer, ophthalmic module, gastrointestinal neuroendocrine
                                           tumours, chronic lymphocytic leukaemia, hepatocellular carcinoma, peripheral neuropathy, high-
                                           dose chemotherapy, and information needs). Thirteen modules are in earlier stages of development,
                                           including those assessing fatigue, radiation proctitis and breast reconstruction, nasopharyngeal,
                                           testicular, endometrial cancer, cholangiocarcinoma, oral health module, spiritual well-being, and cancer
                                           in the elderly.
                                           The core questionnaires and the modules are available to academic users free of charge. A fee is
                                           payable for commercial users from pharmaceutical industry. The income funds the groups’ research,
                                           further module development, and translations for academic use.

                                           Quality Assurance

                                           The process of module development is described in detail in a manual that provides step-by- step
142                                        procedures from early development through international field testing. Methodology incorporates
                                           significant input from patients and health-care professionals at every stage of development. Continuous
                                           peer review is carried out by the Module Development Committee.Translations of questionnaires into
                                           more than 60 languages are conducted via rigorous, standardized, forward-backward procedures, and
                                           are coordinated by the EORTC Quality of Life Department in Brussels. A translation guidelines manual
                                           provides detailed information on the translation process. Each step in both the module development
                                           and the translation process requires written documentation and approval by the QoL Group.
                                           To ensure proper use of the questionnaires developed by the group, a user’s manual is available
                                           including scoring instructions and syntax files for commonly used statistical software programmes.
                                           The scoring manual has recently been updated. The group also has generated a guidance manual for
                                           the conduct of clinical trial based HRQoL investigations. All of these manuals (known as “blue books”)
                                           are available on CD-ROM and for download from the QoL Group website.

                                           Other projects and future research
3. EORTC Current Research and Strategies

                                           Cross-cultural analysis of EORTC QLQ-C30. The cross-cultural analysis (CCA) project, led by
                                           Peter Fayers (Aberdeen, Scotland), continues to publish new work. The project has assembled a
                                           unique dataset consisting of responses to the EORTC QLQ-C30 questionnaire representing over
                                           100 separate studies and including data for over 35,000 respondents in over 40 countries. The
                                           original project publications, which used differential item functioning (DIF) analyses, identified several
                                           instances of differential response to particular items of the EORTC QLQ-C30 due to either the item
                                           translation or to cultural reasons. Further published work on the pattern of these DIF results over
                                           three time points (pre-treatment, on-treatment and off-treatment) has shown that similar results are
                                           generally found regardless of the treatment status of the respondent.
The project has undertaken a variety of methodological work. One published article has examined
which geographic/cultural groups place the most emphasis on different aspects of their HRQoL. A
further article has used computer simulations to determine the performance of differential item
functioning analyses in the HRQoL context and to advise on the necessary sample size for future
studies. We have prepared a literature review of differential item functioning as applied to HRQoL
studies, have developed guidelines on how to assess the practical impact of differential item functioning
analyses in the context of clinical trials, and are investigating the response choice translations used in
the EORTC QLQ-C30.
The CCA project database was used to update the EORTC QoL Group Reference Values manual,
which has now been published on the EORTC Quality of Life Department website. This provides
typical values of the EORTC QLQ-C30 subscales for each cancer site.
The CCA database is being used for the new “higher order factors” project. This new project (lead
by Neil Aaronson and Chad Gundy, Amsterdam, The Netherlands) is intended to develop (and test
the suitability of) an algorithm for computing factors, which will summarize the 15 dimensional profile
generated by the 30-item EORTC QLQ-C30 questionnaire into a small number of summary scales.
Having a small number of HRQoL outcomes can be quite useful in clinical trials and may facilitate
sample size calculations and avoid multiple testing in statistical analysis of HRQoL outcomes. During        143
the first phase of this project, 10 theoretical models were identified and applied to a sub-sample of
the data using confirmatory factor analysis. The “goodness of fits” of those models to the data were
examined and were compared to each other. One (or two) candidate model(s) will be selected on the
basis of a combination of statistical, theoretical, clinical, and pragmatic arguments. The selected model
will then be cross-validated on a second sub-sample, and in a third sub-sample its parameters will be
examined for equivalence over various sub-populations. The final model will be used as the basis for
computing the “summary factors”.

Computer-adaptive tests for EORTC QLQ-C30
This project aims to generate a dynamic, computer-adaptive version of the EORTC QLQ-C30 based on
modern psychometric theory and techniques. The basic idea of computer-adaptive testing (CAT) is to
tailor the questionnaire to the individual respondent. Based on the responses to the preceding items

                                                                                                             3. EORTC Current Research and Strategies
it is estimated which item should be asked next to obtain maximal information on that individual’s
HRQoL (symptom level, functional status, etc.). Basing the CAT on item response theory methods
allows comparison of scores directly between individuals even though they may have answered
different sets of items (from the same item pool). CAT has several advantages, including increased
precision using the same number of items (smaller samples required), reduced questionnaire length,
reduced floor and ceiling effects, and avoidance of non-informative questions.
This project continues under the leadership of M. Groenvold and M. Petersen, Copenhagen, Denmark.
Presently, item pools are being developed and tested for 14 of the 15 quality of life domains addressed
in the QLQ-C30. We anticipate that, following the development of a CAT version of the QLQ-C30,
CAT versions of a number of the supplemental questionnaire modules will be generated as well.
Additionally, future work may expand the measurement system to include a branching system for
collecting more detailed information on patients’ symptoms and functioning once threshold levels of
symptoms and/or functional impairment have been reached.
                                           Ultimately, computer-adaptive questionnaires will improve the measurement of HRQOL in clinical
                                           trials, making it briefer, more relevant to patients, and more sensitive to differences and changes over
                                           Health-related quality of life of mid- to long-term survivors of testicular and prostate cancer from
                                           EORTC Phase III clinical trials
                                           It has been estimated that there are currently more than 10 million cancer survivors, and large cohorts
                                           of patients enjoy disease-free survival of 5 years or longer. There is increasing interest worldwide in
                                           evaluating the longer term impact of cancer and its treatment. To better understand the physical,
                                           functional and psychosocial health problems and needs of cancer survivors, we need to supplement
                                           the currently available health-related quality of life (HRQoL) measures with questionnaires specifically
                                           designed for the period of cancer survivorship.
                                           The objectives of this research are twofold: (1) to develop and test the logistics required to conduct
                                           survivorship studies within the context of the EORTC with specific focus on long-term follow-up
                                           of patients treated in phase III clinical trials, and (2) to translate and pilot test questionnaires for
                                           assessing the HRQoL of mid- to long-term cancer survivors (> 5 years disease free). These objectives
144                                        will be reached by conducting two interrelated pilot studies.
                                           In pilot study 1, we will identify and attempt to resolve ethical and logistical problems in conducting
                                           HRQoL survivorship studies that arise at both the centrally (EORTC Headquarters) and locally
                                           (individual participating centres). This will be accomplished by focusing on two trials – one in prostate
                                           cancer and one in testicular cancer. All steps involved in obtaining central and local permission to
                                           conduct a survivorship survey, in identifying patients who are alive and disease-free via local medical
                                           records, in obtaining contact details, and in obtaining written informed consent from patients, will be
                                           carried out for these two trials.
                                           In pilot study 2 we will investigate a measurement model for assessing the HRQoL of cancer survivors
                                           at 3 levels: (1) generic, (2) cancer-specific, and (3) cancer survivor-specific. At the generic level, we
                                           will make use of the SF-36 Health Survey. At the cancer-specific level, we will make use of the EORTC
                                           QLQ-C30 plus the EORTC prostate cancer module, the QLQ-PR25, and the EORTC testicular
                                           cancer module. At the survivorship-specific level, we will make use of the Impact of Cancer (IOC)
                                           Questionnaire and SF-36. The questionnaire battery will be administered to a sample of 25 testicular
3. EORTC Current Research and Strategies

                                           and 25 prostate cancer survivors in each of 5 countries (Belgium, Italy, Norway, the Netherlands, and
                                           the United Kingdom, for a total N = 125 testicular and 125 prostate cancer survivors).
                                           This project will generate practical and ethically acceptable procedures for recruiting patients
                                           from EORTC clinical trials for long-term HRQoL survivorship studies, and will evaluate an HRQoL
                                           assessment package including generic, cancer-specific and survivor-specific questionnaire elements.
                                           This project will lay the groundwork for a series of future, substantive studies on the cross-cultural
                                           differences in the survivorship experience of cancer patients.
Collaboration with other groups (EORTC and others)

Collaboration with other EORTC clinical groups in implementing quality of life as an outcome
measure in clinical trials is ongoing. This collaboration is led by the Quality of Life Department and
its Director, A. Bottomley, with participation of experts from the QoL Group contributing to specific
trials. Examples of such successful collaborations include the Brain Cancer Group (M Taphoorn, The
Netherlands) and the Gynaecological Cancer Group (E Griemel, Austria). These collaborations have
generated interesting trial results furthering our knowledge of treatment impact on quality of life of
cancer patients and contributing to evidence-based changes in clinical practice.
The QoL Group works with the EORTC Task Force for Cancer in the Elderly towards the development
of a HRQoL assessment for older people with cancer.This has been facilitated by formal representation
of the QoL Group at the Task Force meetings (C. Jonhson, UK).
Another collaborative project is with EORTC Leukaemia Group looking at patient-reported quality
of life and symptoms in myelodysplastic syndromes (MDS). The project is led by one of our young
investigators, F. Efficace, Italy. The study aims at providing the scientific community with additional
data to support and facilitate clinical decision-making process in patients with MDS. The project          145
investigates the prognostic significance of patient-reported outcomes for survival and the prospective
assessment of HRQoL. It will establish reference data for the EORTC QLQ-C30, which are currently
lacking for this population, will investigate patients’ preferences for actual involvement into clinical
decision making, and will help in identifying those patients who would benefit most from a shared
decision-making approach.
The QoL Group continues to collaborate with the National Cancer Institute Canada (NCIC) on
various HRQoL-related activities. The NCIC is represented in the QoL Group by the chair of the
NCIC Clinical Trials Group Quality of Life Committee. The QoL Group also has continuing links
with the UK Medical Research Council for the conduct of intergroup clinical trials in which HRQoL
outcomes are being assessed.

                                                                                                           3. EORTC Current Research and Strategies
                                           Radiation Oncology Group
                                           Structure of the Group

                                           Chair                                        V. Grégoire, Brussels (BE)
                                           Secretary                                    P. Poortmans Tilburg (NL)
                                           Treasurer                                    P. Maingon, Dijon (FR)
                                           NOCI Liaison                                 G. van Tienhoven, Amsterdam (NL)
                                           QA Officers                                  E. Aird, Northwood (UK)
                                                                                        P. Poortmans, Tilburg (NL)
                                                                                        C. Hurkmans, Eindhoven (NL)
                                           Administrator                                F. Godson, Lausanne (CH)

                                           Steering Committee
                                           Executive Board
                                           Committee chairs (Publications, Membership, Website)
                                           Working Party Coordinators
                                           Radiation Technologists’ Section chair
                                           EORTC HQ Team
                                           Young Oncologist: E. Dieleman, Amsterdam (NL)
                                           QA Manager at EORTC HQ


                                           Membership                                   F. van den Bergh, Groningen, (NL)
                                           PR and Website                               A. Kuten, Haifa (IL)
                                           Quality Assurance                            E. Aird, Northwood (UK)
3. EORTC Current Research and Strategies

                                           Publications                                 D. Weber, Geneva (CH)

                                           Working party coordinators

                                           Brain Tumours                                D. Weber, Geneva (CH) & S. Erridge, Edinburgh (UK)
                                           Head and Neck                                W. Budach, Düsseldorf (DE)
                                                                                        J. Langendijk, Groningen (NL)
                                           Breast                                       A. Kuten, Haifa (IL) & H. Westenberg, Arnhem (NL)
                                           Lung                                         C. Le Péchoux, Villejuif (FR)
                                           GI                                           O. Matzinger, Lausanne (CH)
                                           GU                                           C. Scrase, Ipswich (UK)
                                                                                        F. van den Bergh, Groningen (NL)
QA Team

E. Aird, Northwood (UK)
R. Bar-Deroma, Haifa (IL)
F. Duclos, Lausanne (CH)
C. Hurkmans, Eindhoven (NL)
O. Matzinger, Lausanne (CH)
A. Monti, Como (IT)
P. Poortmans, Tilburg (NL)
G. van Tienhoven, Amsterdam (NL)
The EORTC Headquarters Team
Radiation Technologists Section (RTT) - Chair: F. Duclos, Lausanne (CH)
Scientific Board                                M. van Os, Rotterdam (NL)
                                                H.-P. van der Laan, Groningen (NL)
                                                V. Lengkeek, Bern (CH)
                                                B. Pastoors, Geneva (CH)                                  147

Recent Achievements

• Completion of EORTC 22952-26001: No radiotherapy versus whole brain irradiation (WBI) after
surgical resection or radiosurgery of 1 to 3 brain metastases from a solid primary tumour (R-P. Müller,
M. Kocher, R. Soffietti). The study ran from November 1996 to November 2007 and accrued 359
patients from 26 centres. The primary endpoint was time to deterioration of WHO performance
status to WHO >2, with secondary end points OS, PFS, time to intra/extracranial progression,
QoL. Patients having had local treatment for brain metastases were randomized to have WBI or no
irradiation. There was no significant difference for survival with PS ≤2 (p>0.1), also no significant
difference for overall survival. There was a longer progression free survival with WBI with significant
reduction of intracranial progression in previous and new sites. An abstract has been accepted for
oral presentation at ASCO 2009.

                                                                                                          3. EORTC Current Research and Strategies
• Completion of EORTC 22003/08004/PCI99: International Prophylactic Cranial Irradiation Trial.
Randomized trial of standard dose vs. higher dose prophylactic cranial irradiation (PCI) in limited
stage small cell lung cancer (SCLC) complete responders (CR) - C. Le Péchoux. This intergroup
study ran from September 1999 to December 2005 and accrued 720 patients from 157 centres in 22
countries. The EORTC ROG and Lung Cancer Group contributed 223 patients.
                                           The primary endpoint was incidence of brain metastases at 2 yrs median follow up and the aim of
                                           the study was to demonstrate an absolute decrease of 15% in the 36 Gy arm versus the 25 Gy arm
                                           (from 40% to 25%). The median follow-up is 3.2 years. There was a non-significant decrease in brain
                                           metastases incidence at higher RT doses, but survival was worse in the high dose arm: overall survival
                                           was 37% vs. 42% in the 25 Gy arm. The reasons for this poorer survival in the high dose arm could
                                           be an imbalance in the modalities of CT-RT (suboptimal RT techniques, sequencing of CT-RT, time
                                           between start and end of RT) or it could just be a false positive result. It can be concluded that PCI
                                           with a total dose of 25 Gy remains the standard of care in limited-stage SCLC.
                                           • Analysis of acute toxicity and radiation parameters in EORTC 22991: (Three dimensional conformal
                                           radiotherapy / intensity modulated radiotherapy alone vs. three dimensional conformal radiotherapy
                                           / intensity modulated radiotherapy plus adjuvant hormonal therapy in localized T1b-c, T2a, N0, M0
                                           prostatic carcinoma. A Phase III randomized study - O. Matzinger, F. Duclos, M. Bolla. This study, closed
                                           in April 2008, recruited 819 patients. Participating centres had to select one total dose option: 70,
                                           74 or 78 Gy (2 Gy/fx/day, 5 d/wk) for all their patients. Organs at risk were clearly defined in the
                                           protocol with their dose constraints. No recommendations were made with regard to bladder
                                           or rectum filling. A fairly extensive form for RT QA was designed to gather supplementary data
148                                        on treatment volumes. This toxicity analysis concerns 791 of the 819 patients randomized (having
                                           received at least 60 Gy, with documented radiotherapy, acute toxicity and RT QA form), with three
                                                     ▫ Worst grade of acute toxicity by RT dose and technique
                                                     ▫ Influence of RT QA dosimetric parameters on the risk (and time to occurrence) of GI
                                                        and GU toxicity
                                                     ▫ Correlation of treatment planning parameters (volume, total dose, technique) with RT
                                                        QA dosimetric outcome parameters.
                                           Results show that 3D-CRT/IMRT up to 78 Gy is well tolerated. The planning of 3D treatments at 70
                                           Gy seems to have been suboptimal (higher toxicity was observed), while IMRT at 78 Gy also caused
                                           increased toxicity. Dmax-bladder and D50%-rectum were related to the risk GU and GI toxicity,
                                           respectively (within the constraints of the protocol treatment specifications). IMRT improves D50%
                                           rectum and Dmax-bladder, however, volumes of more than 400 cc for 3D-RT and the dose of 78
                                           Gy, even for IMRT, seem to negatively affect those QA RT parameters which in turn, are related to
3. EORTC Current Research and Strategies

                                           increased risk of toxicity. Weekly recording of toxicity appears superfluous since it places a heavy
                                           burden on participating sites. A full paper on this analysis is in preparation.
                                           • Analysis of early toxicity (up to year 3) and radiation parameters in EORTC 22922/10925: phase III
                                           randomized trial investigating the role of internal mammary and medial supraclavicular (IM-MS) lymph
                                           node chain irradiation in stage I-III breast cancer - O. Matzinger, L. Collette, I. Heimsoth, P. Poortmans.
                                           A total of 4004 patients were entered in this study between July 1996 and January 2004. The first
                                           analysis of the primary endpoint (OS at 10 yrs) is expected in 2012. This toxicity analysis concerns
                                           3866 (97%) of the total recruitment, reported up to 3 yrs after treatment (change in PS at year 3). It
                                           can be concluded that the treatment was well tolerated with low toxicity rates during the first 3 years
                                           and without any impairment of the PS. Longer FU is needed to further document cardiac toxicity and
                                           the impact of IM-MS irradiation on clinical outcome.
Projects / Strategies for the coming years

The specific role of the ROG lies in studying the fundamental questions related to optimal loco-
regional treatments leading to maximal loco-regional control and survival rates while minimizing
mutilation and side effects.
Our emphasis, on the one hand, is on the design of randomized phase III trials aimed at answering
a clinical question which directly contributes to the definition of new standards of care, and on the
other hand, it is on carefully selected phase II studies in rare tumour types such as sarcoma.

Currently we have a number of possible new trials under development:
• A phase III study in postoperative radiation of head and neck cancer. Preliminary plans for a further
study on adjuvant treatment of non-resected cases have been discussed as well.
• A new phase II/III study in locally advanced, high risk prostate cancer.
• New studies in glioma in collaboration with the Brain Tumour Group are in the process of being           149
opened: the use of temsirolimus in non-methylated glioblastomas, temozolomide and radiation therapy
in elderly glioblastoma patients, temozolomide and radiation therapy in anaplastic glioma, investigation
of the use of PET/CT-MRI in re-irradiation of recurrent gliomas and temozolomide and radiation
therapy in anaplastic oligodendroglioma and anaplastic mixed glioma.
• The CENTRIC study on the use of cilengitide in combination with standard treatment for glioblastoma
patients with methylated MGMT gene promoter is in the process of initiation world wide.
• A phase II study has just opened on atypical and malignant meningioma.
• It is hoped to be able to join the TROG-led study on DCIS when funding issues have been
• A new US-led study on pancreas cancer is under development and it is hoped that the EORTC ROG
will be able to join.
• Further development of the IMAGE protocol (Imaging in Gastro-Esophageal cancer).

                                                                                                           3. EORTC Current Research and Strategies
• A project on anal cancer (PARADAC) will be completed. This is a joint project concerning all more
or less recent anal cancer studies out of which it is hoped to plan future work in this area.
Our aim is to integrate translational research and where applicable functional imaging into all new
studies as this may permit a fundamental advance in the understanding of a particular disease.
                                           Quality Assurance

                                           The ROG QA Team is involved in evaluation of submitted Facility Questionnaires (FQ) and review of
                                           external reference dosimetry audit results, also providing advice and support in the development of
                                           protocol descriptions for all new studies involving radiotherapy together with the accompanying case
                                           report forms. The QA Team is also involved in the evaluation of dummy run procedures and in the
                                           retrospective review of treatment of trial cases.
                                           A special dedicated Facility Questionnaire was developed for use by non-EORTC centres participating
                                           in the Merck study on the use of Cilengitide in glioblastoma (CENTRIC). Up to now, a total of 208 of
                                           these questionnaires has been evaluated and validated (of the 234 submitted) by the ROG QA Team.
                                           With the initiation of the malignant meningioma study (22042) and the collaboration with the ATC
                                           in the US, the on-line review of dummy run procedures has been started. It is hoped that this
                                           procedure will now be possible via the EORTC through the use of the new review platform for quality
                                           assurance (VODCA), which was recently acquired and which will become the norm in all studies with
                                           radiotherapy. Patient data will be uploaded by the participating centres for review/validation by a
150                                        member of the QA Team.
                                           The QA Team is increasingly involved in the development of new studies, also those of the disease-
                                           oriented groups, where radiotherapy is part of the treatment. New procedures have been written to
                                           streamline protocol development which have been endorsed by the EORTC Executive Committee.
                                           The Emmanuel van der Schueren Fellow (for Quality Assurance in Radiation Therapy, supported by
                                           the Vlaamse Liga tegen Kanker, Belgium) has been extremely active in the increasing number of tasks
                                           in the area of QA in RT and a number of publications on this work will be appearing during 2009. A
                                           new fellow has been appointed for the next term.

                                           Translational Research

                                           In ROG-led studies translational research activities are aimed at:
3. EORTC Current Research and Strategies

                                           • The study of the impact of 1p deletions in low grade glioma and the prognostic effect of these
                                           deletions on progression-free survival in each treatment arm;
                                           • The correlation of molecular characteristics of tumour tissue from malignant meningioma with the
                                           natural history of the disease and with the patient’s response to radiation therapy;
                                           • The identification of key molecular pathways for the future identification of patients most likely to
                                           benefit from radiation therapy in breast cancer, including the search for pharmacogenetic markers of
                                           • To assess the late treatment effects and prediction of lung toxicity – also important for patients
                                           receiving radiation therapy to the lungs in the treatment of breast cancer, lymphoma, and oesophageal
• The correlation of intrinsic radiosensitivity with outcome of treatment in the postoperative
treatment of head and neck cancer. This particular project has won a prize at the 2009 EGAM and
will receive funding by the EORTC.
The methods used for these various tasks include the construction of micro-arrays, genotyping, and

Radiation Technologists’ Section

Achievements, projects and objectives within the ROG.
The board consists of
Chair                                            F. Duclos, Lausanne (CH)
Secretary                                        B. Pastoors, Geneva (CH)
Projects Supervisor                              B. Speleers, Gent (BE)
                                                 G. Gleeson, Galway (IE)
Scientific Supervisors                           H.P. van der Laan, Groningen (NL)
                                                 M. van Os, Rotterdam (NL)                                  151
The RTT section has been putting efforts into building a European network of RT Technologists.
According to their specific field of expertise, RT Technologists are asked to participate in projects and
to review trial protocols. For this purpose, F. Duclos, as Chairman, regularly reports on the section’s
activities at international meetings.
Parallel to the regular Radiation Oncology Group (ROG) meetings, the RTT Section organizes
international symposia, with specific topics, such as recently in 2008 in Leuven (Positioning: fixation
and verification) and Leeds (Accuracy in dose delivery).
The analysis of data concerning acute reactions seen in study 22991 on early prostate cancer, for
which a specific weekly questionnaire was designed by the RTT Section, was presented at the last
EGAM meeting 2009 and will be published shortly.
The RTT section has just initiated a new and ambitious project on the delineation of Organs at Risk,
with the ultimate goal of producing an atlas of guidelines. This will be a very useful but immense task!

                                                                                                            3. EORTC Current Research and Strategies
But we take up the challenge!

Collaboration with other groups (EORTC and others)

The ROG currently collaborates with the EORTC Brain Tumour, Head and Neck Cancer, Lymphoma,
Soft Tissue and Bone Sarcoma, Gastro-Intestinal Tract Cancer, Genito-Urinary Tract Cancer, Breast
Cancer and Lung Cancer groups; further collaboration is ongoing with the Radiation Therapy Oncology
Group (RTOG) and the North Central Cancer Treatment Group (NCCTG) in the US, the NCI-C
(Canada), the Scottish Cancer Trials Breast Group, the Borstkanker Onderzoeksgroep Nederland
(BOOG), the Intergroupe Francophone de Cancerologie Thoracique (IFCT), the Pan-European Trials
in Adjuvant Colon Cancer (PETACC), the French Fédération Nationale des Centres de Lutte contre
le Cancer (FNCLCC) and the Trans-Tasman Radiation Oncology Group (TROG) from Australia.
                                           Soft Tissue and Bone Sarcoma
                                           SoftTissue and Bone Sarcoma Group
                                           Structure of the Group

                                           Chair                                             P. Hohenberger, Mannheim (DE)
                                           Vice-Chair                                        J.-Y. Blay, Lyon (FR)
                                           Secretary                                         W.T.A van der Graaf, Nijmegen (NL)
                                           Treasurer                                         J.Verweij, Rotterdam (NL)


                                           Chair Pathology                                   A.P. Dei Tos, Treviso (IT)
                                           Chair Local Treatment                             A. Gronchi, Milano (IT)
                                           Chair Systemic Treatment                          P. Reichardt, Bad Saarow (DE)
                                           Chair Translational Research                      W. van der Graaf, Nijmegen (NL)
                                           Young Oncologists                                 M. Scurr, London (UK)
                                                                                             P. Rutkowski, Warsaw (PL)

                                           Membership and Principles

                                           As of December 2008, the Soft Tissue and Bone Sarcoma Group (STBSG) includes 47 full and 5
                                           probationary members from 12 countries. The group has a strict membership policy with regard
                                           to presence at group meetings, study accrual, and data quality. The pathological slides of all patients
                                           included in a clinical trial have to be reviewed centrally, and a level of 75% reviewed cases per trial and
                                           per centre is required. The pathology subcommittee allocates the review of histological slides and/or
                                           blocks according to expertise and regional distribution to its members. All claimed responses have to
                                           be confirmed independently if response is the primary endpoint of the trial. Sites are monitored by
                                           the EORTC Headquarters.
3. EORTC Current Research and Strategies


                                           Two meetings are held each year: when relevant, the spring meeting is linked to EGAM, whereas the
                                           2008 spring meeting was held in Marseille, April 3-4. The first day is dedicated to scientific questions,
                                           this time focussing on an interdisciplinary symposium on “Imaging in sarcoma: Hot topics of interest
                                           for multidisciplinary sarcoma studies” with radiologists and nuclear medicine physicians participating.
                                           The autumn meeting was held prior to CTOS (Connective Tissue Oncology Society) in London,
                                           November 13-16.
The four subcommittees meet to review their work, objectives, and projects which will be summarized
afterwards during the General Meeting which is open to all members as well as to outside parties,
such as collaborators from the pharmaceutical industry, and mainly discusses progress of ongoing
trials. Key members from other cooperative groups are invited to present the work of their group in
order to foster intergroup collaboration.


Clinical trials

The following studies were open for accrual within STBSG during 2008:
EORTC 62991/22998: a phase II study of radiotherapy in aggressive fibromatosis (40 patients
EORTC 62012: A phase III randomised trial of single agent doxorubicin versus doxorubicin plus            153
ifosfamide in the first line treatment of advanced or metastatic soft tissue sarcoma (225/265 expected
patients. randomized).
EORTC 62024: Localised, completely resected, gastrointestinal stromal tumours (GIST) expressing
KIT receptor: a controlled randomised trial on adjuvant Imatinib mesylate (Glivec) versus no further
therapy after complete surgery. (closed to entry at 908 patients in October 2008).
EORTC 62052: Phase II study of infusional E7389 in pre-treated patients with advanced and/or
metastatic soft tissue sarcomas (trial will be independently conducted in leiomyosarcoma, liposarcoma,
synovial sarcomas and other sarcoma subtypes and opens in 2006).
EORTC 62061: Randomized phase II trial of brostallicin versus doxorubicin as first line chemotherapy
in patients with advanced and/or metastatic soft tissue sarcomas (90 patients included).
EORTC 62981: EuroEwing: a phase III intergroup trial to evaluate the role of high dose chemotherapy
intensification in the treatment of intermediate prognosis’ Ewing sarcoma and PNET. Following closure

                                                                                                         3. EORTC Current Research and Strategies
of the R1 stratum and facing the necessity to implement a major amendment to this pan-European
trial which started prior to the EU Clinical Trials Directive, recruitment was stopped.

New studies to be opened in 2009

EORTC 62063: A phase III randomized study evaluating surgery of residual disease in patients with
metastatic gastro-intestinal stromal tumours responding to imatinib mesylate. Study coordinator:
A.Gronchi, Milano.
EORTC 62072: A randomized double blind phase III trial of Pazopanib versus placebo in patients
with soft tissue sarcoma whose disease has progressed during or following prior therapy (PALETTE).
Study coordinator: Winette van der Graaf, Nijmegen.
                                           EORTC 62082: A randomized trial of adjuvant trabectedin in intermediate and high grade soft tissue
                                           sarcoma with high ERCC1 and low BRCA1 expression. Study coordinator: Axel LeCesne, Paris.
                                           Imatinib mesylate (Gleevec®, Glivec®) in GIST: still a major involvement of the STBSG
                                           STBSG was instrumental in the development of imatinib in GIST and also was involved in the largest
                                           adjuvant trial worldwide.After publication of the American Z9001 study and the registration of imatinib
                                           for adjuvant therapy in the US, leading group experts were influential in the scientific community in
                                           Europe resulting in a more elaborated registration through EMEA.

                                           Studies on a unique retrospective data base

                                           The database of over 3000 patients treated with systemic chemotherapy for advanced STS (and more
                                           than 2000 patients treated in first line setting) continues to prove extremely valuable. The group
                                           funded a post-doctoral fellow (Monia Ouali, under the supervision of Martine van Glabbeke) who
                                           performed analyses of the database on topics approved by the board of STBSG:

154                                        •   DB-62-991 Lymphopenia as a prognostic factor for overall survival (J.Y.Blay);
                                           •DB-62-071 Adjuvant chemotherapy: pooled analysis of both STBSG studies (A.LeCesne, ASCO
                                           •DB-62-072 Prognostic factors in adolescents and young Adults (AYA) with high risk STS treated by
                                           adjuvant chemotherapy (B.Kasper, submitted to ASCO 2009).

                                           Translational Research

                                           The group initiated a fourth subcommittee responsible for initiating and fostering translational
                                           research efforts, and Winette van der Graaf functions as its coordinator. Translational research is not
                                           only conducted in the field of molecular characterisation of sarcomas and detection of prognostic
                                           and predictive signatures, but also integration of the recent developments in functional imaging is
                                           considered to be of major interest.
3. EORTC Current Research and Strategies

                                           The EORTC translational research grant 01/01 allowed the clinical and biological analyses of radiation
                                           induced sarcoma with the final analysis of molecular prognostic factors, and these results were
                                           presented orally during AACR 2009 (A molecular profile of radiation-induced sarcoma and its impact
                                           on treatment outcome).
                                           Translational research on the molecular analysis of GIST tumour samples of patients included in the
                                           EORTC 62005 trial led to several publications on the relevance of mutation analysis related to drug
                                           response and dosis, tissue microarrays, and pathology.
Projects for the following year

Clinical Research

Several phase II and III studies are scheduled for activation in 2009. The first discussion which is taking
place is related to the rapid success and accrual of the adjuvant EORTC 62024 imatinib study given
the low number of events at this stage. An IDMC will take place in 2009.
EORTC 62091: A phase IIb/III multicenter study comparing the efficacy of trabectedin administered as
a 3-hour or 24-hour infusion to doxorubicin in elderly patients with advanced or metastatic untreated
soft tissue sarcoma: Study coordinator: Binh Bui, Bordeaux.

Translational research

The EORTC 62043/62072 studies on pazopanib in STS will be accompanied by a programme of                       155
functional imaging to elucidate response characteristics.

Data base projects

New projects accepted by the Board:
•   DB-62-081: The relevance of doxorubicin dose intensity on response and outcome (S.Sleijfer).
•   DB-62-091 Effects of anthracycline-based chemotherapy in patients with locally advanced or
    metastatic angiosarcoma (R. Young, P.Woll).

Collaboration with other groups

                                                                                                              3. EORTC Current Research and Strategies
STBSG is developing a trial exploring the contribution of preoperative radiation therapy to DFS and
OS in retroperitoneal sarcoma in conjunction with the Radiation Oncology Group and mainly will use
the quality control measures established there.
ContiCaNet (Chair: Pr. J.Y Blay) and EuroBoNet (Chair: Pr. Pancras Hogendoorn, former chair of
the Pathology Subcommittee of STSBS) are EU-sponsored networks of excellence with several
groups members also working within these cooperations. The chairs are perfect links to anchor the
translational research studies of STBSG members to high level laboratories. The 2010 spring meeting
of the group will be held in conjunction with EuroBoNet in Leiden to foster collaboration between
both groups.
                                           STBSG is also committed to the development of intergroup studies with national sarcoma groups
                                           or in collaboration with large institutions and cooperative groups from the US. Recently the first
                                           transatlantic study was started, administration of IGFR1-antibodies in relapsed Ewing’s sarcoma
                                           (SARC-011), with several STBSG member institutions involved. Collaboration concerning research
                                           efforts is sought through the Connective Tissue Oncology Society.
                                           The group’s website has been developed at and is used for meeting
                                           announcements as well as for delivery of publication reports and minutes of the group meetings. The
                                           site provides links to the expert member institutions.
                                           In recognition of the contribution made by the STBSG to sarcoma research, the Group is well
                                           represented on the Connective Tissue Oncology Society (CTOS) Board. Members of the Board of
                                           directors include STBSG members Ian Judson (conference chair 2008), Alessandro Gronchi, Anders
                                           Krarup-Hansen, Patrick Schöffski, Paolo dei Tos and Jeremy Whelan.

3. EORTC Current Research and Strategies
Cancer in the Elderly Task Force

Chair                                            H. Wildiers, Leuven (BE)
Secretary                                        U. Wedding, Jena (DE)
Treasurer                                        A. Ring, Brighton (UK)
In addition, two young oncologists were nominated at the Meeting of the Cancer in the Elderly Task
Force (TFE):
B. Deschler, Freiburg (DE)
V. Girre, Paris (FR)
The TFE included 49 members.

Recent Achievements                                                                                          157

The TFE has had mainly an advisory function, but has been very active in the last 1-2 years developing
clinical trials in collaboration with the EORTC disease oriented groups. Three proposals have been
submitted to the Executive Committee meeting, one proposal is in a final stage of development.
A proposal has been made for a simple geriatric evaluation tool that can be used in all 70+ patients
who are entered in EORTC trials. The aims are to provide a common language across different groups
to evaluate elderly cancer patients included in EORTC trials and to establish age related prognostic
and predictive markers for overall survival, functionality changes, subjective wellbeing, social situation
changes, and toxicity.
Thanos Pallis, fellow of the TFE at EORTC Headquarters, performed an extensive search in the EORTC
database looking at the occurrence of toxicity in older versus younger individuals. The data were
presented at the EGAM meeting in Brussels, March 2009. Unfortunately, significant methodological
issues and missing data were present, not allowing strong conclusions on age dependent toxicities.

                                                                                                             3. EORTC Current Research and Strategies
Projects / Strategies for the following years

In collaboration with the EORTC disease oriented groups, the TFE has established the following
projects, which are at various degrees of development.
Protocol 75082-08086: Randomized phase II trial of abraxane vs. navelbine for patients aged 70 or older
with non small cell lung cancer. This is a collaboration between the TFE and the Lung Cancer Group.
The objective is to assess the activity of abraxane as opposed to that of navelbine, in chemonaive,
elderly NSCLC patients.
                                           Elderly patients with NSCLC stage IIIB/IV will be randomized between abraxane 125 mg/m2 weekly
                                           (wks 1-3, q4wks) and vinorelbine (30mg/m2 i.v. days 1 and 8 every 21 days or 80 mg/m2/week PO).
                                           Nr patients: 65 in abraxane arm; 33 in vinorelbine arm (2:1 sample size ratio). Rule to Phase III: 14
                                           responses or more in abraxane arm.
                                           CABEL Trial (Chemotherapy and Anti-angiogenic therapy in Breast cancer in the Elderly): A
                                           randomized phase II study of single agent capecitabine versus capecitabine- AMG-386 doublet, as
                                           first line treatment in elderly (≥70) breast cancer patients. Primary hypothesis is that AMG-386 in
                                           combination with capecitabine leads to a ≥65% Progression Free Survival rate at four months. The
                                           control arm (single agent capecitabine) is only intended for descriptive purposes. Patients will be
                                           randomized to experimental and control arms at a 2:1 ratio, respectively. 59 patients are required. The
                                           trial will be performed in collaboration with the EORTC Breast Cancer Group.
                                           Colorectal cancer: Treatment of KRAS wild type advanced Colorectal cancer patients with 5-FU vs.
                                           5-FU+ Cetuximab based on a comprehensive geriatric assessment. Phase III trial in advanced CRC.
                                           Inclusion criteria include age ≥ 80 or age ≥ 70 + with functional limitation (loss of 2/8 IADL or 1/10
                                           ADL) or increased morbidity score (Charlson morbidity score > 2). Primary endpoint is PFS and
                                           228 patients (136 wild type) are required. The trial will be performed together with the EORTC
158                                        Gastrointestinal Tract Cancer Group.
                                           In collaboration with the Brain Tumour Group, a proposal is under discussion for a specific chemo-
                                           radiation treatment regimen (without high dose Methotrexate) in older patients with central nervous
                                           system lymphoma.
                                           Geriatric Screening. Proposal for a simple geriatric evaluation tool that can be used in all age 70+
                                           patients who are entered in EORTC trials. One goal is to provide a common language across the
                                           various disease oriented groups to evaluate elderly cancer patients enrolled in EORTC trials. The
                                           instruments used should be simple and realistic for all participating centres. A second goal is to
                                           establish age related prognostic and predictive markers for overall survival, functionality changes,
                                           subjective well-being, social situation changes, and toxicity. The geriatric screening tool is based on the
                                           G8 (developed in France by Pierre Soubeyran).
                                           Quality of Life: Several members of the TFE participated in the design and are now recruiting patients
                                           at their home institutions for a trial being conducted by the Quality of Life Group, which is developing
3. EORTC Current Research and Strategies

                                           an elderly cancer patient specific quality of life questionnaire. “Protocol for developing a user-
                                           generated approach to health outcome measurement for older patients with cancer: pilot testing and
                                           validation of a questionnaire”. Sponsor: University of Southampton. Chief Investigator: C.D. Johnson,
Pan-European cooperation

The EORTC TFE is proposing a multidisciplinary workshop to be held at the end of 2009 at the
EORTC Headquarters with representatives of identified European networks to share ideas and
expertise on the optimal design and conduction of clinical trials in older patients. Which endpoints
are most relevant? Are there any specific methodological/ operational/ ethical issues to be considered
in the design of clinical trials in the elderly? What are the role and expectations for aging biomarkers?
In addition, standardization of data collection for elderly trials and optimal development and validation
of comprehensive geriatric assessments need to be considered.

Translational Research

Protocol 75082-08086: Randomized phase II trial of Abraxane vs. Navelbine for patients aged 70 or
older with non small cell lung cancer. A protein specifically secreted by the tumour (SPARC) binds and
entraps the albumin, allowing release of the hydrophobic drug to the tumour cell membrane. SPARC
levels appear to be highly associated with responses to Abraxane, and this will be tested prospectively.    159
Also caveolin will be assessed as a marker for chemosensitivity.

Collaboration with other groups

Within EORTC
The aim of the TFE is to develop elderly specific trials for those patients who are not candidates for
standard treatment. This aim will be achieved in collaboration with the EORTC disease-orientated
Collaborations with the Breast Cancer, Lung Cancer, Leukaemia, Gastrointestinal Tract Cancer, and
Brain Tumour Groups were established.
Collaboration with the Quality of Life Group continues in the validation of an elderly specific quality

                                                                                                            3. EORTC Current Research and Strategies
of life questionnaire.

Outside EORTC
For the above mentioned trial on metastatic colorectal carcinoma, a collaboration with the AIO
(Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society has been established.
For the geriatric assessment, close collaboration is ongoing with the French geriatric cancer units
who developed the G8 screening tool.
National groups (in which several TFE members are actively involved) will also be contacted for
support of clinical trials. For example, there are strong interactions with the French geriatric oncology
group, GERICO.
                                           Cutaneous Lymphoma Task Force

                                           Chair:                                          M. Bagot, Creteil (FR)
                                           Secretary                                       P.L. Ortiz-Romero, Madrid (ES)
                                           Treasurer                                       M. Vermeer, Leiden (NL)
                                           Translational Research:                         M. Vermeer, Leiden (NL)
                                           NDAC liaison:                                   R. Knobler, Vienna (AT)
                                           Young Oncologist:                               To be appointed

                                           Recent Achievements

                                           Ongoing trials

                                           Trial 21011: “A randomised, open-label phase III trial to evaluate the safety and efficacy of Targretin
                                           capsules combined with PUVA, compared to PUVA treatment alone in patients with stage IB-IIA
                                           cutaneous T-cell lymphoma (CTCL)”. The study was activated on October 2003. 89/145 patients have
                                           been included.
                                           Trial 21012: “Phase II clinical trial with Caelyx mono-chemotherapy in patients with advanced
                                           Mycosis Fungoides stage IIb, IVa and IVb with or without previous chemotherapy”. This trial was
                                           activated in February 2004. It is almost finished. 46/48 patients have been included.

                                           EORTC CLTF Meetings
3. EORTC Current Research and Strategies

                                           •   2008 Annual Clinical meeting: 5-7 September, Copenhagen, Denmark, R Gniadecki.
                                           •   Meeting at EGAM: 18 March 2009, Brussels, Belgium.

                                           Projects / Strategies for the coming years

                                           Clinical Trials

                                           An EORTC CLTF clinical trial platform has been discussed and built in order to improve the treatment
                                           of patients with advanced CTCL. This platform includes three successive trials.
EORTC 21081 Trial: “A phase III study of lenalidomide maintenance after debulking with gemcitabine
or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not
previously treated with polychemotherapy”. The trial should be activated in September 2009.
EORTC 21082 Trial: “Progression free survival comparison between suberoylanilide hydroxamic
acid (SAHA, Vorinostat), and the combination of SAHA and bortezomib (Velcade) in refractory
or recurrent advanced CTCL. A randomized study.” This protocol is not finalized and is still being
Trial in discussion with the European Bone Marrow Transplant Group. The aim of the trial is to
evaluate reduced intensity allo-stem cell transplantation in a series of patients with advanced
refractory CTCL.

Future Meetings

•   Annual Clinical meeting: 23-25 October 2008, Athens, Greece, L Papadavid.
•   October 2010 meeting: Barcelona, Spain.

Quality Assurance

All clinical trial activities within the task force are coordinated through and supported by the EORTC
Headquarters. Central reviews of all clinical and pathology data for the trials are ongoing.

Translational Research

Translational Research will be developed to complement the CLTF trial platform (microarray-based
transcriptome analysis and cytokine analysis). Evaluation of novel diagnostic markers in Sezary
syndrome: collaborative TR coordinated by M. Vermeer.

                                                                                                         3. EORTC Current Research and Strategies
Collaboration with other groups

EORTC: Radiotherapy group: a satellite session with the EORTC Radiation Oncology Group was
held during the Annual Clinical Meeting in Copenhagen September2008. This session was focused on
updating the EORTC CLTF guidelines for the use of Total Skin Electron Beam Radiation in cutaneous
T-cell lymphomas. Another session will be organized during the next Annual Clinical Meeting in
Athens in October 2009.
Non-EORTC: International Society for Cutaneous Lymphomas (ISCL). The task force is developing
appropriate endpoints and methods of disease assessment in conjunction with the International Society
for Cutaneous Lymphomas (ISCL) for use in trials of CTCL. European Bone Marrow Transplant Group
(EBMT) Development of the trial platform (see above)
3. EORTC Current Research and Strategies

4. Reports from the EORTC
Headquarters EORTCRegisteredOffice


                         EORTC Senior Management Team
                                (from left to right)
 Andrew Bottomley, Ann Marinus, Rémy von Frenckell, Jocelyne Flament, Richard Sylvester,
 Françoise Meunier, Denis Lacombe, Bernard Kamp, Martine Van Glabbeke, Pascal Ruyskart

                                                                                           4. Repor ts from the EORTC Headquar ters

                                           EORTC Headquarters, established in 1974, is a unique central facility within Europe that offers a
                                           comprehensive approach to clinical as well as translational cancer research and to the management
                                           of cancer clinical trials.
                                           EORTC Headquarters provides expertise over a broad range of activities and research areas
                                           including protocol and case report form development, national and international regulatory filings,
                                           data management, statistics, oncology, information technology, and other disciplines such as Quality
                                           of Life. EORTC Headquarters ensures, from an independent, objective and academic point of view,
                                           the performance of trials of the highest quality from design through final analysis to the publication
                                           of study results.
                                           In line with its aim to achieve optimal scientific results, EORTC Headquarters staff conduct research
                                           projects concerning methodology, and, through their participation as faculty at courses, workshops
                                           and congresses, or at events organised by EORTC Headquarters itself, many EORTC Headquarters
                                           staff members contribute to the education of healthcare professionals working in the field of cancer
164                                        research.
                                           The EORTC is the only European organisation that unites European cancer experts from all
                                           disciplines to establish transnational collaborations that facilitate, accelerate, conduct, and coordinate
                                           independent clinical and translational research on all types of cancer in Europe. The past four decades
                                           have proven beyond a doubt, that this form of collaboration is both successful and necessary in order
                                           to achieve important advances in the treatment of cancer and define new therapeutic strategies that
                                           are either more effective or less toxic.
                                           EORTC Headquarters is integral to the functioning of the EORTC, and it acts as a guardian with respect
                                           to the principles of independence and standards of quality for conducting clinical and translational
                                           cancer research.

                                           Progress Reports
4. Repor ts from the EORTC Headquar ters

                                           1. EORTC Headquarters Management of Clinical Trials

                                           EORTC Headquarters provides support for the management of all clinical trials for 19 EORTC clinical
                                           research groups. The following table lists the number of trials open to recruitment in 2008 and up
                                           to July 2009, the number of each type of trial by trial phase, and the number of patients recruited in
                                           each category.
                                                       January 2008 to July 2009
                                         Number of Trials                       Accrual Target
 Phase I                                          5                                  112
 Phase II                                        14                                 1,248
 Phase III                                       38                                 50,971
 Phase I/II                                       3                                  361
 Phase II/III                                     4                                 1,441
 Survey                                           -                                    -
 TOTAL                                           66                                 54,133

2. Scientific Output

In 2008 up to July 2009, the EORTC Headquarters staff members gave presentations at various
courses, symposia and conferences (ASCO, AACR, ESMO, AUA, and CTOS) and co-authored the
following numbers of publications:

 Peer-reviewed articles                                153
 Chapters in books                                      1
 Published abstracts                                   16
 Communications/ invited lectures                      25
 Miscellaneous                                         14
 Total                                                 209

3. Personnel

As of July 2009, the EORTC Headquarters staff consisted of 171 members (120 females, 51 males)
of which 138 are full-time and 33 part-time employees (representing 14 different nationalities) and

                                                                                                              4. Repor ts from the EORTC Headquar ters
include 8 research fellows, 7 interim staff and 3 consultants.

4. Statistics and Methodology

Applied statistical research continues in the following areas: novel designs for phase II and III trials,
interim analyses for phase III trials, non-proportional hazards, competing risks, cure rate models, frailty
models, prognostic factor analyses, assessment of predictive accuracy in survival models, survival
analysis of micro-array data, and the analysis of quality of life data. New procedures are evaluated
during Stats Club meetings to determine their relevance.
                                           As in previous years, work has continued in the field of meta-analyses. An individual patient data meta-
                                           analysis of the long term outcome with intravesical mitomycin C (MMC) versus bacillus Calmette-
                                           Guérin (BCG) for non muscle invasive bladder cancer was carried out by R. Sylvester (Eur Urol 2009,

                                           The EORTC Statistics Dept also participated in a number of meta-analysis research projects
                                           • a meta-analysis of the influence of resection margins and treatment for patients with pancreatic
                                           cancer (Arch Surgery, 2008);
                                           • a meta-analysis of chemotherapy in head and neck cancer (Radiother Oncol, 2009 ePub);
                                           • an update of the staging of lung cancer (IASLC) (J Thoracic Oncol, 2008);
                                           • a pooled analysis in rectal cancer to identify surgery related parameters affecting outcome (Eur J
                                           Cancer, 2009);
                                           • a combined analysis of the effect of irinotecan/flurouracil in the first line therapy of older and
                                           younger patients with metastatic colorectal cancer (J Clin Oncol, 2008);
                                           • an individual patient data based meta-analysis of the effect of preoperative chemo-radiotherapy in
                                           resectable oesophageal carcinoma (presented at ASTRO 2009);
                                           • characterization and outcome of acute lymphoblastic leukaemia patients with iAMP21 or Down
                                           syndrome (projects of the Ponte-di-Legno Group);
                                           • surrogacy for survival in taxane metastatic breast cancer trials (JCO, 2008);
                                           • post-operative adjuvant chemotherapy in gastric cancer and chemotherapy in advanced gastric
                                           cancer (GASTRIC meta-analysis group) (ASCO abstracts, 2008);
                                           • individual patient data meta-analysis of high dose chemotherapy for aggressive non-Hodgkin
                                           lymphoma (presentation EHA meeting, 2009);
                                           • the role of anthracyclines in the treatment of childhood acute lymphoblastic leukaemia through the
                                           Childhood Acute Lymphoblastic Leukaemia Collaborative Group (CALLCG) ( Br J Haematol,. 2009);
                                           • breast cancer through the Early Breast Cancer Trials Collaborative Group in Oxford (EBCTCG);
                                           • chemotherapy in non small cell lung cancer (NSCLC Collaborative Group) (J Clin Oncol, 2008);
4. Repor ts from the EORTC Headquar ters

                                           • an overview on the value of stem cell transplantation in acute myeloid and acute lymphoid leukaemia
                                           (Acute Leukaemia Stem Cell Transplantation Trialists’ Collaborative Group meeting, September
                                           • assessment of the beneficial and harmful effects of anthracyclines in the treatment of childhood
                                           acute lymphoblastic leukaemia (ALL): a systematic review and meta-analysis (BJC, 2009);
                                           • an overview of randomized trials in childhood ALL: questions regarding maintenance therapies;
                                           • cross-cultural analysis of the EORTC QLQ-C30 (Quality of Life Cross-Cultural Meta-Analysis
                                           Group, Qual Life Res, 2009);
                                           • meta-analysis of surrogate endpoints for overall survival in locally advanced Head and Neck cancer
                                           (Lancet Onc, 2009).
Research projects performed by members of the Statistics Department included the
Non muscle invasive bladder cancer. In addition to the MMC - BCG meta-analysis, prognostic factors
(EAU and AUA, 2008) and the effect of age (EAU, 2009) in patients treated with maintenance BCG
were studied. Together with former statistical staff now at Belgian universities, the methodology of
frailty models was extended to the validation of prognostic indices using data from 7 EORTC bladder
cancer trials (Lifetime data analysis, 2009).
Research continued on the use of prostrate specific antigen (PSA) to define surrogate endpoints in
prostate cancer trials (Eur Urol, 2008), the use of PSA kinetics to guide the timing of initiation of
androgen deprivation in patients with localized disease (Eur Urol, 2008), and on the use of marker
levels at 6 months for the selection of metastatic patients for more aggressive treatment interventions
(J Urol, 2008).
Staff contributed to the ESMO clinical recommendations for the diagnosis, treatment and follow-up
of patients with soft tissue sarcoma (Ann Oncol, 2008) and to the ESMO clinical recommendations
for the diagnosis, treatment and follow-up of patients with gastro intestinal stromal tumours (GIST)
(Ann Oncol, 2008). A meta-analysis of trials assessing the role of STI-571 in unresectable or metastatic    167
GIST expressing the KIT receptor tyrosine kinase were performed, and a paper has been submitted
for publication.
Research continued in melanoma and leukaemia in the following areas:
• Prognostic and predictive importance of ulceration in stage IIb – III primary melanoma patients on
the efficacy of adjuvant interferon treatment versus observation (ASCO 2009);
• Lack of prognostic importance of autoimmune antibodies in EORTC adjuvant Interferon melanoma
trial 18952 and the Nordic IFN Melanoma trial (ECCO 2008, JNCI (in press)) together with S. Collette
and in the EORTC adjuvant PEG-Interferon melanoma trial 18991;
• Prognostic importance of serial assessment of S100B in stage IIb – Stage III melanoma patients
included in EORTC trial 18952;
• Assessment of LDH correlation with survival in advanced melanoma from two large randomised
trials (Oblimersen GM301 and EORTC 18951) (EJC, 2009);

                                                                                                            4. Repor ts from the EORTC Headquar ters
• Prognostic importance of CNS involvement in childhood ALL in study 58951 (ASH, 2008);
• The evaluation of the incidence of second neoplasms subsequent to therapy for childhood ALL or
lymphoblastic lymphoma (manuscript in preparation).
Staff contributed to the first update of RECIST (Response Evaluation Criteria in Solid Tumours,
originally published in 2000) which resulted in 3 papers in the EJC in 2009. A large database of detailed
tumour measurement information was brought together and analyzed at the EORTC Headquarters
(16 Phase III trials, over 10,000 patients) to allow the assessment of the new criteria. Version 1.1 of
RECIST was published in a special edition of the European Journal of Cancer (vol. 45) in January 2009,
and preparations are ongoing for the next update.
                                           An assessment of the prognostic value of baseline factors in newly diagnosed glioblastoma patients to
                                           predict survival was published. Nomograms with and without the MGMT promoter methylation status
                                           were developed (Lancet Oncology, 2008). A PhD thesis (T. Gorlia) on the diagnosis and prognosis of
                                           brain tumours has already resulted in several publications: nomograms for predicting the survival of
                                           patients with newly diagnosed glioblastoma (Gorlia et al. Lancet 2008) and assessment of the value
                                           of molecular characteristics to supplement the prognostic information provided by histo-pathological
                                           information for anaplastic oligodendroglial tumours (Neuro Oncol 2009, ePub).
                                           Methodological research on reporting of quality of life data together with other members of the Quality
                                           of Life Department continues (Eur J Cancer Care 2009, J Clin Oncol 2009) as do collaborations with
                                           the Quality of Life Department in a project and the University of Liège on methods for the analysis of
                                           ordinal longitudinal QoL data. In addition, staff investigated the analysis of QoL data in the setting of
                                           very poor prognosis patients where the drop out rate is very high, i.e., patients with brain metastases
                                           from another cancer (JCO, 2008), and participated in guidelines on the publication of these results
                                           (Lancet Oncol, 2008) in collaboration with the University of Liège.
                                           The value of the disease control rates at 9 and 18 weeks were investigated to predict overall survival
                                           in patients with malignant pleural mesothelioma using data from 10 EORTC Lung Cancer Group
168                                        studies, and publications are in preparation. Work also continues on in an internal project for the
                                           development and validation of nomograms in the setting of competing risk time to event data.
                                           A nomogram was developed for the prediction of the long term risk of breast fibrosis in early breast
                                           cancer treated by breast conserving therapy with or without a boost dose of irradiation (Eur J Cancer
                                           2008). The prognostic importance of changes of Ferritin and CRP levels in melanoma patients treated
                                           with adjuvant interferon α were also investigated in the EORTC 18952 trial (ECCO 2009) as well as
                                           the prognostic importance of serial assessments of circulating melanoma cells in stage III melanoma
                                           patients included in EORTC 18991 trial (Clinical Cancer Research, in press).
                                           The EORTC minimization procedure was updated to incorporate a random allocation component
                                           to address regulatory concerns. The standard statistical analysis programs (SAS macros) underwent
                                           a formal procedure of testing and validation. The EORTC Statistics Department Standard Operating
                                           Procedures were updated, and improved quality control on programming, reporting and documentation
                                           was implemented.
4. Repor ts from the EORTC Headquar ters

                                           5. Information Technology (IT) Department

                                           The IT Department is responsible for the development of software and systems used to manage
                                           cancer clinical trials. ORTA (On-line Access to Randomized Trials) is the patient registration and
                                           randomization system. VISTA (Visual Information System for Trial Analysis) is the Clinical Trial
                                           Management System. Web interfaces to these tools provide services to the EORTC centres.
                                           • The VISTA Remote Data Capture application has been enhanced with an electronic query management
                                           system providing an easy way for the clinicians to resolve data discrepancies.
                                           • The online central image review system installed for specific protocols has now been running for
                                           about one year. Based on this successful experience, the foundations for the new EORTC Imaging
                                           infrastructure are being laid down.
Information Technology systems at the EORTC Headquarters
The configuration of the EORTC computer system is based on client/server technology mainly
powered by Windows and Red Hat Linux servers.
There are several servers, each dedicated to a certain category of service:
• Windows 2003 servers provide the file services and print services;
• The SQL Server handles the clinical database management system (VISTA);
• An Exchange server is used for internal/external mail and office collaboration tools;
• The Linux servers handle the Internet connection, and the email traffic filtering;
• Dedicated appliances are used for network protection (firewall) and virtual private network access
• PCs running Windows XP have access to all the local resources and to the Internet.
VISTA is the Clinical Database Management and Reporting System used at EORTC Headquarters.             169
It assists the complete clinical trial process, from form design to reporting of results. For more
complex statistics, all PCs have access to the SAS system for Windows. VISTA was developed in-house
to respond to the specific daily work needs of EORTC Headquarters. It takes full advantage of the
Windows environment and provides the users with an easy-to-use interface. VISTA is a client/server-
based system powered by an SQL server relational database.
The ORTA system is used for patient registration. It allows complex eligibility checks and dynamic
treatment allocation. Registered patients are automatically transferred into the VISTA system. ORTA
is a web-based application available from any browser on the internet.
A Remote Data Capture module (VISTA RDC) is integrated into the system. It is a web based system
that allows investigators to send their data in electronic format.
The software developed at EORTC Headquarters follows a standard System Development Life Cycle
(SDLC) in order to comply with the regulations of the US FDA (United States Food and Drug
Administration), 21-CFR part 11 (electronic records – electronic signature).

                                                                                                       4. Repor ts from the EORTC Headquar ters
6. Quality Assurance for Radiotherapy (QART)

QART at the EORTC builds on the 27 years’ experience of the EORTC Radiation Oncology Group in
pioneering QART in the clinical trial setting in Europe and internationally. The QART team develops,
administers and analyses Quality Assurance procedures with the aim of ensuring the quality of
radiotherapy within the broad spectrum of EORTC trials.
2008 saw the appointment of a full-time QART manager, recognizing the increasing importance of
QART to the quality of EORTC trials. The Emmanuel van der Schueren Fellow, supported by the
Vlaamse Liga tegen Kanker, remains an integral part of the QART team responsible for specific QART-
related research projects and QART scientific output.
                                           Specific projects in 2008 and 2009 have included the development of consensus guidelines for target
                                           delineation in cancer subtypes and the application of Normal Tissue Complication Probability (NTCP)
                                           modelling techniques to past and future EORTC trials.
                                           In 2008 the Radiation Oncology Group and QART team embarked on an international collaborative
                                           effort with US groups and the International Atomic Energy Agency with the aim of the harmonization
                                           of QART procedures worldwide. A prospective assessment of External Reference Dosimetry Audit
                                           in specific international clinical trials will commence in 2009.
                                           In recent years the EORTC QART team has successfully implemented the digital collection of
                                           full radiotherapy treatment information. In view of this in 2009 the EORTC invested in VODCA
                                           (Visualisation Of Data for Cancer Analysis), a software package designed specifically for the
                                           administration, organization and analysis of radiotherapy digital data in the setting of multicentre
                                           clinical trials. The facility to review, analyse and store complete digital treatment data will be integral
                                           to the future development of QART at the EORTC.
                                           The QART team is currently overseeing 12 ongoing and 6 forthcoming trials involving radiotherapy, and
                                           remains committed to developing new strategies to address the challenges of advanced radiotherapy
170                                        techniques in the knowledge that high quality radiotherapy within clinical trials has a beneficial effect
                                           for all patients receiving radiotherapy.

                                           7. Quality of Life (QOL) Department

                                           The QOL Department is responsible for developing and analysing the quality of life component of
                                           EORTC clinical trials and acts as a support unit for research undertaken by the EORTC QOL Group.
                                           The QOL Department also conducts its own specific research projects.
                                           Since the beginning of 2008, the QOL Department has worked on the research project, PROBE,
                                           funded by the Pfizer Foundation, as part of its Global Health Partnership Program. The aim is to
                                           explore quality of life (QOL) and psychosocial issues in cancer patients. So far, results from this three-
                                           year project have been reported in 12 abstracts, one invited conference, and four peer reviewed
4. Repor ts from the EORTC Headquar ters

                                           The QOL Department continues to actively collaborate with the Quality of Life Group (QLG) and by
                                           the end of 2008 had developed the EORTC QLG module for bone metastases funded by the Canadian
                                           Institute of Health Services Research Grant. In early 2009, the EORTC QLG grant to validate the
                                           brain cancer module via analysis of data held in the QOL Department was completed (publication in
                                           press). After a four-year field study managed from within the Department and with collaboration with
                                           the QLG, the prostate module is now validated and published.
                                           Recently completed is a research project funded by AstraZeneca to evaluate the FDA and EMEA QOL
                                           guidance on future clinical trial design, and results of this project were published in the European
                                           Journal of Cancer in April 2009. A joint EORTC external research project with the University of Liege
                                           is currently ongoing, and it focuses on the longitudinal analysis of QOL data as ordinal data (and on
                                           the complex issue of missing data). This analysis will be completed by the end of 2009.
In addition to PROBE, mentioned above, the QOL Department has successfully presented for
publication 25 peer-reviewed abstracts following their presentation (oral and poster) at international
scientific meetings including ASCO and ISOQOL. A total of 15 peer-reviewed articles were published
in journals, including the Journal of Clinical Oncology and The Lancet Oncology, as were three book
chapters on QOL research methodology. A further six peer-reviewed papers on topics such as QOL
in relation to symptoms clusters, clinical significance of QOL results, and QOL policy are in press.
Eight additional papers submitted are under revision or in preparation.
The QOL Department collaborated actively with the EORTC disease oriented Groups during 2008/9,
as its remit is to fully support EORTC clinical groups in implementing clinical trials. QOL studies were
activated in 12 new clinical trials, and over eight clinical trials with QOL data were published for
disease oriented groups such as the Lung Cancer, Brain Tumour, Radiation Oncology, Melanoma and
Head and Neck Cancer groups. Successful collaboration on clinical trials with the Genito-Urinary Tract
Cancer group is recognised for the trial on QOL and symptoms for locally advanced prostate cancer.
This was awarded the best presentation at the 2009 European Association of Urology Congress.
The Department continues to meet a constantly rising number of worldwide requests for EORTC
QOL measures. The commercial use of EORTC QLG tools increased in 2008, with 46 different
organisations from 15 countries contracting to use QOL questionnaires. During the period 2008-9,           171
EORTC QLG core and disease-specific questionnaires were translated into over 60 languages. The
total number of validated translations now exceeds 640, and more than 230 additional translations are
in progress or being pilot tested. Much time and effort is devoted to checking translations, harmonizing
response scales and items, and achieving consistency across translations and cultural adaptations. A
pilot study focusing on response scale harmonization in Spanish was submitted as an abstract for the
2009 16th ISOQOL meeting.
In early 2009, the EORTC Translation Manual was updated to keep pace with new technology such
as a translation memory tool and a Translation Quality Assessment (TQA) that was implemented in
2008. Both tools aim at improving quality.
This TQA was presented at the 15th ISOQOL Annual Meeting in Montevideo, Uruguay, 2008. The
new procedures also include a standard archiving, certification and documentation process compliant
with GCP practice. In 2009, the Department completed a joint two-year project with the QLG and
updated the EORTC QLG Item Bank. This now contains all recently validated questionnaire versions,

                                                                                                           4. Repor ts from the EORTC Headquar ters
completed phase III modules, and translations. The Item Bank is online and hosted on the EORTC web
server. It provides instrument developers in the EORTC with the opportunity to use existing items,
have a good standardization of translations, and to speed up the instrument development process.
In collaboration with the QLG, the EORTC Reference Values Manual containing reference data for
over 40,000 patients was updated and published in 2008 and is available online. Also in 2008 the
EORTC QOL web site was revised with a modern look and easier access for users. During 2008 and
the first half of 2009, the EORTC QOL Department received and responded to more than 3,500
requests to use EORTC QOL measures.
                                           During this period, the QOL Department staff undertook several education initiatives and invited
                                           presentations. Invited presentations were made by Corneel Coens, Chantal Quinten, and Dr Andrew
                                           Bottomley. Furthermore, Chantal Quinten won the MASCC Young Investigator Award for the 2009
                                           annual conference. Department staff also taught in numerous national and international oncology
                                           courses and advised various groups such as the US National Cancer Institute and the European
                                           Commission on QOL research practice and policy.
                                           To investigate a range of topics in QOL, including clinical significance of QOL data from trials, the
                                           analysis methods used for QOL, exploration of time windows, symptom clustering, the psychosocial
                                           impact of QOL on patients, and various meta-analysis, several research follows were recruited. Fellows
                                           were invited to the MD Anderson Cancer Centre in Houston, Texas, for scientific visits and to share
                                           knowledge and experience in both symptom clustering and methodological investigation into QOL
                                           In 2008 Andrew Bottomley became Editor of the Expert Review of Pharmacoeconomics and
                                           Outcomes Research Journal, and staff in the Department regularly undertook peer reviews for major
                                           journals, conferences, and grant donating bodies.These included such journals as the Journal of Clinical
                                           Oncology and The Lancet.
                                           Looking to the future, proposals for five new retrospective clinical trials with QOL are under
                                           discussion, a number of additional papers are in preparation, and the Department is organising a major
                                           EORTC conference on QOL, symptom research, and patient reported outcomes in cancer clinical
                                           trials to be held in Brussels in November, 2009.

                                           8. Regulatory Affairs and Intergroup Unit (RAIU)

                                           The Regulatory Affairs Unit and the Intergroup Office have been merged to form the RAIU.
                                           The RAIU is responsible for the submission of new EORTC clinical studies and major protocol
                                           amendments to the appropriate regulatory authority and ethics committees. This unit also cooperates
                                           on specific projects with the pharmaceutical industry when required. The RAIU is continuously
                                           updating its procedures to ensure compliance with the legal provisions governed by the European
                                           Clinical Trial Directive 2001/20/EC and its various national implementations.
4. Repor ts from the EORTC Headquar ters

                                           With the increased emergence of translational research projects, the RAIU is investigating existing
                                           legislation related to biobanking and to the use of human tissues and cells for research purposes.
                                           The RAIU facilitates the setting up of intergroup trials between the EORTC and other groups. It
                                           ensures that appropriate agreements are established between groups and controls the development
                                           of group specific appendices within clinical trial protocols.

                                           Intergroup Trials and Activities
                                           Five new intergroup trials were opened during the course of 2008. The EORTC was the
                                           coordinating group for 2 trials and participated in 3 trials coordinated by other groups.
The NCI-NCRI-EORTC working group, established to facilitate intercontinental collaboration, has
progressed in terms of facilitating this particular type of collaboration by issuing a number of guidelines
and position papers.
The Liaison Office in France has been transferred to the Fédération Nationale des Centres de Lutte
Contre le Cancer, and the UK Liaison Office welcomed a new liaison officer. EORTC continues to
explore the possibility of having liaison offices in other countries.

9. Quality Systems & Compliance Unit (QS&C)

The QS&C promotes and encourages quality awareness throughout the organisation and provides
expertise in the definition, creation and writing of documents pertaining to clinical activities. This
team contributes to minimizing the risk of non-compliance, coordinates internal and external audit
programs, and provides the necessary training and assistance to achieve these goals.
The QS&C participated in the organization of 44 training courses related to Standard Operating
Procedures, Work Instructions, Computer System Validation, GCP and the implementation of new
legislation in Europe including feedback from regulatory authorities’ inspections.                            173
In 2008, the EORTC was subject to 4 external audits by the pharmaceutical industry, 2 internal audits
involving 2 disease/treatment-oriented groups. The QS&C performed 23 external audits as foreseen
by the EORTC audit program concerning 10 different trials in 8 separate EORTC Groups.
Three clinical investigator sites were inspected on their collaboration to EORTC studies. Inspections
were performed by regulatory authorities in view of regular GCP inspection programme or submission
of marketing authorization.
In 2008, the Data Timeliness Procedure was applied on 2 occasions (April and October). A limited
number of centres were temporarily closed as a result of persistently missing information and non-
compliance issues.

10. Translational Research Unit (TRU)

                                                                                                              4. Repor ts from the EORTC Headquar ters
The TRU actively participates in developing translational research proposals at several stages
in protocol development, thereby acting as an EORTC Translational Research quality assurance
mechanism (e.g. 57 outlines underwent Translational Research Committee [TRAC] review in 2007-
2008). The TRU/TRAC review process covers both scientific and technical aspects of translational
research projects integrated into EORTC clinical trials. Initially, the TRU and EPOD work closely to
align translational research studies in project outlines with EORTC strategy to optimize translational
research project development at an early stage. The TRU also supports the activities of TRAC in the
review of translational research projects during protocol development and the TRU performs a final
check on all EORTC fully developed clinical protocols.
TRU/TRAC has continued to monitor the progress of all ongoing EORTC translational research fund
supported projects through the timely review of interim and final scientific reports, as well as all
corresponding scientific publications (19 peer reviewed articles in total).
                                           The TRU has been actively involved in strategic developments of the EORTC Translational Research
                                           network while continuing its regular PRC-linked Quality Assurance function and logistical aid for a
                                           number of ongoing translational research projects.

                                           A fundamental part of the TRU activities are devoted to the development of an EORTC bio-banking
                                           strategy which aims to progressively develop EORTC bio-resources and to assist EORTC investigators
                                           with their translational research and pathology review programmes.
                                           EORTC is a full partner to an FP6 EU CHEMORES project (chemo-resistance in melanoma and lung
                                           cancer) initiated in 2006. The TRU is involved in the bio-banking of CHEMORES tissue as well as
                                           Virtual Microscopy activities for a number of EORTC Melanoma Group trials.
                                           In 2008, the tumour bank implemented and focused on further practical developments of the
                                           “Prospective Tissue and Biofluids Collection” initiative (PTC).This programme aims at the construction
                                           of a qualitative, independent biorepository under EORTC custodianship for pivotal clinical trials.
174                                        In collaboration with several EORTC Pathobiology Group members, service providers have been
                                           audited and selected for: secured sample storage, processing (mainly focused on Tissue Micro-Array
                                           construction and molecular biology services), shipment, collection kit distribution and IT systems
                                           supporting sample logistics.
                                           In order to test the operation the PTC by the EORTC Headquarters, pilot projects have been selected:
                                           EORTC 22043-30041 (prostatic carcinoma trail), EORTC 22071-24071 (head and neck squamous cell
                                           carcinoma), EORTC 62063 (advanced GIST) that will serve as models to develop standard operating
                                           procedures (SOPs), the ethical and legal framework and logistical details (patient recruitment begins
                                           in 2009).
                                           The EORTC is a partner of the FP6 funded CHEMORES consortium providing scientific, legal, logistic
                                           and administrative support related to the involvement of a series of large EORTC melanoma clinical
                                           trials into the project.
                                           The TRU contribution concerns the collection of clinical data and patient samples from retrospective
                                           (EORTC 18952 & 18991) and prospective (EORTC 18032) clinical trials in Melanoma to participate
4. Repor ts from the EORTC Headquar ters

                                           to the constitution of a Biological Resource Centre (BRC) for identification and further validation of
                                           key mechanisms and pathways of molecular resistance and toxicity to chemotherapy. Since the end
                                           of 2007, a web-based Virtual Tissue Bank (VTB) has been implemented at the EORTC HQ with the
                                           financial support of CHEMORES in order to actively support the development of the Melanoma BRC
                                           sharing sample locator web based tool, image analysis and virtual slide facilities. The VTB system will
                                           enable a proper documentation of the collected biomaterials with associated data and facilitate the
                                           consequent work of analysis and validations.
                                           The TRU in collaboration with the EORTC IT department continues upgrading the VTB system.
                                           The current platform now incorporates one virtual microscope, three server machines to host the
                                           different applications and network attached storage devices to serve digital images and data in a
                                           secured way. The upgraded VTB system has been used for pathology review programmes as well as
                                           translational research programmes the following activities:
Translational research support in PETACC-2 trial (EORTC 40963) by a full integration of a clinical
dataset (700 patients) with the inventory of the biological material used in this program, as well
as digitized images of Tissue Micro-Arrays and full section slides. Currently, TRU is also integrating
translational research data coming from 5 different translational research projects, based on the
collected biological material (genotype and immunohistochemistry data)
Central pathology review support for a bladder carcinoma in situ trial (EORTC 30993) has been
finalized in 2008. Material handling (formalin fixed, paraffin embedded tissue blocks and section) was
managed by the TRU. The support also included telepathology, enabling the central review pathologists
to review the digital images of these tissue sections.
Central pathology review support for the EORTC 26951 trial (highly anaplastic oligodendrogliomas).
Virtual slides for approximately 350 patients have been prepared and will be made available through
secured EORTC servers during 2009 with associated forms to support the work of the panel of
The TRU has further pursued the development of the Virtual Tumour Bank (VTB) website as a central
focal point to bio-banking activities and provided support to the EORTC HQ teams in organizing
sample collections on a regular basis (e.g. SOPs, sample logistics budgets, review of incoming collection   175
projects). Furthermore the TRU has actively contributed to the development and dissemination
of best standards for international bio-banking in collaboration with experts from the EORTC
PathoBiology Group such as the “Common Minimal Technical Standards and Protocols for Biological
Resource Centres dedicated to Cancer Research” which is summarized by IARC (

11. EORTC Fellowship in 2008-2009

Seven medical fellows worked on their programs at the EORTC Headquarters in the following fields:
quality assurance in radiotherapy (granted by the Vlaamse Liga tegen Kanker / Emmanuel van der
Schueren Fellowship) and general methodology of cancer clinical trials (breast, gynaecological, lung
and elderly cancers).
Four statisticians (from France, Italy and Zimbabwe) came also to the EORTC Headquarters to

                                                                                                            4. Repor ts from the EORTC Headquar ters
specialize in the field of cancer clinical trials statistics (soft tissue and bone sarcomas) and to work
within the EORTC Quality of Life Department on a research project PROBE (Patient Reported
Outcomes and Behavioural Evidence).
Two health scientists (from The Netherlands and Hungary) worked on research projects on quality
of life in cancer patients.
One lawyer from Belgium made a research analysis of the various national regulatory frameworks
governing clinical research in Europe (implementation of the 2001 Directive) as well as legal, ethical
and regulatory aspects of biobanking (research on human tissues and cells).
Support for this Fellowship Program was obtained from several sources including the Vlaamse
Liga tegen Kanker, the Vivian Percy Grant, EORTC Breast Cancer Group, TRANSBIG, EORTC Soft
Tissue and Bone Sarcomas Group, the Pfizer Foundation, the King Baudouin Foundation, and EORTC
Headquarters. This funding program is coordinated by the EORTC Charitable Trust.
                                           The Fonds Cancer / FOCA (Belgium) also contributed to the support of EORTC Fellowship

                                           12. Education Office

                                           The EORTC Education Office provides logistics support for the organization of EORTC courses
                                           (on the methodology of clinical trials, statistics, data management, quality of life and other topics)
                                           as well as for EORTC conferences including EGAM (EORTC Groups Annual Meeting), and ENASCO
                                           (EORTC-NCI-ASCO Meeting on Molecular Markers in Cancer).

                                                         For further information, please contact:
                                                                              Education Office Coordinator

                                           Continuing Education at the Headquarters

176                                        The EORTC continued its collaboration with Belgian Universities in organizing the third year of the
                                           Postgraduate Medical Oncology Course at the EORTC facilities. EORTC Headquarters staff had the
                                           opportunity to attend the courses.
                                           Further to the central coordination of training at the Headquarters, a procedure was put in place to
                                           harmonize trainings and their documentation within the various units and departments.
                                           In 2008, 336 sessions were given covering various topics such as oncology, data management, statistics,
                                           good clinical practice, information technologies, and internal procedures.

                                           13. Communications Office

                                           The Communication Office aims to increase the visibility of EORTC research activities and raise
                                           public and media awareness of the importance of cancer clinical research in Europe. In light of these
                                           aims, in March 2009 the Communications Office launched the EORTC Newsletter.
4. Repor ts from the EORTC Headquar ters

                                           The EORTC Communications Office provides information on an ongoing basis to the various European
                                           cancer leagues, the scientific community, patients, and the public.

                                                                            For further assistance, please contact:
                                                                                   Medical Science Writer
5. Courses and Conferences 2007
In 2008-2010, the EORTC Headquarters staff members were/are involved in the organization and
teaching of the following courses and meetings:

EORTC Courses in 2008

• Clinical Trial Statistics for Non Statisticians (Brussels, Belgium, 10-13 June)
This course was designed as an introduction to the statistical principles which form the basis for
the design and analysis of cancer clinical trials. It focused on the philosophy and understanding
of the statistical principles that are used on a day-to-day basis in conducting clinical trials and
did not simply present statistical formulae in a cookbook fashion. This course was aimed at
non-statisticians (medical doctors, data managers, etc.) who were already working in the field of
clinical trials and who have had an introductory course in statistics or at statisticians with little or no
experience in clinical trials. For those persons who wanted a review of the basic statistical concepts,       177
an optional half day introduction to statistical methods was organized.
• One-Day Introduction to EORTC Trials (Brussels, Belgium, 3 October)
This course was dedicated to newly participating members (investigators, data managers, research
nurses, etc.), and industry representatives. The purpose of this introductory workshop was to give
guidance for participating in EORTC clinical trials activities. Participants received information about
the functioning of the EORTC and about Trials methodology, investigator / site quality requirements
and control, patient safety management, adequate data collection and pitfalls for reliable data.
Furthermore, participants were shown our on-line registration /randomization process and remote
data capture system. It also provided an opportunity to visit the EORTC Headquarters and to have
informal discussions with the Headquarters staff.

EORTC Meeting in 2008

• EORTC Strategy Meeting (La Hulpe, Belgium, 13-14 March 2008)
This strategic meeting was aimed at advancing the EORTC scientific strategy and fostering interaction
between the Board and the groups on the groups’ strategies and on the EORTC translational research
agenda including biobanking and NOCI.
                                                                                                              5. Courses & Conferences

EORTC Courses in 2009

• Clinical Trial Statistics for Non Statisticians (Brussels, Belgium, 9-12 June)
• One-Day Introduction to EORTC Trials (Brussels, Belgium, 11 September)
                                 EORTC Meetings in 2009

                                 • EORTC Groups Annual Meeting, EGAM (Brussels, Belgium, 7-10 March)
                                 • EORTC-NCI-ASCO Annual Meeting on Molecular Markers in Cancer (Brussels, Belgium, 15-17
                                 October), with a tutorial on 14 October and 15 October (morning)

                                 EORTC Courses in 2010

                                 • Clinical Trial Statistics for Non Statisticians (Brussels, Belgium, Spring)
                                 • One-Day Introduction to EORTC Trials (Brussels, Belgium, Fall)

                                 EORTC Meeting in 2010
178                              • EORTC Strategy Meeting (Brussels, Belgium, 18-19 March)

                                                      For further assistance, please visit the Education Office website:
                                                                or contact:
                                                                  EORTC Education Office Coordinator
5. EORTC Courses & Conferences
6. EORTC Directory


             Françoise Meunier, EORTC Director General
               Denis Lacombe, Scientific Director (right)
      Rémy von Frenckell, Director of Methology & Operations (left)
                                                                      6. EORTC Director y
                                  EORTC Staff Directory
                                  Avenue E. Mounier, 83, b 11
                                  1200 Brussels, Belgium
                                  Phone: +32 2 774 16 11

                                  FAX NUMBERS
                                  General:                              +32 2 772 35 45
                                  Headquarters:                         +32 2 771 38 10
                                  Director General:                     +32 2 771 20 04
                                  Scientific Director:                  +32 2 772 61 97
                                  Director Methodology & Operations     +32 2 772 35 45
                                  Education & Communications Offices:   +32 2 772 62 33
                                  Pharmacovigilance Unit:               +32 2 772 80 27
                                  Quality of Life Unit:                 +32 2 779 45 68
                                  PRC Secretariat:                      +32 2 772 46 21
180                               Leukaemia Unit:                       +32 2 772 70 63

                                    Name                                  Telephone       E-Mail
                                    Aerts Claire                        +32 2 7741640
                                    Akrapovic Anita                     +32 2 7741088
                                    Allgeier Anouk                      +32 2 7741047
                                    Ashimwe Wilson                      +32 2 7741042
                                    Baila Liliana                       +32 2 7741663
                                    Bastiaens Edith                     +32 2 7741081
                                    Bastin Christine                    +32 2 7741065
                                    Baus Katrien                        +32 2 7741053
                                    Bean John                           +32 2 7741671
                                    Bekka Nawal                         +32 2 7741604
                                    Bellem Christophe                   +32 2 7741077
                                    Blieck Nejma                        +32 2 7741667
                                    Bogaerts Jan                        +32 2 7741063
6. EORTC Director y Conferences

                                    Bottomley Andrew                    +32 2 7741661
                                    Breyssens Hilde                     +32 2 7741004
                                    Calatayud Eva                       +32 2 7741012
         Courses &

                                    Cazeils Sandrine                    +32 2 7741095
                                    Celis Miet                          +32 2 7741061
                                    Cnockaert Delphine                  +32 2 7741060
                                    Coens Corneel                       +32 2 7741632
                                    Collette Laurence                   +32 2 7741669
Collette Sandra           +32 2 7741046
Cornelissen Ken           +32 2 7741678
Couvreur Marie-Laure      +32 2 7741067
Crokart Nathalie          +32 2 7741066
Czimbalmos Agnes          +32 2 7741665
Dal Lago Lissandra        +32 2 7741008
Daubie Valery             +32 2 7741040
de Balincourt Christine   +32 2 7741684
De Brauwer Annick         +32 2 7741043
De Burghgraeve Peter      +32 2 7741031
De Prijck Linda           +32 2 7741610
De Rouck Maarten          +32 2 7741660
De Schaetzen Gaetan       +32 2 7741618
De Vos Monika             +32 2 7741021
De Vrye Gilles            +32 2 7741629             181
De Wever Joke             +32 2 7741624
Debruyne Ilka             +32 2 7741002
Decossaux Eric            +32 2 7741666
Decot Sabrina             +32 2 7741095
Deleu Steven              +32 2 7741036
Demeester An              +32 2 7741015
Derbal Farha              +32 2 7741611
Devleeschouwer Francine   +32 2 7741694
Dewaste Valérie           +32 2 7741656
Dewolf Linda              +32 2 7741680
Dictus Marlies            +32 2 7741677
Dohogne Yves              +32 2 7741621
Douterlungne Steve        +32 2 7741623
Druyts Dorien             +32 2 7741695
Dubois Nathalie           +32 2 7741676
                                                                             5. EORTC Courses y Conferences

Duez Nicole               +32 2 7741022
Elmedassi Nadia           +32 2 7741044
Engelen Kristel           +32 2 7741082
Fenton Paul               +32 2 7741007
                                                                                      Director &

Flament Jocelyne          +32 2 7741049
Fortpied Catherine        +32 2 7741681
Fortun Axelle             +32 2 7741089
Gauthier Marie-Pierre     +32 2 7741014
Geithman Angela           +32 2 7741698
                                  Geyoro Lily              +32 2 7741641
                                  Ghislain Irina           +32 2 7741057
                                  Gilotay Caroline         +32 2 7741659
                                  Giurgea Livia            +32 2 7741692
                                  Gobbens Laura            +32 2 7741670
                                  Gonay Nelly              +32 2 7741664
                                  Gorlia Thierry           +32 2 7741652
                                  Gosselin Nadège          +32 2 7741690
                                  Govaerts Anne-Sophie     +32 2 7741041
                                  Grimonpont Cristel       +32 2 7741064
                                  Gulyban Akos             +32 2 7741052
                                  Hall Jacqueline          +32 2 7741658
                                  Harrison Jillian         +32 2 7741051
                                  Hasan Baktiar            +32 2 7741642
182                               Henot Frédéric           +32 2 7741655
                                  Hermans Catherine        +32 2 7741070
                                  Hons Sophie              +32 2 7741611
                                  Jablonka Ariane          +32 2 7741050
                                  Jacques Aurore           +32 2 7741687
                                  Jagiello Izabella        +32 2 7741688
                                  Jamine David             +32 2 7741033
                                  Janiaud Emilie           +32 2 7741636
                                  Janssen Sven             +32 2 7741609
                                  Jeglikova Petra          +32 2 7741098
                                  Jinah Saïda              +32 2 7741650
                                  Kamp Bernard             +32 2 7741616
                                  Karrasch Matthias        +32 2 7741653
                                  Kirkpatrick Anne         +32 2 7741691
                                  Kirova Teodora           +32 2 7741080
                                  Lacombe Denis            +32 2 7741635
6. EORTC Director y Conferences

                                  Lapaige Michel           +32 2 7741025
                                  Le Polain Sandrine       +32 2 7741038
                                  Lejeune Stephane         +32 2 7741075
                                  Lentz Marie-Ange         +32 2 7741626
         Courses &

                                  Liberatoscioli Cecilia   +32 2 7741005
                                  Lidarssi Michèle         +32 2 7741010
                                  Locci Donatella          +32 2 7741611
                                  Marchal Benedicte        +32 2 7741078
                                  Maringwa John            +32 2 7741633
Marinus Ann              +32 2 7741654
Marques Marta            +32 2 7741054
Marreaud Sandrine        +32 2 7741685
Martinelli Francesca     +32 2 7741619
Mauer Murielle           +32 2 7741006
Meert Liv                +32 2 7741058
Meeus Marie-Anne         +32 2 7741644
Meirlaen Lies            +32 2 7741045
Meloen Sara              +32 2 7741048
Meulemans Bart           +32 2 7741079
Meunier Francoise        +32 2 7741630
Migaszewski Guillaume    +32 2 7741069
Minas Vicky              +32 2 7741657
Morren Sarah             +32 2 7741639
Mortier Steven           +32 2 7741607          183
Negrouk Anastassia       +32 2 7741017
Neven Elke               +32 2 7741673
Nzokirantevye Axelle     +32 2 7741662   axelle.nzokirantevye
O’Sullivan Jonathan      +32 2 7741686
Olungu Christine         +32 2 7741097
Othmezouri Nicolas       +32 2 7741020
Ouali Monia              +32 2 7741055
Peeters Francoise        +32 2 7741675
Penninckx Björn          +32 2 7741059
Pierart Marianne         +32 2 7741603
Polders Larissa          +32 2 7741056
Pontegnies Carine        +32 2 7741023
Pourbaix Angélique       +32 2 7741608   angé
Praet Michel             +32 2 7741672
Quinten Chantal          +32 2 7741631
                                                                          5. EORTC Courses y Conferences

Rapion Jerome            +32 2 7741606
Rasier Daphné            +32 2 7741696
Raveloarivahy Tiana      +32 2 7741622
Rigaux Françoise         +32 2 7741634
                                                                                   Director &

Rossi Séraphine          +32 2 7741068
Ruyskart Pascal          +32 2 7741620
Sanderson-Scott Sheila   +32 2 7741057
Shaukat Sebina           +32 2 7741013
Siké Alvine              +32 2 7741651
                                  Siraut Aurélia            +32 2 7741697
                                  Solbu Gabriel             +32 2 7741674
                                  Steuve Jonathan           +32 2 7741039
                                  Suciu Stefan              +32 2 7741605
                                  Sylvester Richard         +32 2 7741613
                                  Szternfeld Pascale        +32 2 7741035
                                  Tayah Zeina               +32 2 7741643
                                  Tridello Gloria           +32 2 7741028
                                  Valkaert Thomas           +32 2 7741026
                                  Van Den Bergh Jouri       +32 2 7741034
                                  Van Den Bossche Katrien   +32 2 7741627
                                  Van Glabbeke Martine      +32 2 7741625
                                  Van Gorp Delphine         +32 2 7741009
                                  Vandergooten Stephanie    +32 2 7741074
184                               Vandermaelen Christelle   +32 2 7741614
                                  Vanhee Michel             +32 2 7741018
                                  Vanhemelryck Laura        +32 2 7741091
                                  Vercauteren Jurgen        +32 2 7741084
                                  Verleye Leen              +32 2 7741073
                                  Veyt Ellen                +32 2 7741024
                                  Vinckx Vinciane           +32 2 7741032
                                  von Frenckell Remy        +32 2 7741016
                                  Wanko Caroline            +32 2 7741634
                                  Waterkeyn Christine       +32 2 7741617
                                  Werutsky Gustavo          +32 2 7741085
                                  Williams Sarah            +32 2 7741667
                                  Wyns Cindy                +32 2 7741019
                                  Yannopoulos Alexia        +32 2 7741611
                                  Zimmermann Danielle       +32 2 7741602
6. EORTC Director y Conferences
5.       Courses &
EORTC Officers Directory
Agnew Victoria                                    Andry Guy
Ex-Officio Member EORTC Board                     Treasurer EORTC Head and Neck Cancer
Member EORTC General Assembly                     Group
The EORTC Charitable Trust                        Institut Jules Bordet
211 Piccadilly                                    Dept. de Chirurgie
GB London W1J 9HF                                 Rue Heger-Bordet, 1
United Kingdom                                    BE 1000 Brussels
Tel: +44 20 79179571                              Belgium
Fax: +44 20 74390262                              Tel: +32 2 5413161 / 5413159                    Fax: +32 2 5413176
Amadori Sergio
Trial Coordinator (06031)                         Ang Kian
Azienda Ospedallera Universitaria - Policlinico   Member EORTC Scientific Audit Committee
Tor Vergata                                       Md Anderson Cancer Center
Dept of Hematoloy                                 Radiation oncology                        185
Viale Oxford, 81                                  1515 Holcombe Boulevard - Box 97
IT 00133 Roma                                     US Houston TX 77030-4009
Italy                                             U.S.A.
Tel: +39 06 20903218 // 19
Fax: +39 06 20903221                              Ardill Joy                       Secretary EORTC Quality of Life Group
                                                  Royal Hospital
Anderson Brendon                                  Reg. Regu. Peptide Labo.
Trial Coordinator (22033)                         Grosvenor Road
Canterbury District Health Board                  GB Belfast BT12 6BA
Oncology                                          United Kingdom
Riccarton Avenue                                  Tel: +44 2890 632515 // 632533
NZ Christchurch                                   Fax: +44 2890 235900
New Zealand                             

Andre Fabrice                                     Armand Jean-Pierre
Member EORTC General Assembly                     Member EORTC Protocol Review Committee
Institut Gustave Roussy                           Centre Claudius Regaud
39, rue Camille Desmoulins                        20-24, rue du Pont St Pierre
                                                                                            5. EORTC Courses y Conferences
FR 94805 Villejuif CEDEX                          FR 31052 Toulouse CEDEX
France                                            France
                                                  Tel: +33 561424101
                                                  Fax: +33 561592928
                                                                                            6.       Director &
                                  Awada Ahmad                                      Benoit Yves
                                  Member EORTC General Assembly                    Member EORTC General Assembly
                                  Member EORTC Independent Data Monitoring         Chairman EORTC Children’s Leukemia Group
                                  Committee                                        Universiteit Gent
                                  Member EORTC New Drug Advisory                   Ped. Hemato/Oncology
                                  Committee                                        De Pintelaan 185
                                  Institut Jules Bordet                            BE 9000 Gent
                                  Dept de Chimiotherapie                           Belgium
                                  Rue Heger-Bordet, 1                              Tel: +32 9 3323576
                                  BE 1000 Brussels                                 Fax: +32 9 3323448
                                  Tel: +32 2 5413189
                                  Fax: +32 2 5380858                               Bernier Jacques
                                                    Member EORTC Protocol Review Committee
                                                                                   Clinique De Genolier
                                  Bagot Martine                                    CH 1272 Genolier
                                  Member EORTC General Assembly                    Switzerland
                                  Chairman EORTC Cutaneous Lymphoma Task           Tel: +41 22 3669959
                                  Force                                            Fax: +41 22 3669961
186                               C.H.U. Henri Mondor AP-HP              
                                  Dept of Dermatology
                                  51, av. Marechal de Lattre de Tassigny           Bertrand Yves
                                  FR 94010 Creteil                                 Secretary EORTC Children’s Leukemia Group
                                  France                                           CHU Lyon - Institut d’Hematologie et
                                  Tel: +33 149812504                               d’Oncologie Pediatrique
                                  Fax: +33 149812508                               1, Place Joseph Renaut
                                                FR 69008 Lyon CEDEX
                                  Banerji Udai                                     Tel: +33 469166569
                                  Member EORTC New Drug Advisory                   Fax: +33 478782703
                                  Royal Marsden Hospital
                                  Downs Road                                       Biesma Bonne
                                  GB Sutton (Surrey) SM2 5PT                       Treasurer EORTC Lung Cancer Group
                                  United Kingdom                                   Jeroen Bosch Ziekenhuis
                                  Tel: +44 2086423984                              Dept of Pulmonology
                                  Fax: +44 2086613541                              Nieuwstraat 34 - Postbus 90153
                                                   NL 5211 NL ‘S Hertogenbosch
6. EORTC Director y Conferences

                                                                                   The Netherlands
                                  Baumert Brigitta                                 Tel: +31 73 6992441
                                  Trial Coordinator (26053, 22033)                 Fax: +31 73 6992614
                                  Secretary EORTC Brain Tumor Group      
                                  Maastro Clinic - Maastricht Radiation Oncology
         Courses &

                                  Radiotherapeut Oncoloog
                                  P.O. Box 3035 (Dr Tanslan 12)
                                  NL 6202 NA Maastricht
                                  The Netherlands
                                  Tel: +31 88 4455666
                                  Fax: +31 88 4455667
Blay Jean-Yves                           Bron Dominique
President EORTC Board                    Member EORTC Scientific Audit Committee
President EORTC General Assembly         Institut Jules Bordet
Centre Leon Berard                       Dept of Hematology
Department of Medicine                   Rue Heger-Bordet, 1
28, rue Laennec                          BE 1000 Brussels
FR 69008 Lyon                            Belgium
France                                   Tel: +32 2 5413212
Tel: +33 478782757                       Fax: +32 2 5440257
Fax: +33 478782716             
                                         Burger Angelika
Bodis Stephan                            Member EORTC New Drug Advisory
Member EORTC Protocol Review Committee   Committee
Kantonsspital Aarau                      University of Maryland School of Medicine
Institute of Radiation Oncology          Pharmacology & Exp. Therapeutics, Bressler
CH 5001 Aarau                            Research Building, Rm 9-039
Switzerland                              22,South Greene Street
Tel: +41 62 8385408 // 5371              US 21201 Baltimore - Maryland
Fax: +41 62 8385223                      U.S.A.
                                                                                      187                     Tel: +1 410 3283914 / 8091
                                         Fax: +1 410 3286559
Bolla Michel                   
Trial Coordinator (22043)
Chr De Grenoble - La Tronche             Cameron David
Dept de Radiotherapie                    Trial Coordinator (10054)
BP 217 X                                 Secretary EORTC Breast Cancer Group
FR 38043 Grenoble CEDEX                  NCRN Coordinating Centre - University of
France                                   Leeds
Tel: +33 476765435                       Director of NCRN
Fax: +33 476765629 // 7555               24 Hyde Terrace                   GB Leeds LS2 9LN
                                         United Kingdom
Bonnefoi Herve                           Tel: +44 113 3438033
Trial Coordinator (10054)                Fax: +44 113 3432242
Member EORTC General Assembly  
Institut Bergonie
Department of medical oncology           Carde Patrice                                5. EORTC Courses y Conferences
229, cours de l’Argonne                  Trial Coordinator (20012)
FR 33076 Bordeaux CEDEX                  Institut Gustave Roussy
France                                   Dept of Medecine C
Tel: +33 556337817                       39, rue Camille Desmoulins
Fax: +33 556333330                       FR 94805 Villejuif CEDEX
                                                                                               Director &                    France
                                         Tel: +33 142114321
                                         Fax: +33 142115270
                                  Cardoso Fatima                               Chatelut Etienne
                                  Trial Coordinator (10041)                    Secretary EORTC Pharmacology & Molecular
                                  Secretary EORTC Scientific Audit Committee   Mechanisms Group
                                  Member EORTC Translational Research          Centre Claudius Regaud
                                  Advisory Committee                           Unit‚ Pharmacocinetique
                                  Institut Jules Bordet                        20-24, rue du Pont St Pierre
                                  Dept of Medical Oncology & Translational     FR 31052 Toulouse CEDEX
                                  Research                                     France
                                  Rue Heger-Bordet, 1                          Tel: +33 561424271
                                  BE 1000 Brussels                             Fax: +33 561424631
                                  Tel: +32 2 5413082
                                  Fax: +32 2 5380858                           Collette Laurence
                                             Member EORTC Quality Assurance Committee
                                  Casado Herraez Antonio                       Statistician
                                  Member EORTC General Assembly                Avenue E. Mounier 83, bte 11
                                  Chairman EORTC Gynecological Cancer Group    BE 1200 Brussels
                                  Hospital Universitario San Carlos            Belgium
188                               Dept of Medical Oncology                     Tel: +32 2 7741669
                                  C/ Profesor Martin Lagos, s/n                Fax: +32 2 7713810
                                  ES 28040 Madrid                    
                                  Tel: +34 91 3303666 // 3303541               Colombo Alessandro
                                  Fax: +34 91 3303546 // 3544                  Trial Coordinator (55994)
                                         Ospedale Alessandro Manzoni
                                                                               Via dell’Eremo 9/11
                                  Cassidy Jim                                  IT 23900 Lecco
                                  Member EORTC Protocol Review Committee       Italy
                                  University Of Glasgow - Cancer Research Uk
                                  Dept of Medical Oncology
                                  Garscube Estate, Switchback Road             Conroy Thierry
                                  GB Bearsden - Glasgow G61 1BD                Member EORTC Membership Committee
                                  United Kingdom                               Centre Alexis Vautrin
                                  Tel: +44 141 3304890                         Medical Oncology
                                  Fax: +44 141 3304127                         Avenue de Bourgogne, Brabois
                                          FR 54511 Vandoeuvre-Les-Nancy CEDEX
6. EORTC Director y Conferences

                                  Celis Julio                                  Tel: +33 383598460
                                  Member EORTC Scientific Audit Committee      Fax: +33 383598550
                                  Danish Cancer Society              
                                  Institute of Cancer Biology
                                  Strandboulevarden 49
         Courses &

                                  DK 2100 Copenhagen
                                  Tel: +45 35257363
                                  Fax: +45 35257721
Cornely Oliver                                    Daidone Maria Grazia
Trial Coordinator (65031)                         Member EORTC General Assembly
Universitaetskliniken Koeln                       Chairman EORTC Pathobiology Group
Kerpener Strasse 62                               Member EORTC Translational Research
DE 50924 Koeln                                    Advisory Committee
Germany                                           Istituto Nazionale Per Lo Studio E La Cura Dei
Tel: +49 221 4786209                              Tumori
Fax: +49 221 4783611                              Dept of Experimental Oncology                       Via Venezian, 1
                                                  IT 20133 Milano
Craft Alan W.                                     Italy
Member EORTC Protocol Review Committee            Tel: +39 02 23902238
Royal Victoria Infirmary                          Fax: +39 02 23903052
Children’s Department                   
Queen Victoria Road
GB Newcastle-Upon-Tyne NE1 4LP                    Dancey Janet
United Kingdom                                    Member EORTC New Drug Advisory
Tel: +44 191 2023010                              Committee
Fax: +44 191 2023022                              Ncic Clinical Trials Group - Queen’S University                         Dpt of Oncology
                                                  10 Stuart Street
Crawley Francis                                   CA Kingston ONTARIO K7L 3N6
Member EORTC Headquarters - Institutional         Canada
Review Board                                      Tel: +1 6135336430
Good Clinical Practice Alliance                   Fax: +1 6135332411
Schoolbergenstraat, 47                  
BE B - 3010 LEUVEN
Belgium                                           Daugaard Gedske
                                                  Trial Coordinator (30061)
Cufer Tanja                                       Rigshospitalet
Trial Coordinator (10071)                         Dept of Medical Oncology
Member EORTC General Assembly                     Blegdamsvej 9
Chairman EORTC Breast Cancer Group                DK 2100 Copenhagen
The University Clinic of Pulmonary and Allergic   Denmark
Diseases Golnik                                   Tel: +45 35454677 / 35451125
Department of Oncology                            Fax: +45 35456966
Golnik 36                               
SI 4204 Golnik                                                                                      5. EORTC Courses y Conferences
Slovenia                                          De Bock Robrecht
Tel: +386 4 2569499                               Treasurer EORTC Infectious Diseases Group
Fax: +386 4 2569384                               ZNA Middelheim                     Dept of Hematology
                                                  Lindendreef 1
                                                                                                             Director &

                                                  BE 2020 Antwerpen
                                                  Tel: +32 3 2803484
                                                  Fax: +32 3 2810800
                                  De Jonge Maja                                Debiec-Rychter Maria
                                  Member EORTC Protocol Review Committee       Member EORTC Translational Research
                                  Member EORTC New Drug Advisory               Advisory Committee
                                  Committee                                    U.Z. Gasthuisberg
                                  Erasmus University Medical Center            Human Genetics
                                  Medical Oncology                             Herestraat 49
                                  Postbus 5201 (Groene Hilledijk 301)          BE 3000 Leuven
                                  NL 3008 AE Rotterdam                         Belgium
                                  The Netherlands                              Tel: +32 16 347218
                                  Tel: +31 10 7041760                          Fax: +32 16 346063
                                  Fax: +31 10 7041003                
                                                                               den Dulk Marcel
                                  De Wit Ronald                                Member EORTC Quality Assurance Committee
                                  Trial Coordinator (30983)                    Leiden University Medical Centre
                                  Member EORTC General Assembly                Albinusdreef 2 - Postbus 9600
                                  Erasmus University Medical Center            NL 2300 RC Leiden
                                  Dept. of Medical Oncology                    The Netherlands
                                  Postbus 5201 (Groene Hilledijk 301)          Tel: +31 715267306
190                               NL 3008 AE Rotterdam               
                                  The Netherlands
                                  Tel: +31 10 7041760                          Dhingra Kapil
                                  Fax: +31 10 7041003                          Member EORTC New Drug Advisory
                                                                               KAPital Consulting LLC
                                  De Witte Theo                                8 Baldwin Dew Ct
                                  Trial Coordinator (06071)                    US Sparta N307871
                                  Member EORTC General Assembly                U.S.A.
                                  Member EORTC Protocol Review Committee
                                  Member EORTC Membership Committee            Dieras Veronique
                                  Member EORTC Translational Research          Member EORTC General Assembly
                                  Advisory Committee                           Member EORTC Protocol Review Committee
                                  Radboud University Nijmegen Medical Centre   Institut Curie
                                  Dept of Hematology                           Departement d’Oncologie Medicale
                                  P.O. Box 9101 - Geert Grooteplein 10         26, rue d’Ulm
                                  NL 6500 HB Nijmegen                          FR 75231 Paris CEDEX 05
                                  The Netherlands                              France
                                  Tel: +31 24 3614762                          Tel: +33 144324675 // 4677
6. EORTC Director y Conferences

                                  Fax: +31 24 3542080                          Fax: +33 144324671
5.       Courses &
Dittmer J.                                      Dumez Herlinde
Secretary EORTC Pathobiology Group              Member EORTC Protocol Review Committee
Martin Luther Universitaet                      U.Z. Gasthuisberg
Klinik fuer Gynaekologie                        Dept of Oncology
Ernst-Grube-Str. 40                             Herestraat 49
DE 06120 Halle /SAALE                           BE 3000 Leuven
Germany                                         Belgium
Tel: +49 345 5571338                            Tel: +32 16 346900
Fax: +49 345 5575261                            Fax: +32 16 346901  

Dittrich Christian                              Dummer Reinhard
Member EORTC Scientific Audit Committee         Trial Coordinator (21012)
Member EORTC Protocol Review Committee          Universitaetsspital
Kaiser Franz Josef Spital                       Dept of Dermatology
LBI - ACR Vienna                                Raemistrasse 100
Kundratstr. 3                                   CH 8091 Zurich
AT 1100 Vienna                                  Switzerland
Austria                                         Tel: +41 44 2552507
Tel: +43 1 60191 ext 2301/2324                  Fax: +41 44 2558988
Fax: +43 1 60191 ext 2329/2309        
                                                Eckhardt Gail
Donnelly Peter                                  Member EORTC Protocol Review Committee
Member EORTC General Assembly                   University Of Colorado Cancer Center
Chairman EORTC Infectious Diseases Group        Development Therapeutics Program
Radboud University Nijmegen Medical Centre      4200 E 9th Avenue
Dept. of Hematology                             US Denver CO 80262
P.O. Box 9101 - Geert Grooteplein 10            U.S.A.
NL 6500 HB Nijmegen                             Tel: +1 303 3150882
The Netherlands                       
Tel: +31 24 3619987
Fax: +31 24 3542080                             Efficace Fabio                              Secretary EORTC Quality of Life Group
                                                Universita Degli Studi “la Sapienza”
Ducreux Michel                                  IME - Department of Hematology
Secretary EORTC Gastrointestinal Tract Cancer   Via Benevento 6
Group                                           IT 00161 Roma                            5. EORTC Courses y Conferences
Institut Gustave Roussy                         Italy
Gastroenterologie                               Tel: +39 06 441639850
39, rue Camille Desmoulins                      Fax: +39 06 4402516
FR 94805 Villejuif CEDEX              
                                                                                                  Director &

Tel: +33 142114308/142115042
Fax: +33 142115228
                                  Eggermont Alexander                               Ferster Alice
                                  Trial Coordinator (18071)                         Trial Coordinator (58051)
                                  Member EORTC Board                                Hopital Universitaire Des Enfants Reine Fabiola
                                  Member EORTC General Assembly                     Dept Hemato-Oncologie
                                  Chairman EORTC Membership Committee               Avenue J.J. Crocq, 15
                                  Erasmus University Medical Center                 BE 1020 Brussels
                                  Dept of Surgical Oncology                         Belgium
                                  Postbus 5201 (Groene Hilledijk 301)               Tel: +32 2 4773282
                                  NL 3008 AE Rotterdam                              Fax: +32 2 4772678
                                  The Netherlands                         
                                  Tel: +31 10 7041911 / 1506
                                  Fax: +31 10 7041011                               Foekens John A.
                                              Member EORTC Translational Research
                                                                                    Advisory Committee
                                  Eisenhauer Elisabeth                              Erasmus Medical Center -
                                  Member EORTC Scientific Audit Committee           Josephine Nefkens Institute - Dept Med.
                                  Ncic Clinical Trials Group - Queen’S University   Oncology
                                  10 Stuart Street                                  P.O. Box 1738 - (Dr Molewaterplein 50)
                                  CA Kingston ONTARIO K7L 3N6                       NL 3000DR Rotterdam
192                               Canada                                            The Netherlands
                                  Tel: +1 613 5336430                               Tel: +31 10 4088369
                                  Fax: +1 613 5332411                               Fax: +31 10 4088365 // 377

                                  Faivre-Finn Corinne                               Fumoleau Pierre
                                  Trial Coordinator (08072)                         Member EORTC General Assembly
                                  Christie Hospital                                 Centre Georges-Francois-Leclerc
                                  Clinical Oncology                                 Medical Oncology
                                  Wilmslow Road                                     1, rue du Professeur Marion - B.P. 77980
                                  GB Manchester M20 4BX                             FR 21079 Dijon CEDEX
                                  United Kingdom                                    France
                                  Tel: +44 161 4468200                              Tel: +33 380737506
                                  Fax: +44 161 4468142                              Fax: +33 380737716

                                  Fennell Dean                                      Gelderblom Hans
                                  Member EORTC Board                                Member EORTC General Assembly
                                  Member EORTC General Assembly                     Member EORTC Board
6. EORTC Director y Conferences

                                  Belfast City Hospital                             Leiden University Medical Centre
                                  Centre for Cancer Research & Cell Biology         Oncology, Bldg 1.K1-P51
                                  Lisburn Road                                      Albinusdreef 2 - Postbus 9600
                                  GB Belfast BT9 7AB                                NL 2300 RC Leiden
                                  United Kingdom                                    The Netherlands
         Courses &

                                  Tel: +44 28 90263911                              Tel: +31 71 5263486
                                  Fax: +44 28 90263727                              Fax: +31 71 5266760
Geurts-Moespot Anneka                            Greillier Laurent
Treasurer EORTC Pathobiology Group               Member EORTC Quality Assurance Committee
Radboud University Nijmegen Medical Centre       Chu De Marseille - Hopital Sainte-Marguerite
Dept. Chemical Endocrino.                        Service de Pneumologie et d’Oncologie
P.O. Box 9101 - Geert Grooteplein 10             Thoracique
NL 6500 HB Nijmegen                              270 Bd de Sainte-Marguerite - BP 29
The Netherlands                                  FR 13274 Marseille CEDEX 9
Tel: +31 24 3614275                              France
Fax: +31 24 3541484                              Tel: +33 491744736                             Fax: +33 491745524
Ghanem G.
Treasurer EORTC Melanoma Group                   Griffiths Gareth
Institut Jules Bordet                            Member EORTC Independent Data Monitoring
Oncology & Exp. Surgery                          Committee
Rue Heger-Bordet, 1                              University Of Wales College Of Medicine
BE 1000 Brussels                                 Wales Cancer Trials Unit, Neuadd Meirionnydd
Belgium                                          Heath Park
Tel: +32 2 5413296                               GB UK Cardiff CF14 4XN
Fax: +32 2 5413349                               United Kingdom
                                                                                                  193                         Tel: +44 20687456
                                                 Fax: +44 20687501
Greggi Stefano                         
Trial Coordinator (55994)
Istituto Nazionale Per Lo Studio E La Cura Dei   Gronchi Alessandro
Tumori                                           Trial Coordinator (62063)
Via M. Semmola, 3                                Istituto Nazionale Per Lo Studio E La Cura Dei
IT 80131 Napoli                                  Tumori
Italy                                            Sarcoma Unit, Department of Surgery
Tel: +39 081 5903320                             Via Venezian, 1
Fax: +39 081 5903851                             IT 20133 Milano                                  Italy
                                                 Tel: +39 02 23903234
Gregoire Vincent                                 Fax: +39 02 23902404
Member EORTC General Assembly          
Chairman EORTC Radiation Oncology Group
Cliniques Universitaires St. Luc                 Guillemin Francois
IMRE 54/69                                       Member EORTC Protocol Review Committee           5. EORTC Courses y Conferences
Avenue Hippocrate, 10                            Centre Alexis Vautrin
BE 1200 Brussels                                 Avenue de Bourgogne, Brabois
Belgium                                          FR 54511 Vandoeuvre-Les-Nancy CEDEX
Tel: +32 2 7649443                               France
Fax: +32 2 7649425                               Tel: +33 383598487
                                                                                                           Director &                    Fax: +33 383446071
                                  Hall Jacqueline                                Haustermans Karin
                                  Ex-Officio Member EORTC Translational          Trial Coordinator (40054)
                                  Research Advisory Committee                    Member EORTC General Assembly
                                  EORTC                                          Member EORTC Board
                                  Avenue E. Mounier 83, bte 11                   Chairman EORTC Quality Assurance
                                  BE 1200 Brussels                               Committee
                                  Belgium                                        U.Z. Gasthuisberg
                                  Tel: +32 2 7741658                             Dept of Radiotherapy
                                  Fax: +32 2 7723545                             Herestraat 49
                                               BE 3000 Leuven
                                  Hamoir Marc                                    Tel: +32 16 346902
                                  Member EORTC General Assembly                  Fax: +32 16 346901
                                  Cliniques Universitaires St. Luc     
                                  Head and Neck Surgery
                                  Avenue Hippocrate, 10                          Hill Catherine
                                  BE 1200 Brussels                               Member EORTC Protocol Review Committee
                                  Belgium                                        Institut Gustave Roussy
                                  Tel: +32 2 7641974                             39, rue Camille Desmoulins
194                               Fax: +32 2 7648935                             FR 94805 Villejuif CEDEX
                                                                                 Tel: +33 142114136
                                  Harbeck Nadia                                  Fax: +33 142115258
                                  Member EORTC General Assembly        
                                  Member EORTC Board
                                  Chairman Translational Research Division       Hirte Halger Wolfgang
                                  Ex-Officio Member EORTC Translational          Member EORTC Protocol Review Committee
                                  Research Advisory Committee                    Hamilton Health Sciences, Juravinski Cancer
                                  Ex-Officio Member EORTC New Drug Advisory      Centre
                                  Committee                                      Medical Oncology
                                  Member EORTC Executive Committee               Hamilton Health Sciences, 699 Concession
                                  Universitaetskliniken Koeln                    Street
                                  Klinik & Poliklinik fuer Frauenheilkunde und   CA Hamilton ONTARIO L8V 5C2
                                  Geburtshilfe                                   Canada
                                  Kerpener Strasse 62                            Tel: +1 905 3879711 ext 67680
                                  DE 50924 Koeln                                 Fax: +1 905 5756326
                                  Tel: +49 221 47897303
6. EORTC Director y Conferences

                                  Fax: +49 221 47886546                          Hoekstra Otto Sies
                                              Member EORTC Translational Research
                                                                                 Advisory Committee
                                                                                 Vrije Universiteit Medisch Centrum
                                                                                 Dept Nuclear Medicine/Clin PET Centre (5A86)
         Courses &

                                                                                 P.O. Box 7057 -(De Boelelaan 1117)
                                                                                 NL 1007MB Amsterdam
                                                                                 The Netherlands
                                                                                 Tel: +31 20 4444214
                                                                                 Fax: +31 20 4443090
Hohenberger Peter                               Jaeger Elke
Member EORTC General Assembly                   Member EORTC Protocol Review Committee
Chairman EORTC Soft Tissue and Bone             Krankenhaus Nordwest
Sarcoma Group                                   Haematologie / Onkologie
UniversitaetsMedizin Mannheim                   Steinbacher Hohl, 2-26
Dept of Surgery, Surgical Oncology & Thoracic   DE 60488 Frankfurt Am Main
Surgery                                         Germany
Theodor-Kutzer-Ufer 1 - 3                       Tel: +49 69 76013380
DE 68167 Mannheim                               Fax: +49 69 769932
Tel: +49 621 3832609
Fax: +49 621 3831479                            Jassem Jacek                          Treasurer EORTC Board
                                                Member EORTC General Assembly
Horiot Jean-Claude                              Treasurer EORTC Executive Committee
Member EORTC General Assembly                   Medical University Of Gdansk
Ex-Officio Member EORTC Board                   Oncology & Radiotherapy
Clinique De Genolier                            Ul. Debinki 7
CH 1272 Genolier                                PL 80 211 Gdansk
Switzerland                                     Poland
Tel: +41 22 3669458                             Tel: +48 58 3492270                           Fax: +48 58 5203899
Iggo Richard
Member EORTC Translational Research             Joniau Steven
Advisory Committee                              Trial Coordinator (30072)
University of St Andrews - The Bute Medical     U.Z. Gasthuisberg
School                                          Dept of Urology, Uro-oncology and
Bute Building - Westburn Lane                   Reconstructive Urology
GB Fife, St Andrews KY16 9TS                    Herestraat 49
United Kingdom                                  BE 3000 Leuven
Tel: +44 1334 463558                            Belgium
Fax: +44 1334 463482                            Tel: +32 16 346945                           Fax: +32 16 346931
Isambert Nicolas
Member EORTC Protocol Review Committee          Judson Ian Robert
Centre Georges-Francois-Leclerc                 Trial Coordinator (62012)                5. EORTC Courses y Conferences
1, rue du Professeur Marion - B.P. 77980        Member EORTC Protocol Review Committee
FR 21079 Dijon CEDEX                            Royal Marsden Hospital
France                                          Sarcoma Unit
                                                Fulham Road 203
                                                GB London SW3 6JJ
                                                                                                  Director &

                                                United Kingdom
                                                Tel: +44 20 87224302
                                                Fax: +44 20 73490701
                                  Kaplan Richard                               Keus Ronald
                                  Member EORTC Board                           Member EORTC General Assembly
                                  Member EORTC General Assembly                Arnhem ‘S Radiotherapeutisch Instituut
                                  Chairman EORTC Independent Data Monitoring   Wagnerlaan 47
                                  Committee                                    NL 6815 AD Arnhem
                                  NCRN Coordinating Centre - University of     The Netherlands
                                  Leeds                                        Tel: +31 26 3712412
                                  Associate Director                           Fax: +31 26 4431200
                                  24 Hyde Terrace                    
                                  GB Leeds LS2 9LN
                                  United Kingdom                               Knecht Rainald
                                  Tel: +44 113 3436668                         Secretary EORTC Head and Neck Cancer
                                  Fax: +44 113 3432242                         Group
                                                 Universitaets-Krankenhaus Eppendorf
                                                                               Klinik und poliklinik fuer Hals-, Nasen- und
                                  Katsaros Dionyssios                          Ohrenheilkunde
                                  Secretary EORTC Gynecological Cancer Group   Martinistrasse 52
                                  Clinica Universita                           DE 20246 Hamburg
                                  Via Ventimiglia, 3                           Germany
196                               IT 10126 Torino                              Tel: +49 40 42803-2360
                                  Italy                                        Fax: +49 40 42803-6319
                                  Tel: +39 011 3131996               
                                  Fax: +39 011 6647910
                                                      Kynaston Howard
                                                                               Secretary EORTC Genito-Urinary Tract Cancer
                                  Kenter Gemma                                 Group
                                  Trial Coordinator (55994)                    University Of Wales College Of Medicine
                                  Leiden University Medical Centre             Dept of Urology
                                  Albinusdreef 2 - Postbus 9600                Heath Park
                                  NL 2300 RC Leiden                            GB UK Cardiff CF14 4XN
                                  The Netherlands                              United Kingdom
                                  Tel: +31 71 5263332                          Tel: +44 29 20745094
                                  Fax: +31 71 5248181                          Fax: +44 29 20744179

                                  Kerr Keith M.
                                  Member EORTC Translational Research
                                  Advisory Committee
6. EORTC Director y Conferences

                                  University Medical School - NHS Grampian
                                  Dept of Pathology
                                  GB Aberdeen AB25 2ZD
                                  United Kingdom
         Courses &

                                  Tel: +44 1224 552414 // 550948
                                  Fax: +44 1224 663002
Lacombe Denis                                    Langendijk Johannes
Ex-Officio Member EORTC New Drug Advisory        Member EORTC General Assembly
Committee                                        Chairman EORTC Head and Neck Cancer
Ex-Officio Member EORTC Protocol Review          Group
Committee                                        University Medical Center Groningen
Chairman EORTC Headquarters - Institutional      Radiation Oncology
Review Board                                     Postbus 30001 (Hanzeplein 1)
Ex-Officio Member EORTC Executive                NL 9700 RB Groningen
Committee                                        The Netherlands
EORTC                                            Tel: +31 50 3611190
Scientific Director                              Fax: +31 50 3611692
Avenue E. Mounier 83, bte 11           
BE 1200 Brussels
Belgium                                          Larsen Annette
Tel: +32 2 7741635                               Treasurer EORTC Pharmacology & Molecular
Fax: +32 2 7795097                               Mechanisms Group                           Hopital Saint Antoine (AP-HP)
                                                 Group of Molecular & Clin. Cancer Therapeutics,
Lambin Philippe                                  INSERM U673
Member EORTC Translational Research              184 rue du Faubourg St Antoine
Advisory Committee                               FR 75571 Paris
Maastro Clinic - Maastricht Radiation Oncology   France
Radiation - Oncology                             Tel: +33 149284612 //4674
P.O. Box 3035 (Dr Tanslan 12)                    Fax: +33 142226429
NL 6202 NA Maastricht                  
The Netherlands
Tel: +31 88 4455753                              Leahy Michael G.
Fax: +31 88 5566667                              Member EORTC Quality Assurance Committee                       Christie Hospital
                                                 Wilmslow Road
Landoni Fabio                                    GB Manchester M20 4BX
Trial Coordinator (55994)                        United Kingdom
Istituto Europeo Di Oncologia                    Tel: +44 161 4468384
Dept of Gynecology                               Fax: +44 161 4463478
Via Ripamonti, 435                     
IT 20141 Milano
Italy                                            Leer Jan W. H.
Tel: +39 02 57489542                             Member EORTC Membership Committee                 5. EORTC Courses y Conferences
Fax: +39 02 57489211                             Radboud University Nijmegen Medical Centre                             Dept of Radiation Oncology
                                                 P.O. Box 9101 - Geert Grooteplein 10
                                                 NL 6500 HB Nijmegen
                                                 The Netherlands
                                                                                                            Director &

                                                 Tel: +31 24 3614023
                                                 Fax: +31 24 3610792
                                  Lejeune Ferdy                                    Littbrand B.
                                  Member EORTC Independent Data Monitoring         Member EORTC Independent Data Monitoring
                                  Committee                                        Committee
                                  Centre Hospitalier Universitaire Vaudois         Umea Universitet
                                  Ctre Pluridisc. Oncologie                        Dept of Oncology
                                  rue du Bugnon 46                                 SE 901 87 Umea
                                  CH 1011 Lausanne                                 Sweden
                                  Switzerland                                      Tel: +46 90 7865244
                                                Fax: +46 90 7867790
                                  Leyvraz Serge
                                  Trial Coordinator (18021)                        Luebbert Michael
                                  Centre Hospitalier Universitaire Vaudois         Secretary EORTC Leukemia Group
                                  Dept d‘Oncologie - niv.10                        Universitaetsklinikum Freiburg
                                  rue du Bugnon 46                                 Medicine -Hemato/Oncology
                                  CH 1011 Lausanne                                 Hugstetterstrasse 49
                                  Switzerland                                      DE 79106 Freiburg
                                  Tel: +41 21 3140150                              Germany
                                  Fax: +41 21 3140181                              Tel: +49 761 2703279
198                                                 Fax: +49 761 2703697
                                  Licitra Lisa
                                  Member EORTC Board                               Lutz Patrick
                                  Member EORTC General Assembly                    Treasurer EORTC Children‘s Leukemia Group
                                  Istituto Nazionale Per Lo Studio E La Cura Dei   Hopital Universitaire Hautepierre
                                  Tumori                                           Service de Pediatrie 1
                                  Div. Oncologia Medica                            Rue Moliere
                                  Via Venezian, 1                                  FR 67098 Strasbourg
                                  IT 20133 Milano                                  France
                                  Italy                                            Tel: +33 388128090
                                  Tel: +39 02 23902805                             Fax: +33 388128092
                                  Fax: +39 02 23902804                   
                                                                                   Lutz Manfred
                                  Lievens Yolande                                  Member EORTC General Assembly
                                  Treasurer EORTC Lymphoma Group                   Chairman EORTC Gastrointestinal Tract Cancer
                                  U.Z. Gasthuisberg                                Group
                                  Dept of Radiotherapy                             Caritasklinik St. Theresa
6. EORTC Director y Conferences

                                  Herestraat 49                                    Medical Department
                                  BE 3000 Leuven                                   Rheinstrasse 2
                                  Belgium                                          DE 66113 Saarbrucken
                                  Tel: +32 16 347600                               Germany
                                  Fax: +32 16 347623                               Tel: +49 681 4061001
         Courses &

                                        Fax: +49 681 4061003
Maingon Philippe                           Marinus Ann
Treasurer EORTC Radiation Oncology Group   Secretary EORTC Membership Committee
Centre Georges-Francois-Leclerc            EORTC
Dept of Radiotherapy                       Avenue E. Mounier 83, bte 11
1, rue du Professeur Marion - B.P. 77980   BE 1200 Brussels
FR 21079 Dijon CEDEX                       Belgium
France                                     Tel: +32 2 7741654
Tel: +33 380737517                         Fax: +32 2 7713810
Fax: +33 380362829               
                                           Meijnders Paul
Mallaby Sir Christopher                    Secretary EORTC Lymphoma Group
Ex-Officio Member EORTC Board              ZNA Middelheim
Member EORTC General Assembly              Dep. Hematology-Oncology
Chairman The EORTC Charitable Trust        Lindendreef 1
Warburg Dillon Read                        BE 2020 Antwerpen
1 Shawfield Street                         Belgium
GB UK - LONDON SW3 4BA                     Tel: +32 3 2804019
United Kingdom                             Fax: +32 3 2810719
Mansel Robert
Trial Coordinator (10981)                  Meloni G.
University Of Wales College Of Medicine    Trial Coordinator (06061)
Dept of Surgery                            Universita Degli Studi “la Sapienza”
Heath Park                                 Biotecn. Cell. Ematologia
GB UK Cardiff CF14 4XN                     Via Benevento 6
United Kingdom                             IT 00161 Roma
Tel: +44 29 20742749                       Italy
Fax: +44 29 20761623                       Tel: +39 06 85795773 // 857951                          Fax: +39 06 44241984
Marie Jean-Pierre
Member EORTC General Assembly              Meunier Francoise
Chairman EORTC Leukemia Group              Member EORTC General Assembly
Hotel-Dieu De Paris (AP-HP)                Ex-Officio Member EORTC Board
Dept Hematologie                           Member EORTC Membership Committee
1, place du Parvis Notre-Dame              Member EORTC Scientific Audit Committee
FR 75181 Paris CEDEX 04                    Member EORTC Quality Assurance Committee   5. EORTC Courses y Conferences
France                                     Member EORTC Executive Committee
Tel: +33 142348407                         Ex-Officio Member EORTC Protocol Review
Fax: +33 142348843                         Committee              EORTC
                                           Director-General, EORTC
                                                                                               Director &

                                           Avenue E. Mounier 83, bte 11
                                           BE 1200 Brussels
                                           Tel: +32 2 7741630
                                           Fax: +32 2 7712004
                                  Michiels Stefan                                Negrouk Anastassia
                                  Member EORTC Translational Research            Member EORTC Headquarters - Institutional
                                  Advisory Committee                             Review Board
                                  Institut Gustave Roussy                        EORTC
                                  Service de Biostatistique et d’Epidemiologie   Avenue E. Mounier 83, bte 11
                                  39, rue Camille Desmoulins                     BE 1200 Brussels
                                  FR 94805 Villejuif CEDEX                       Belgium
                                  France                                         Tel: +32 2 7741017
                                                 Fax: +32 2 7741030
                                  Mirimanoff Rene
                                  Member EORTC General Assembly                  Nielsen Ole Steen
                                  Member EORTC Membership Committee              Member EORTC Protocol Review Committee
                                  Centre Hospitalier Universitaire Vaudois       Aarhus University Hospital
                                  Serv. de Radio-Oncologie                       Dept of Oncology
                                  rue du Bugnon 46                               Noerrebrogade 44
                                  CH 1011 Lausanne                               DK 8000 Aarhus C
                                  Switzerland                                    Denmark
                                  Tel: +41 21 3144666                            Tel: +45 89492555
200                               Fax: +41 21 3144664                            Fax: +45 89492550

                                  Mulders Peter                                  Nooij Marianne
                                  Trial Coordinator (30072)                      Trial Coordinator (10031)
                                  Radboud University Nijmegen Medical Centre     Leiden University Medical Centre
                                  Dept of Urology                                Oncology,Bldg 1, K1-P51
                                  P.O. Box 9101 - Geert Grooteplein 10           Albinusdreef 2 - Postbus 9600
                                  NL 6500 HB Nijmegen                            NL 2300 RC Leiden
                                  The Netherlands                                The Netherlands
                                  Tel: +31 24 3613735                            Tel: +31 71 5263486
                                  Fax: +31 24 3541031                            Fax: +31 71 5266760

                                  Muus Petra                                     Nys Herman
                                  Treasurer EORTC Leukemia Group                 Member EORTC Headquarters - Institutional
                                  Radboud University Nijmegen Medical Centre     Review Board
                                  Dept of Hematology                             Centrum voor Biomedische Ethiek en Recht
                                  P.O. Box 9101 - Geert Grooteplein 10           Kapucijnenvoer 35/3
6. EORTC Director y Conferences

                                  NL 6500 HB Nijmegen                            BE 3000 Leuven
                                  The Netherlands                                Belgium
                                  Tel: +31 24 3614762                            Tel: +32 16336951
                                  Fax: +31 24 3542080                            Fax: +32 16336952
5.       Courses &
O’Brien Mary                                 Osanto Suzanne
Trial Coordinator (08052)                    Member EORTC General Assembly
Member EORTC General Assembly                Chairman EORTC Genito-Urinary Tract Cancer
Chairman EORTC Lung Cancer Group             Group
Royal Marsden Hospital                       Leiden University Medical Centre
Lung Unit                                    Clinical Oncology
Downs Road                                   Albinusdreef 2 - Postbus 9600
GB Sutton (Surrey) SM2 5PT                   NL 2300 RC Leiden
United Kingdom                               The Netherlands
Tel: +44 20 86613276                         Tel: +31 71 5263464
Fax: +44 20 86430373                         Fax: +31 71 5266760

O’Dwyer Peter James                          Otten Jacques
Member EORTC Protocol Review Committee       Member EORTC Headquarters - Institutional
University Of Pennsylvania - Presbyterian    Review Board
Medical Center                               Universitair Ziekenhuis Brussel
51 N. 39th Street, Suite 103                 Laarbeeklaan 101
US Philadelphia PA 19104                     BE 1090 Brussels
U.S.A.                                       Belgium
Tel: +1 215 6628636                          Tel: +32 2 4775775
Fax: +1 215 2433269                          Fax: +32 2 4775783        

Oliveira Joao                                Parmar Mahesh
Member EORTC Protocol Review Committee       Member EORTC Protocol Review Committee
I.P.O. Francisco Gentil - Centro De Lisboa   MRC Cancer Trials Office
Clinical Director                            Cancer Division
Rua Prof. Lima Basto                         222 Euston Road
PT 1099-023 Lisboa CODEX                     GB London NW1 DA
Portugal                                     United Kingdom
Tel: +351 21 7229823                         Tel: +44 20 76704731
Fax: +351 21 7229822                         Fax: +44 20 76704818   

Ortiz-Romero Pablo Luis                      Parulekar Wendy
Secretary EORTC Cutaneous Lymphoma Task      Member EORTC Protocol Review Committee
Force                                        Ncic Clinical Trials Group - Queen’S University   5. EORTC Courses y Conferences
Hospital Universitario 12 De Octubre         NCIC Clinical Trials Group
Serv. de Dermatologia                        10 Stuart Street Cordoba, s/n                         CA Kingston ONTARIO K7L 3N6
ES 28041 Madrid                              Canada
Spain                                        Tel: +1 613 5336430
                                                                                                        Director &

Tel: +34 91 3908302                          Fax: +1 613 5332941
Fax: +34 91 3908302                
                                  Patel Poulam                                Piccart Martine
                                  Member EORTC General Assembly               Trial Coordinator (10041)
                                  Chairman EORTC Melanoma Group               Past president EORTC Board
                                  Nottingham City Hospital                    Member EORTC General Assembly
                                  Academic Unit of Clinical Oncology          Institut Jules Bordet
                                  Hucknall Road                               Dept of Chemotherapy
                                  GB Nottingham NG5 1PB                       Rue Heger-Bordet, 1
                                  United Kingdom                              BE 1000 Brussels
                                  Tel: +44 115 8231850                        Belgium
                                  Fax: +44 115 8231849                        Tel: +32 2 5413206
                                       Fax: +32 2 5380858
                                  Paz-Ares Luis
                                  Member EORTC Scientific Audit Committee     Poortmans Philip
                                  Hospital De La Virgen Del Rocio             Secretary EORTC Radiation Oncology Group
                                  Medical Oncology Department                 Member EORTC Quality Assurance Committee
                                  Avenida de Manuel Siurot s/n                Dr. Bernard Verbeeten Instituut
                                  ES 41013 Sevilla                            Dept of Radiotherapy
                                  Spain                                       Brugstraat 10
202                               Tel: +34 95 5013068//2272                   NL 5042 SB Tilburg
                                  Fax: +34 95 4232992                         The Netherlands
                               Tel: +31 13 5947765
                                                                              Fax: +31 13 4685174
                                  Pector Jean Claude                
                                  Member EORTC Headquarters - Institutional
                                  Review Board                                Pritchard K.
                                  Institut Jules Bordet                       Member EORTC Independent Data Monitoring
                                  Dept de Chirurgie                           Committee
                                  Rue Heger-Bordet, 1                         Odette Cancer Centre - Sunnybrook Health
                                  BE 1000 Brussels                            Sciences Centre
                                  Belgium                                     2075 Bayview Avenue
                                  Tel: +32 2 5413159                          CA Toronto ONTARIO M4N 3M5
                                  Fax: +32 2 5413141                          Canada
                                                                              Radtke Susanne
                                  Peters Godefridus                           Member EORTC General Assembly
                                  Member EORTC General Assembly               Ex-Officio Member EORTC Board
                                  Chairman EORTC Pharmacology & Molecular     NCI Liaison Office
6. EORTC Director y Conferences

                                  Mechanisms Group                            Avenue E. Mounier 83 b 12
                                  Member EORTC Translational Research         BE 1200 Brussels
                                  Advisory Committee                          Belgium
                                  Vrije Universiteit Medisch Centrum          Tel: +32 2 7722217
                                  Dept of Medical Oncology                    Fax: +32 2 7704754
         Courses &

                                  P.O. Box 7057 -(De Boelelaan 1117)
                                  NL 1007MB Amsterdam
                                  The Netherlands
                                  Tel: +31 20 4442633
                                  Fax: +31 20 4443844
Raemaekers John                                Ruers Theo
Trial Coordinator (20051)                      Treasurer EORTC Gastrointestinal Tract Cancer
Radboud University Nijmegen Medical Centre     Group
544 Dept of Hematology                         The Netherlands Cancer Institute-Antoni Van
P.O. Box 9101 - Geert Grooteplein 10           Leeuwenhoekziekenhuis
NL 6500 HB Nijmegen                            Head of the Division Surgical Oncology
The Netherlands                                Plesmanlaan 121
Tel: +31 24 3614762                            NL 1066 CX Amsterdam
Fax: +31 24 3542080                            The Netherlands                     Tel: +31 20 5122565
                                               Fax: +31 20 5122554
Ravaud Alain                         
Member EORTC Protocol Review Committee
Hopital St. Andre                              Rutgers Emiel
Onco. Medicale, Serv. de Cancerologie          Trial Coordinator (10041, 10981)
1, rue Jean Burguet                            Secretary General EORTC Board
FR 33075 Bordeaux CEDEX                        Member EORTC General Assembly
France                                         Treasurer EORTC Breast Cancer Group
Tel: +33 556795808                             Secretary General EORTC Executive
Fax: +33 556795896                             Committee
                                                                                               203                   The Netherlands Cancer Institute-Antoni Van
Ring Alistair                                  Plesmanlaan 121
Treasurer EORTC Cancer in Elderly Task Force   NL 1066 CX Amsterdam
Royal Sussex County Hospital                   The Netherlands
Sussex Cancer Centre                           Tel: +31 20 5122551
GB Brighton BN2 5BE                            Fax: +31 20 5122554
United Kingdom                       
Tel: +44 1273 696955 ext 4331
Fax: +44 1273 623312                           Ruyskart Pascal                      Member EORTC Headquarters - Institutional
                                               Review Board
Rosell Rafael                                  EORTC
Member EORTC Protocol Review Committee         Avenue E. Mounier 83, bte 11
Hospital Germans Trias I Pujol                 BE 1200 Brussels
Oncology Research - Catalan Institute of       Belgium
Oncology                                       Tel: +32 2 7741620
Carretera Del Canyet, s/n (Can Ruti)           Fax: +32 2 7723545                              5. EORTC Courses y Conferences
ES 08916 Badalona - (barcelona)      
Tel: +34 93 4978925                            Sanson Marc
Fax: +34 93 4978950                            Treasurer EORTC Brain Tumor Group                             Chu Pitie-Salpetriere (AP-HP)
                                                                                                        Director &

                                               Dept of Neurology
                                               47-83, boulevard de l’Hopital
                                               FR 75651 Paris CEDEX 13
                                               Tel: +33 142160391
                                               Fax: +33 142160375
                                  Sauerwein Wolfgang                            Schmoll Hans Joachim
                                  Trial Coordinator (11001)                     Trial Coordinator (40054)
                                  Universitaetsklinikum - Essen                 Martin Luther Universitaet
                                  Strahlenklinik                                Hematology / Oncology
                                  Hufelandstrasse 55                            Ernst-Grube-Str. 40
                                  DE 45122 Essen                                DE 06120 Halle /SAALE
                                  Germany                                       Germany
                                  Tel: +49 201 7232052                          Tel: +49 345 557-2849/2924
                                  Fax: +49 201 7235908                          Fax: +49 345 557-2950

                                  Scalliet Pierre                               Schoeffski Patrick
                                  Member EORTC Independent Data Monitoring      Trial Coordinator (62052)
                                  Committee                                     Member EORTC General Assembly
                                  Cliniques Universitaires St. Luc              Member EORTC Board
                                  Dept Radiotherapie                            Chairman Clinical Research Division
                                  Avenue Hippocrate, 10                         Member EORTC Executive Committee
                                  BE 1200 Brussels                              U.Z. Gasthuisberg
                                  Belgium                                       Dept of Oncology
204                               Tel: +32 2 7644726                            Herestraat 49
                                  Fax: +32 2 7648948                            BE 3000 Leuven
                                                                                Tel: +32 16 346900 // 6916
                                  Schadendorf Dirk                              Fax: +32 16 346901
                                  Secretary EORTC Melanoma Group      
                                  Universitaetsklinikum - Essen
                                  Klinik fuer Dermatologie                      Scurr Michelle
                                  Hufelandstrasse 55                            Member EORTC New Drug Advisory
                                  DE 45122 Essen                                Committee
                                  Germany                                       Royal Marsden Hospital
                                  Tel: +49 201 7232431                          Fulham Road 203
                                  Fax: +49 201 7235935                          GB London SW3 6JJ
                                          United Kingdom
                                                                                Fax: +44 20 73490701
                                  Schmitt Manfred                     
                                  Member EORTC Translational Research
                                  Advisory Committee                            Seymour Lesley
                                  Technische Universitaet Muenchen - Klinikum   Member EORTC Protocol Review Committee
6. EORTC Director y Conferences

                                  Rechts Der Isar                               Ncic Clinical Trials Group - Queen’S University
                                  Frauenklinik                                  10 Stuart Street
                                  Ismaninger Strasse 22                         CA Kingston ONTARIO K7L 3N6
                                  DE 81675 Muenchen                             Canada
                                  Germany                                       Tel: +1 613 5336430
         Courses &

                                  Tel: +49 89 41402449                          Fax: +1 613 5332411
                                  Fax: +49 89 41407410                
Shepherd Frances                             Smit Egbert F.
Member EORTC General Assembly                Trial Coordinator (08061)
Member EORTC Board                           Vrije Universiteit Medisch Centrum
Chairman EORTC Protocol Review Committee     P.O. Box 7057 -(De Boelelaan 1117)
University Health Network - Oci / Princess   NL 1007MB Amsterdam
Margaret Hospital                            The Netherlands
Medical Oncology Dept                        Tel: +31 20 4444782
610 University Avenue                        Fax: +31 20 4444328
CA Toronto ONTARIO M5G 2M9         
Tel: +1 416 9464522                          Smyth John F.
Fax: +1 416 9466546                          Member EORTC General Assembly                   University of Edinburgh
                                             Assistant Principal, Room G1
Siu Lillian                                  1 George Square
Member EORTC Protocol Review Committee       GB Edinburgh EH8 9JZ
University Health Network - Oci / Princess   United Kingdom
Margaret Hospital                            Tel: +44 1316511694
Dept of Medical Oncology           
610 University Avenue
CA Toronto ONTARIO M5G 2M9                   Sobrero Alberto
Canada                                       Member EORTC Protocol Review Committee
Tel: +1 416 9462911                          Ospedale San Martino / Cliniche Universitarie
Fax: +1 416 9466546                          Convenzionale                        Oncologia Medica
                                             Pzale Rosanna Benzi
Sleijfer Stefan                              IT 16132 Genova
Member EORTC Board                           Italy
Member EORTC General Assembly                Tel: +39 010 5553977 // 78
Ex-Officio Member EORTC New Drug Advisory    Fax: +39 010 5555141
Chairman EORTC Translational Research
Advisory Committee                           Soria Jean-Charles
Erasmus University Medical Center            Member EORTC Board
Dept of Medical Oncology                     Member EORTC General Assembly
Postbus 5201 (Groene Hilledijk 301)          Ex-Officio Member EORTC Translational
NL 3008 AE Rotterdam                         Research Advisory Committee
The Netherlands                              Chairman EORTC New Drug Advisory                5. EORTC Courses y Conferences
Tel: +31 10 7041733                          Committee
Fax: +31 10 4391003                          Institut Gustave Roussy                      Dept of Medicine
                                             39, rue Camille Desmoulins
                                             FR 94805 Villejuif CEDEX
                                                                                                      Director &

                                             Tel: +33 142114301
                                  Sotiriou Christos                                 Stupp Roger
                                  Member EORTC Translational Research               Trial Coordinator (22033, 26071)
                                  Advisory Committee                                Vice President EORTC Board
                                  Institut Jules Bordet                             Member EORTC General Assembly
                                  Head of Functional Genomics & Translational       Centre Hospitalier Universitaire Vaudois
                                  Research Unit                                     Center for Oncology CPO
                                  Rue Heger-Bordet, 1                               rue du Bugnon 46
                                  BE 1000 Brussels                                  CH 1011 Lausanne
                                  Belgium                                           Switzerland
                                  Tel: +32 2 5413457                                Tel: +41 21 3140156
                                  Fax: +32 2 5380858                                Fax: +41 21 3140737 // 3140200

                                  Stenning Sally                                    Suciu Stefan
                                  Member EORTC Independent Data Monitoring          Member EORTC Headquarters - Institutional
                                  Committee                                         Review Board
                                  MRC Cancer Trials Office                          EORTC
                                  222 Euston Road                                   Avenue E. Mounier 83, bte 11
                                  GB London NW1 DA                                  BE 1200 Brussels
206                               United Kingdom                                    Belgium
                                  Tel: +44 20 76704707                              Tel: +32 2 7741605
                                  Fax: +44 20 76704818                              Fax: +32 2 7713810

                                  Sternberg Cora                                    Surmont Veerle
                                  Member EORTC Board                                Secretary EORTC Lung Cancer Group
                                  Member EORTC General Assembly                     Universiteit Gent
                                  San Camillo And Forlanini Hospitals               Department of Respiratory Medicine
                                  Chief, Dpt Medical Oncology - Pav. Cesalpino II   De Pintelaan 185
                                  Circonvallazione Gianicolense, 87                 BE 9000 Gent
                                  IT 00152 Roma                                     Belgium
                                  Tel: +39 06 58704580
                                  Fax: +39 06 6630771                               Sweep Fred
                                                          Member EORTC Board
                                                                                    Member EORTC General Assembly
                                  Stroobants Sigrid                                 Member EORTC Translational Research
                                  Member EORTC General Assembly                     Advisory Committee
6. EORTC Director y Conferences

                                  Chairman EORTC Imaging Group                      Radboud University Nijmegen Medical Centre
                                  Member EORTC Translational Research               Department of Chemical Endocrinology 479
                                  Advisory Committee                                P.O. Box 9101 - Geert Grooteplein 10
                                  Universitair Ziekenhuis Antwerpen                 NL 6500 HB Nijmegen
                                  Nuclear Medicine                                  The Netherlands
         Courses &

                                  Wilrijkstraat 10                                  Tel: +31 24 3614279
                                  BE 2650 Edegem                                    Fax: +31 24 3541484
                                  Tel: +32 3 8213696
Sylvester Richard                            Tempero Margaret
Member EORTC Headquarters - Institutional    Member EORTC Scientific Audit Committee
Review Board                                 UCSF Helen Diller Family Comprehensive
Ex-Officio Member EORTC Independent Data     Cancer Center
Monitoring Committee                         Deputy Director
Ex-Officio Member EORTC Protocol Review      1600 Divisadero Street # B 726
Committee                                    US San Francisco CA 94115
EORTC                                        U.S.A.
Assistant Director                           Tel: +1 415 8853846
Avenue E. Mounier 83, bte 11                 Fax: +1 415 3539636
BE 1200 Brussels                   
Tel: +32 2 7741613                           Tredan Olivier
Fax: +32 2 7713810                           Member EORTC General Assembly                   Centre Leon Berard
                                             Department of Medical Oncology
Tabernero Josep                              28, rue Laennec
Member EORTC New Drug Advisory               FR 69008 Lyon
Committee                                    France
Hospital General Vall D’Hebron               Tel: +33 478782644
Medical Oncology                             Fax: +33 478782716
Pg.Vall d’Hebron, 119-129          
ES 08035 Barcelona
Spain                                        Van Cutsem Eric
Tel: +34 93 4894350                          Trial Coordinator (40052)
Fax: +34 93 2746059                          Member EORTC Board                       Member EORTC General Assembly
                                             U.Z. Gasthuisberg
Tannock Ian F.                               Dept of Internal Medicine
Member EORTC General Assembly                Herestraat 49
Member EORTC Board                           BE 3000 Leuven
Chairman EORTC Scientific Audit Committee    Belgium
University Health Network - Oci / Princess   Tel: +32 16 344225
Margaret Hospital                            Fax: +32 16 344419
Department of Medical Oncology     
610 University Avenue
CA Toronto ONTARIO M5G 2M9                   Van De Velde Cornelis
Canada                                       Trial Coordinator (10981)                 5. EORTC Courses y Conferences
Tel: +1 4169462245                           Member EORTC General Assembly
Fax: +1 4169464563                           Member EORTC Scientific Audit Committee                        Leiden University Medical Centre
                                             Heelkunde-Gebouw 1K6-R 50
                                             Albinusdreef 2 - Postbus 9600
                                                                                                Director &

                                             NL 2300 RC Leiden
                                             The Netherlands
                                             Tel: +31 71 5262309
                                             Fax: +31 71 5266750
                                  van den Bent Martin J.                         van Herpen Carla
                                  Trial Coordinator (26053)                      Member EORTC General Assembly
                                  Member EORTC New Drug Advisory                 Member EORTC Board
                                  Committee                                      Radboud University Nijmegen Medical Centre
                                  Erasmus University Medical Center              Medical Oncology (550)
                                  Postbus 5201 (Groene Hilledijk 301)            P.O. Box 9101 - Geert Grooteplein 10
                                  NL 3008 AE Rotterdam                           NL 6500 HB Nijmegen
                                  The Netherlands                                The Netherlands
                                  Tel: +31 10 7041415                            Tel: +31 24 3614038
                                  Fax: +31 10 7041031                            Fax: +31 24 3540788

                                  van der Graaf Winette                          Van Krieken J.H.J.M.
                                  Trial Coordinator (62072)                      Member EORTC Quality Assurance Committee
                                  Secretary EORTC Soft Tissue and Bone Sarcoma   Radboud University Nijmegen Medical Centre
                                  Group                                          Dept Pathology (437)
                                  Radboud University Nijmegen Medical Centre     P.O. Box 9101 - Geert Grooteplein 10
                                  Medical Oncology 452                           NL 6500 HB Nijmegen
                                  P.O. Box 9101 - Geert Grooteplein 10           The Netherlands
208                               NL 6500 HB Nijmegen                            Tel: +31 24 3614352
                                  The Netherlands                                Fax: +31 24 3540520
                                  Tel: +31 24 3610353                  
                                  Fax: +31 24 3540788
                                             Van Oosterom Allan T.
                                                                                 Ex-Officio Member EORTC Board
                                  Van Der Maazen R.W.M.                          Member EORTC General Assembly
                                  Member EORTC General Assembly                  U.Z. Gasthuisberg
                                  Chairman EORTC Lymphoma Group                  Dept of Oncology
                                  Radboud University Nijmegen Medical Centre     Herestraat 49
                                  Dept of Radiotherapy                           BE 3000 Leuven
                                  P.O. Box 9101 - Geert Grooteplein 10           Belgium
                                  NL 6500 HB Nijmegen                            Tel: +32 16 346900
                                  The Netherlands                                Fax: +32 16 346901
                                  Tel: +31 24 3614515                  
                                  Fax: +31 24 3568350
                                           Van Poppel Hein
                                                                                 Trial Coordinator (22043)
                                  Van Glabbeke Martine                           Treasurer EORTC Genito-Urinary Tract Cancer
6. EORTC Director y Conferences

                                  Ex-Officio Member EORTC Protocol Review        Group
                                  Committee                                      U.Z. Gasthuisberg
                                  EORTC                                          Dept of Urology
                                  Assistant Director                             Herestraat 49
                                  Avenue E. Mounier 83, bte 11                   BE 3000 Leuven
         Courses &

                                  BE 1200 Brussels                               Belgium
                                  Belgium                                        Tel: +32 16 346687
                                  Tel: +32 2 7741625                             Fax: +32 16 346931
                                  Fax: +32 2 7723545                   
Van Tienhoven Geertjan                        Vermeer Maarten
Trial Coordinator (10981, 22051)              Treasurer EORTC Cutaneous Lymphoma Task
Member EORTC General Assembly                 Force
Academisch Medisch Centrum                    Leiden University Medical Centre
Dept of Radiotherapy                          Dept. of Dermatology
Meibergdreef 9                                Albinusdreef 2 - Postbus 9600
NL 1105 AZ Amsterdam                          NL 2300 RC Leiden
The Netherlands                               The Netherlands
Tel: +31 20 5664231                           Tel: +31 71 5262421
Fax: +31 20 6091278                           Fax: +31 71 5248106           

Velikova Galina                               Vermorken Jan Baptist
Member EORTC General Assembly                 Trial Coordinator (24061)
Chairman EORTC Quality of Life Group          Member EORTC Membership Committee
Member EORTC Protocol Review Committee        Universitair Ziekenhuis Antwerpen
St. James’S University Hospital               Dept of Oncology
Cancer Research UK Clinical Centre, Room      Wilrijkstraat 10
SJH.44.L4.104 - Level 04, Bexley Wing         BE 2650 Edegem
Beckett Street                                Belgium
GB Leeds LS9 7TF                              Tel: +32 3 8213954
United Kingdom                                Fax: +32 3 8250564
Tel: +44 113 2067917                
Fax: +44 113 2068474                        Verweij Jaap
                                              Treasurer EORTC Soft Tissue and Bone
Vergote Ignace                                Sarcoma Group
Member EORTC General Assembly                 Erasmus University Medical Center
Treasurer EORTC Gynecological Cancer Group    Dept of Oncology
U.Z. Gasthuisberg                             Postbus 5201 (Groene Hilledijk 301)
Gynecologic Oncology                          NL 3008 AE Rotterdam
Herestraat 49                                 The Netherlands
BE 3000 Leuven                                Tel: +31 10 7041338
Belgium                                       Fax: +31 10 7041003
Tel: +32 16 344636 // 635           
Fax: +32 16 347687              von Frenckell Remy
                                              Ex-Officio Member EORTC Executive         5. EORTC Courses y Conferences
Verheij Marcel                                Committee
Member EORTC Scientific Audit Committee       EORTC
The Netherlands Cancer Institute-Antoni Van   Director Methodology and Operations
Leeuwenhoekziekenhuis                         Avenue E. Mounier 83, bte 11
Radiation Oncology/Division of Cellular       BE 1200 Brussels
                                                                                                 Director &

Biochemistry                                  Belgium
Plesmanlaan 121                               Tel: +32 2 7741016
NL 1066 CX Amsterdam                
The Netherlands
Tel: +31 20 5122120
Fax: +31 20 6691101
                                  Weber Damien C.                                Wick Wolfgang
                                  Trial Coordinator (22042)                      Member EORTC General Assembly
                                  Hopital Cantonal Universitaire De Geneve       Chairman EORTC Brain Tumor Group
                                  Dept. of Radiation Oncology                    UniversitaetsKlinikum Heidelberg - Kopfklinik
                                  Rue Micheli-du-Crest, 24                       Department of Neurooncology
                                  CH 1211 Geneve 14                              Im Neuenheimer Feld 400
                                  Switzerland                                    DE 69120 Heidelberg
                                  Tel: +41 22 3723270                            Germany
                                  Fax: +41 22 3827117                            Tel: +49 6221 567075
                                                  Fax: +49 6221 567554
                                  Wedding Ulrich
                                  Secretary EORTC Cancer in Elderly Task Force   Wildiers Hans P.M.W.
                                  Universitaetsklinikum Jena                     Member EORTC General Assembly
                                  Klin. Innere Medizin II                        Chairman EORTC Cancer in Elderly Task Force
                                  Erlanger Allee 101                             U.Z. Gasthuisberg
                                  DE 07740 Jena                                  Dept of Medical Oncology
                                  Germany                                        Herestraat 49
                                  Tel: +49 3641 9324216                          BE 3000 Leuven
210                               Fax: +49 3641 9324217                          Belgium
                                         Tel: +32 16 346903
                                                                                 Fax: +32 16 346901
                                  Weltens Caroline                     
                                  Member EORTC Protocol Review Committee
                                  U.Z. Gasthuisberg                              Willemze Roel
                                  Dept of Radiotherapy                           Trial Coordinator (06061)
                                  Herestraat 49                                  Leiden University Medical Centre
                                  BE 3000 Leuven                                 Dept of Hematology
                                  Belgium                                        Albinusdreef 2 - Postbus 9600
                                  Tel: +32 16 347600                             NL 2300 RC Leiden
                                  Fax: +32 16 347623                             The Netherlands
                                     Tel: +31 71 5262267
                                                                                 Fax: +31 71 5266755
                                  Whittaker Sean                       
                                  Trial Coordinator (21011)
                                  Guys & St Thomas Hospital                      Wozniak Wojciech
                                  Skin Tumour Unit                               Member EORTC Translational Research Advisory
                                  Lambeth Palace Road                            Committee
6. EORTC Director y Conferences

                                  GB London SE1 7EH                              National Research Institute Of Mother & Child
                                  United Kingdom                                 Dept Oncology Surgery
                                  Tel: +44 20 71886396                           Kasprzaka 17A street
                                  Fax: +44 20 79228138                           PL 01-211 Warsaw
         Courses &

                                                                                 Tel: +48 22 6323964
                                                                                 Fax: +48 22 6329851
Wyns Cindy
Secretary EORTC Quality Assurance Committee
Quality Assurance
Avenue E. Mounier 83, bte 11
BE 1200 Brussels
Tel: +32 2 7741019
Fax: +32 2 7723545

Young Teresa
Treasurer EORTC Quality of Life Group
Mount Vernon Hospital
Lynda Jackson McMillan Centre
Rickmansworth Road
GB Northwood Middlesex HA6 2RN
United Kingdom
Tel: +44 1923 844878
Fax: +44 1923 844172

Zaffaroni Nadia
Member EORTC Translational Research Advisory
Istituto Nazionale Per Lo Studio E La Cura Dei
Division of Oncology
Via Venezian, 1
IT 20133 Milano
Tel: +39 02 23903260
Fax: +39 02 23903052

                                                 5. EORTC Courses y Conferences
                                                 6.       Director &
5.       Courses &
6. EORTC Director y Conferences


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