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					NATIONAL CANCER RESEARCH INSTITUTE
                  (NCRI)
     CLINICAL STUDIES GROUPS



    Bladder     Cancer   -    Brain
    Tumours - Breast Cancer -
    Colorectal Cancer - Consumers
    - Gynaecological Cancer - Head
    and Neck Cancer - Lymphomas
    - Lung Cancer - Melanomas -
    Prostate Cancer - Radiotherapy
    - Renal Cancer - Sarcomas -
    Testis Cancer - Upper Gastro-
    Intestinal Cancer….




       2001 Progress Report
NATIONAL CANCER RESEARCH INSTITUTE CLINICAL
       STUDIES GROUPS SECRETARIAT


• is jointly funded by the Cancer Research Campaign, the
  Imperial Cancer Research Fund, the Leukaemia Research
  Fund and the Medical Research Council,

• receives contributions from Breakthrough Breast Cancer,
  the Institute of Cancer Research, Ludwig Institute of Cancer
  Research, Marie Curie Cancer Care and Tenovus,

• services 14 site-specific 'Clinical Studies Groups'
  developing basic science and clinical trial initiatives,

• established a Consumer Liaison Group (CLG) and a
  Radiotherapy Group in 2000,

• services a Translational Technologies Group (formerly the
  Biomarkers and New Technologies Ad Hoc Groups) advising
  on the current status of new translational technology
  research in clinical cancer research,

• co-ordinates joint funding for a large number of multicentre
  clinical trials,

• plays a major role in facilitating and co-ordinating joint
  initiatives by the Funding Bodies,

• hosts the “Europe Against Cancer” programme in the U.K.

• until recently, administered multi-million pound programmes
  of collaborative research in radiation biology and the
  epidemiology of childhood cancer (the UK Childhood
  Cancer Study).
 NATIONAL CANCER RESEARCH INSTITUTE
                                  (NCRI)
              CLINICAL STUDIES GROUPS




                       Progress Report
                        October 2001



NCRI Clinical Studies Group
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom


Telephone:     020 7269 3548/3249
Fax:           020 7269 3398
E-mail:        ukcccr@icrf.icnet.uk
Website:       http://ukcccr.icnet.uk/
PREFACE
The National Cancer Research Institute and the National Cancer Research Network
This year has seen major changes in the structures that govern and fund cancer research in the United Kingdom. The
success of the Cancer Research Funders Forum in bringing together all major funders of cancer research has lead to
further strengthening and co-ordinating of ties in the creation of the National Cancer Research Institute (NCRI). The main
funders in the UK will now meet regularly to oversee strategy and planned joint initiatives.

In clinical research we have seen the creation of the National Cancer Research Network (NCRN) and the National
Translational Cancer Research Network (NTRAC). The NCRN has been developed to improve the integration, quality and
speed of research focusing on phase III trials and other well designed studies with some involvement in phase II studies.
The Co-ordinating Centre for the National Cancer Research Network has been chosen and is a consortium between the
University of Leeds, the University of York and the Medical Research Council’s Clinical Trials Unit in London. The Centre
will help to organise the provision of research infrastructure rolling out a programme through the 34 cancer networks being
established across England. In addition it has been given a remit to review the functions and relationships of clinical trials
offices by the NCRI and this will include all of those across the UK. The tumour and study groups of the former United
Kingdom Co-ordinating Committee for Cancer Research will now be renamed as National Cancer Research Institute
Groups, and the Secretariat which has looked after them so well for so many years will be incorporated in the Co-
ordinating Centre and remain under the leadership of Miss Julie Hearn. A number of other changes, including some
unification and some streamlining of the trials approval process and specific initiatives in information systems to support
trials data management, are moving forward fairly quickly now.

What will all this mean in the long run? The provision of infrastructure, eventually costing something under £20 million per
year, should make it easier to deliver clinical trials. The strengthening of the Tumour Groups should allow the creation of
a comprehensive portfolio of trials for most cancers through the invention of new trials or the adoption of appropriate trials
from other national and international research organisations. There are many scientific opportunities and many needs for
additional evidence to inform how we organise our health services and we hope this will become an exciting new start for
clinical trials and related clinical research in the United Kingdom.




Professor Peter Selby
NCRN DIRECTOR




This Report provides an overview of the activities of the UKCCCR over the preceding two years, since the last report was
published. Major changes have occurred in the organisation of cancer research in the UK during that period, as Peter has
alluded to above, and I am pleased to have been involved in the smooth transition of the organisation into the NCRI
Clinical Studies Groups. These Groups have developed and flourished over recent years, and have developed a strong
portfolio of cancer clinical trials that aim to answer both scientific and pragmatic questions for the care of patients with
cancer. I wish the Groups every success under the National Cancer Research Institute.




Professor Sir William Asscher
UKCCCR CHAIRMAN 1997-2001
CONTENTS

 1      BACKGROUND
 1.1    Origin
 1.2    Terms of Reference
 1.3    Report on the Main Committee
 1.4    Future Remit
 2      SECRETARIAT
 2.1    Management Team
 2.2    Role of the Secretariat
 2.3    Organisational Chart
 2.4    Secretariat Staffing
 3      REPORTS FROM THE NCRI CLINICAL STUDIES GROUPS
 3.1    Bladder Cancer Group
 3.2    Brain Tumour Group
 3.3    Breast Cancer Subcommittee
 3.4    Colorectal Cancer Group
 3.5    Consumer Liaison Group
 3.6    Gynaecological Cancer Group
 3.7    Head and Neck Cancer Group
 3.8    Lymphoma Group
 3.9    Lung Cancer Group
 3.10   Melanoma Group
 3.11   Prostate Cancer Group
 3.12   Renal Cancer Group
 3.13   Radiotherapy Group
 3.14   Sarcoma Group
 3.15   Testis Cancer Group
 3.16   Upper Gastro-Intestinal Cancer Group
 4      REPORTS ON RESEARCH PROGRAMMES
 4.1    Radiation Research Programme
 4.2    UK Childhood Cancer Study
 4.3    Europe Against Cancer Programme
 5      DISSEMINATION OF INFORMATION
 5.1    Publications
 5.2    Website
 6      FINANCIAL STATEMENT
            REPORT OF THE NCRI CLINICAL STUDIES GROUPS

1. BACKGROUND
1.1 Origin
An Editorial on the position of cancer research in the UK in the Lancet in 1966 concluded "Two steps seem urgently
needed: the Government must provide more money; and closer liaison and co-ordination of effort must be achieved
between the organisations which support cancer research in this country."

Several years later in 1970 the three bodies funding the majority of cancer research: the British Empire Cancer Campaign
(now the Cancer Research Campaign or CRC), the Imperial Cancer Research Fund (ICRF) and the Medical Research
Council (MRC) met for the first time within the formal organisation of the Co-ordinating Committee on Cancer Research
(CCCR), which was renamed the United Kingdom Co-ordinating Committee on Cancer Research in 1984.

In 1999, the 'Guidelines for Membership' were revised, and as a result the CRC, ICRF and MRC were joined by the
Leukaemia Research Fund as a Full Member, and five Associate Members began providing financial support to the
organisation. These were Breakthrough Breast Cancer, the Institute of Cancer Research, Ludwig Institute of Cancer
Research, Marie Curie Cancer Care and Tenovus.

1.2 Terms of Reference
The terms of reference of the UKCCCR until July 2001 were:

•   to provide a forum for the co-ordination of research activities and for the exchange of views and information about the
    policies, portfolios, priorities and plans of the sponsors, taking due account of the activities of the Health Departments
    and other relevant bodies;

•   to recommend to the sponsors proposals for the co-ordination of policies;

•   to advise the sponsors on issues of relevance to the conduct of cancer research and on any other matters which may
    be put to the Committee, and to pass on information to the Health Departments and other relevant bodies as
    appropriate;

•   to facilitate national and international cancer clinical trials and other multi-centre studies in the UK.

1.3 Report on the Main Committee
Over the past two years the Main Committee has been involved in lobbying Government and professional bodies to try to
help secure the future of cancer registration in the UK. The issue of funding for cancer genetics services has continued to
be a major concern, and one that the Main Committee has been in correspondence with the Government with over a
number of years.

At the request of the Main Committee, scientific members of the site-specific Groups have provided input into the National
Institute of Clinical Excellence (NICE) health technology appraisals of cancer agents; in certain cases this has led to major
revisions of the final guidance to the NHS.

Clarification of the mechanisms for the joint funding of trials has been sought with the Full Members, and the Committee is
pleased that streamlining of the trials approval process is being taken forward by the NCRI.

As data collection for the UK Childhood Cancer Study was complete and preliminary analyses were published, the Main
Committee agreed to the transfer of administrative and financial responsibility for the remainder of the study to the
                                  st
Leukaemia Research Fund as of 1 April 2001.
                                                                                      st
The Second UKCCCR Radiation Research Programme was completed on 31 March 2001. Ten laboratory research
projects were conducted under the programme and a Final Report was published in July 2001.

The Chairman’s Advisory Group (CAG) provided a forum in which the Chairman of the UKCCCR could meet with senior
representatives of the Full Members (CRC, ICRF, MRC and LRF) to explore strategic thinking and develop major policy
issues. As such the CAG played a major role in setting the agenda for the forthcoming meetings of the UKCCCR Main
Committee.

With the establishment of the Cancer Research Funders Forum (CRFF) in 1999, and the successful development and
transition of the CRFF into the National Cancer Research Institute (NCRI) in March 2001, the Full Members of the
UKCCCR agreed that the strategic remit of the UKCCCR would thereafter be undertaken by the NCRI.
1.4 Future Remit
                                                                  th
The UKCCCR Main Committee met for the last time on 16 July 2001, with the Chairman and Vice-Chairman standing
down and passing on the responsibility for the Clinical Studies Groups to the NCRN Co-ordinating Centre (an initiative of
the CRFF), the NCRN Steering Group, and ultimately to the NCRI.

The Chairmen of the existing UKCCCR groups have been invited to take over as the Chairs of the NCRI Clinical Studies
Groups in the first instance. Eventually strong representation from the Research Networks of the NCRN will be
appropriate. Each NCRI Clinical Studies Group will have a UK wide remit to:
• be responsible for its trials portfolio;

•    propose new trials and other well-designed studies;

•    consider trials proposed by others;

•    consider international trials for inclusion in the national portfolio;

•    receive inputs
     •   from NTRAC and other early clinical trials groups
     •   from NCRN evidence reviews and economic reviews;

•    submit trial applications for approval;

•    provide tumour specific or task specific advice as required to the NCRN Steering Group or NCRI ;

•    undergo peer review of their overall portfolio 3 yearly.


2. SECRETARIAT
2.1 Management Team
The Management Team, chaired by Dr Angela Galpine since 1998, consisted of representatives of the Full Member
organisations and was responsible for the day-to-day operation of the UKCCCR Secretariat office, approving annual
budgets and statements of financial activities.

The Management Team met for the last time on 12th July 2001 and agreed to hand over responsibility for the Secretariat
to the NCRN Director and to the NCRN Steering Group, on which the organisations are all represented.
2.2 Role of the Secretariat
The role of the NCRI Clinical Studies Groups Secretariat is to:

•   service the Groups to enable them to oversee a portfolio of trials;

•   co-ordinate a rolling programme of peer review in liaison with the NCRN Steering Group;

•   develop transparent processes for the appointment and selection of Chairmen and members, and implement these
    following a pilot period;

•   monitor membership and report to the Steering Group on a regular basis on the need for membership renewal or
    review;

•   identify potential areas for new Groups and report to the Steering Group on the likely implications, both financial and
    scientific, of establishing any new Groups;

•   establish new Groups, as agreed upon by the Steering Group;

•   lead consumer input on Study Groups, Working Parties, and Steering Committees;

•   provide high quality National Clinical Trials Meetings for existing trial collaborators and NCRN staff;

•   maintain a close relationship with NCRN Co-ordinating Centre staff, staff in the Networks, and the NCRI Administrative
    Director and Secretariat staff.

•   receive input from the NCRN Co-ordinating Centre which includes York Centre for Reviews and Dissemination (CRD)
    and Centre for Health Economics (CHE);
•    provide input to the National Translational Cancer Research Network (NTRAC) and other translational research
     groups;

•    liaise with other National and International trials organisations;

•    provide regular scientific reports on the activities of the Groups to the NCRN Director, and NCRI, as required;

•    provide regular financial reports to the NCRN Steering Group.


2.3 Organisational Chart

                                          National Cancer Research Institute
                                                 Chairman: Sir George Radda
                                            Administrative Director: Dr Liam O'Toole


                                                         Steering Group
                                                 Chairman: Professor Peter Selby




National Cancer Research Network
       Director: Professor Peter Selby                           Coordinatin           NCRI Clinical Studies
 Associate Directors: Professor Bob Haward                       g Centre &                  Groups
         and Professor Max Parmar                                 Secretariat        Senior Executive: Ms Julie Hearn
    Assistant Director: Ms Nancy Lester                                                (Funded by the CRC, ICRF,
  (Funded by the Department of Health)                                                       LRF d MRC)



2.4 Secretariat Staffing

                                               NCRN Steering Group Chairman


                                                           NCRN Director
                                                         Professor Peter Selby


                                                           Senior Executive
                                                            Ms Julie Hearn


                                                           Executive Officer
                                                           Mr John Marshall



      Europe Against                  Senior Secretary                      Secretary                Part-Time Secretary
    Cancer Co-ordinator               Vickie Williamson                   Ulla Ventham                      {vacant}
       Janet Marshall
Senior Executive
Julie Hearn            July 2001 - present
Executive Officer
John Marshall          October 2001 - present
Executive Secretary
Julie Hearn (Acting)   August 2000 - July 2001
Dr Peter Twentyman     March 1996 - July 2000
Deputy Executive Secretary
Joanne Bull (Acting)  August 2000 - August 2001
Julie Hearn           July 1998 - July 2000
Senior Secretary/Administrative Officer
Vickie Williamson     September 2001 - present
Joanne Bull           Nov 1997 - August 2001
Secretaries
Ulla Ventham           October 2001-present
Vickie Williamson      July 2001 - Sept 2001
Kathy Wilkinson        February 1997 - May 2000
Part-Time Secretary
Andrea Samuels         Feb 2000 - October 2001
Europe Against Cancer Co-ordinator
Janet Marshall        December 1995 – present
3. REPORTS FROM THE NCRI CLINICAL STUDIES GROUPS
3.1      Bladder Cancer Group




                        Chairman: Dr T Roberts

BC2001, a randomised Phase III study of radio-chemotherapy in muscle-invasive bladder cancer has been developed by
the Group and funded by the CRC. It now has MREC approval and was launched at the British Cancer Research Meeting
                       nd
in Leeds on Monday 2 July 2001. The study has been jointly developed by Dr Nick James (Birmingham) and Dr Robert
Huddart (Royal Marsden Hospital). It uses a 2 x 2 factorial design and randomises between conventional and conformal
radiotherapy, which in turn is given either alone or with concomitant Mitomycin C and infusional 5-fluorouracil.

A sub-group has been established to develop protocols for the treatment of superficial bladder cancer. An initial proposal
is to examine the potential for oral Ciprofloxacin to reduce the recurrence rate of superficial bladder cancer. Oral
Ciprofloxacin is commonly given to patients following transurethral resection of superficial bladder tumours and is known to
be well tolerated. There is in vitro evidence that it is active against transitional cell carcinoma in vitro and it therefore
appears an attractive candidate for testing in this setting.

Members of the Group have collaborated in the development of multi-national collaborative studies with the EORTC and
the GU Global Group. The first of these will compare the efficacy of a combination of Gemcitabine and Cisplatin with a
combination of Taxol, Gemcitabine and Cisplatin in patients with advanced and metastatic transitional cell carcinoma. The
second will examine the effect of adjuvant chemotherapy on survival following cystectomy for muscle-invasive bladder
cancer.

Discussions continue within the Group and with pharmaceutical companies to develop novel regimes for the treatment of
metastatic disease. Trials of these regimes will need to compliment, rather than compete with, studies being carried out by
the EORTC in Europe.
The Chairman of the Group, together with the Chairman of the Prostate Group, participated in the annual face to face
                                                                              rd
meeting of the Global GU Cancer Group at the AUA in Anaheim on Sunday 3 June 2001.

There is considerable enthusiasm within the Group for developing new protocols to improve the outcome for patients with
superficial, muscle-invasive and advanced transitional cell carcinoma. We look forward to working within the new structure
of the NCRN with the enhanced infrastructure support that this organisation promises.

3.2 Brain Tumour Group




                        Chairman: Dr M Brada

The results of the MRC BR05 trial in patients with primary cerebral non-Hodgkin lymphoma have now been published in
Cancer and continue to generate considerable interest and controversy; the study found that CHOP has no clear role in
the postradiotherapy treatment of patients (Mead et al, Cancer 2000 Sep 15;89(6):1359-1370).

The BR11 (EORTC 26951) study of adjuvant PCV chemotherapy in patients with anaplastic oligodendroglioma continues
accrual. BR10 Phase III trial (EORTC 22972) of focal fractionated conformal stereotactic boost has also started although
the accrual is slower than expected both in the UK and Europe.

A neoadjuvant “window of opportunity” Phase II study is continuing to assess the true response rate of Temozolomide in
previously untreated malignant glioma and more than 100 patients have so far been entered. The study is expected to
continue for approximately another year.

The BR12 trial comparing the efficacy of Temozolomide versus PCV chemotherapy in patients with recurrent malignant
glioma has received approval for funding from the CRC. An additional arm has been requested comparing two methods of
administration of Temozolomide through a second randomisation. The planned study will be the first large scale Phase III
trial in recurrent malignant glioma ever performed and will provide information not only on the overall outcome of
unselected group of patients, but will also serve as a benchmark for development of new chemotherapy strategies.

The BR13 trial, testing the role of extent of resection in malignant glioma was approved in principle by the MRC Oncology
Trials Approval Committee but did not receive funding approval from Council. This continues to be developed and refined
and other funding avenues are being explored. The trial would be the first world-wide study assessing the role of the extent
of surgery in patients with primary malignant glioma.

The Brain Tumour Group and Lymphoma Group had a joint meeting and have begun to formulate a joint protocol for the
treatment of primary CNS lymphoma. An outline protocol is expected to be completed by the end of 2001.

A group of clinical and laboratory scientists interested in brain tumour research met under the auspices of ICRF and
formulated a proposal for a brain tumour consortium to foster translational research as an important prerequisite for further
successful development of new brain tumour therapies. It is envisaged that the Brain Tumour Group will play a critical role
in this exciting venture.

3.3 Breast Cancer Group




                       Chairman: Dr J Yarnold

The Standardisation of Radiotherapy (START) Trial of breast cancer radiotherapy fractionation continues to make good
progress, and is expected to achieve its accrual target in 2002, at least 1 year ahead of schedule. The Adjuvant Breast
Cancer (ABC) Trial and the Tamoxifen Prevention (IBIS) Trial are now both in the follow-up phase. The results of the AB01
Trial testing taxanes in patients with metastatic breast cancer were presented at ASCO in May 2001 (the data failed to
demonstrate a substantial benefit for the experimental arm). The final analysis of the DCIS Trial has been undertaken and
will be published shortly. The aTTom Trial, testing the duration of tamoxifen, continues to recruit well.

The IBIS2 Trial testing tamoxifen versus anastrozole versus placebo in post-menopausal women with DCIS or at increased
risk of breast cancer is due to open accrual, setting itself a target of 16000 individuals overall, including 6000 in the DCIS
stratum. At the May meeting of the Group, two trial proposals (TACT and tAnGo) were approved for support by the
UKCCCR, one testing the added benefit of taxanes to an anthracycline schedule in patients with early breast cancer. A
working party has been established to consider other new trial proposals for patients with DCIS, including measures to
improve local control of this disease. Trials in advanced disease and for elderly patients with early disease are also under
active development by members.

With the reconstitution of the UKCCCR Breast Cancer Group as the NCRI Breast Clinical Studies Group, procedures and
working practices are under review. There is recognition that the Study Group needs to encourage more widespread links
with the research community in the development of research proposals. As a result, a survey has recently been distributed
                                                      th
to active trialists in the UK. The programme for the 5 National Cancer Trials Meeting at The Royal College of Physicians
          nd
on the 22 November 2001, will discuss these and other issues.

3.4 Colorectal Cancer Group




                        Chairman: Professor N Williams

The Group continues to consider and develop clinical trials and keeps abreast of basic science developments, which might
translate into the clinical arena. The Medical Research Council Advanced Colorectal Cancer Working Party has now been
successfully absorbed into the NCRI Colorectal Clinical Studies Group, and this has improved the dynamism of the Group.
As a result we have reorganised our modus operandi. We now have six Groups; surgical, adjuvant, advanced disease,
anal cancer, rectal cancer and prevention, each of which acts as a think tank and brings forward to the main group new
ideas for trials. This model is working well and various ideas have been generated which we hope will come to fruition in
due course.
The National Colorectal Cancer Trials Meeting Annual, a joint Meeting between the MRC and the NCRI Clinical
Studies Groups, will be held in Oxford in September under the banner of the NCRI Clinical Studies Groups. The
aim is to review all colorectal trials either planned or ongoing in the UK and also to update delegates on key
trials elsewhere. This meeting is now regarded as the premier meeting on the subject in the UK. It also
provides a focus for active trialists to compare notes.

The AXIS Trial (intraportal infusion study) has closed, and two papers dealing with the trial results and the
pathological data have been submitted to the Lancet simultaneously. The certain arm of the QUASAR Study
has now been published in the Lancet (Gray et al, 2000;355, 9215:1588-1596). The uncertain arm continues as
QUASAR 1 and should reach its target recruitment of 2,500 patients later this year. A paper on quality of life
issues in relation to this trial is also in preparation.

New adjuvant trials are being designed to investigate the effects of the new oral 5FU prodrug Capecitabine, and
the novel active topoisomerase I inhibitor Irinotecan in colon cancer.

A new anal cancer trial (ACT II) was launched in March 2001, which investigates the addition of Cisplatin to
standard treatment regimes.

The NCRI Colorectal Clinical Studies Group takes a keen interest in those trials developed by the MRC Clinical
Trials Unit and receives regular reports on their progress. CRO5 has now closed for recruitment. CR07 has
been launched and recruitment is improving, despite an initial sluggish phase. CR08 has been launched, and by
March 2001 387 patients had been recruited.

Future trials under consideration by the Group include the use of intraperitoneal infusion of chemotherapeutic
agents in T3 and T4 tumours. A trial to study the need and extent of follow-up for patients who have undergone
resection for colorectal cancer has been turned down for funding by the NHS R&D. However, another group
were funded for a similar concept. Despite this disappointment, it is the Group’s intention to see if we can
combine forces with the “rival” group to produce a national trial to address the question of the optimal methods
for patient follow-up in a timely manner.

Finally, the Group have debated the new changes proposed for the NCRN and the NCRI, and are
wholeheartedly in support of this new development. Members look forward to the incorporation of the Group
into the new arrangements, and believe strongly that the changes will benefit both patients and the academic
community who are engaged in clinical trials.

3.5 Consumer Liaison Group




                    Chairman: Mr D Stewart
The Consumer Liaison Group (CLG) continues to develop a creative and innovative approach to its given
Terms of Reference. The following quote illustrates the core element of partnership that invites reflection on
user involvement, consultation and collaboration:

I have never in all these years thought of the matter in quite this way; but then it is perhaps in the
nature of coming on a trip such as this that one is prompted towards such surprising new perspectives
on topics one imagined one had long ago thought through thoroughly.
from Ishiguro’s novel The Remains of the Day

Since the CLG met for the first time in June 2000 members have been involved in the following:

    •   The Department of Health Selection Panel for the NCRN Co-ordinating Centre
    •   CRC, MRC and IRCF Joint Samples Collection Working Group
    •   START Breast Cancer Radiotherapy Trial Steering Committee
    •   UKCTOCS Ovarian Cancer Screening Study Trial Steering Committee
    •   Videos for Training Health Professionals in Communication Skills
    •   Workshop facilitation at the 2001 Global Cancer Conference
    •   The Joint Sample Collection Working Party
    •   The MRC Oncology Trials Advisory Committee
    •   A number of CLG members have also provided feedback on patient information sheets for trials in
        development.

Members of the CLG are now sitting on 9 of the 14 NCRI Clinical Studies Groups. We are in the process of
asking support organisations to nominate members to sit on the central CLG and the remaining Cancer
Groups. CLG members have reported back in an extremely positive way to the manner in which they were
received by these Groups.
The CLG was pleased at the offer of two places for the Chair and Vice-Chair on the UKCCCR Main Committee,
reflecting a true understanding of cancer patient needs. We are additionally pleased to have worked with the
numerous professionals who have accepted our unique cancer journeys as valid and contributory experiences.

The CLG is keen to approach the future in the same way that it has addressed matters in its first year; through
partnership and consultation. We will be taking an active role in establishing a broader scope for user
involvement within the new cancer research structures through participation in a series of forthcoming ‘think
tank’ meetings with Professor Peter Selby.

3.6 Gynaecological Cancer Group




                      Chairman: Professor D Luesley
Another successful multigroup National Meeting, incorporating UKCCCR, MRC, BGCS and the EORTC, was
held on 6th April 2001 at the Royal College of Physicians, and was attended by over 300 delegates. It provided
an excellent platform for development of our national network and further collaboration with the EORTC.

The Group’s membership has not changed radically although we have invited two medical and one clinical
oncologist to join the Group in order to facilitate our capacity to develop trials and give rapid advice on new
cytotoxic agents to other groups and institutions. To this end the Group has just provided advice to NICE on
topotecan and is currently preparing advice on liposomal doxorubicin.

We have further developed relationships with other trials groups and in particular with the GOG (Gynaecology
Oncology Group). It is likely that some of the centres that recruited so well to the recently completed ICON 3
trial will want to recruit to GOG 182 either through the MRC Clinical Trials Unit or by direct affiliation with the
GOG.

The UKCTOCS trial of ovarian cancer screening has commenced recruitment and three centres are now
actively entering patients. Twelve centres are planned in all. The UK Familial Ovarian Cancer Screening Study
(UK FOCS) has now received funding from the CRC and was launched at the British Society for Human
Genetics meeting in May 2001.

A subgroup that has been working toward new studies in cervical cancer and has asked for a full protocol to be
prepared for a phase II study of relapsed cervical cancer. We are still in the process of deciding what, if any,
trials utilising chemoradiation we should consider for UK patients; a phase III trial is under development.

Potential trials in uterine sarcoma have been discussed in collaboration with the Sarcoma Clinical Studies
Group. Two potential trials in vulval cancer are under development.

The Group continues to support and contribute to trials developed by the MRC Clinical Trials Unit. The MRC
ASTEC investigating lymphadenectomy in women thought to have early endometrial cancer continues to recruit
well; ICON 4, a trial of paclitaxel in relapsed ovarian cancer is recruiting at 13 cases per month and should
complete accrual within 18 months. OV05, a trial designed to determine the benefit of early chemotherapy for
recurrent ovarian cancer, also continues to recruit to target and should complete in October 2002. Recruitment
to OV06, a trial of neoadjuvant chemotherapy and interval debulking surgery in advance stage ovarian cancer,
had been very slow. A revised protocol has been produced by the Steering Group for a much simpler study that
compares immediate surgery followed by chemotherapy with delayed surgery (three courses of chemotherapy
prior to surgery). There are some similarities with the ongoing EORTC study but the EORTC study still retains
IDS as an option in one of its arms. The NCRI Gynaecological Clinical Studies Group feel that neodjuvant
chemotherapy is the most contemporaneous issue and any new trial should be designed to address this issue.
3.7 Head and Neck Cancer Group




                      Chairman: Dr N Slevin
An overview of the UKHAN study (971 patients) was presented to members at the last meeting with the
conclusion that synchronous chemotherapy given with radiotherapy should be considered the standard non-
surgical management of patients with locally advanced head and neck cancer. The main regime used in the
study was methotrexate. A study of synchronous cisplatin with accelerated radiotherapy is currently being
considered by CRC (versus the hypoxic radiosensitiser, Nimorazole). Members of the Group are also
collaborating in a phase 1 study of oral Capecitabine in this synchronous context.

Synchronous chemotherapy will undoubtedly lead to greater normal tissue morbidity than with radiotherapy
alone. Amifostine is a radioprotector with purported selective protection of normal tissues with the potential for
ameliorating xerostomia, mucositis and cisplatinum toxicities. A double-blind study of Amifostine in nasopharynx
cancer has been awarded funding by the CRC.

The MRC CHARTWEL study (accelerated radiotherapy over 2 1/2 weeks) for postoperative cases commenced
in 2001. This regime potentially offers not only a therapeutic gain but also benefits in patient acceptability and
convenience (2 1/2 weeks versus the standard 6 - 6 1/2 weeks). The Group were very supportive of a further
accelerated protocol being used at Mount Vernon Hospital of accelerated radiotherapy, carbogen and
nicotinamole (ARCON) in T2-T4 larynx cancer. A study of ARCON is being funded by the CRC.

There is a continued effort to try and establish neck node trials to explore conservative surgical approaches
compared against the traditional radical neck dissection either in terms of a selective (morbidity-sparing)
dissection or sentinel node biopsy strategy. A proposed EORTC study of post operative neck nodes with
unknown primary, comparing wide mucosal field radiotherapy versus ipsilateral neck treatment, is also being
considered.

National registration audits continue to document cases of T1 Glottic cancer treated either by laser or
radiotherapy. The laser study is being co-ordinated in Newcastle; the 3-dose radiotherapy has centralised voice
quality analysis in Manchester.

Possible biomarkers in head and neck cancer have been discussed in detail, and the potential for translational
studies to be included in new trials is under constant review.

3.8 Lymphoma Group




                      Chairman: Professor D Linch

The Lymphoma Group has been active in both Hodgkin’s disease and Non-Hodgkin’s lymphoma.

In Hodgkin’s disease, there has been active support for two trials established by the previous UK Lymphoma
Group, namely LY07 and LY09. Both trials are supported by the Cancer Research Campaign. LY07 is a
randomised comparison of mantle field radiotherapy versus a one month course of VAPEC-B chemotherapy
plus involved field (IF) radiotherapy (RT). Recruitment to this trial is slowing as there is a desire to effect a
higher initial cure rate with combined modality therapy and an increasing concern over the long-term effects of
wide-field irradiation. A decision was therefore made in June 2001 to close this trial and move on to a
comparison of VAPEC-B plus IF RT versus an alternative combined modality approach such as ABVD x 4 plus
IF RT. The details of this trial will be worked out by a specific working party over the next few months.
LY09 is a comparison of ABVD versus seven or eight drug regimens in advanced Hodgkin’s disease. The
required accrual of 800 patients will be met in September 2001 and this trial will then close. A randomised
Phase III trial has also been performed under the aegis of the BNLI of the Stanford V regimen versus ABVD +
RT in advanced Hodgkin’s disease and having demonstrated its feasibility, it is proposed to roll this into a
national Phase III trial to replace LY09. This trial will be restricted to patients with 0-3 poor prognostic features,
which represent over 80% of patients with advanced disease. Funding is being sought for a RT quality
assurance scheme to be incorporated into this trial. For the relatively few patients with greater than 3 poor
prognostic factors advanced Hodgkin’s disease, discussions are underway about joining with the EORTC,
GELA and Nordic Lymphoma Groups to compare ABVD with escalated BEACOPP.

In elderly Hodgkin’s disease patients in whom intensive chemotherapy may not be appropriate, Professor
Stephen Proctor in Newcastle is taking the UK lead in the development of a multi-national study.
There is increasing awareness of the very high risk of breast cancer in adolescents and younger females who
have received mantle (axillary) radiotherapy. There was unanimous agreement that such patients should be
identified and informed of the risks. A working party chaired by Professor Alan Horwich and Professor Anthony
Swerdlow is being set up to advise on what advice should be given and what investigative observational studies
should be carried out on these patients.

In the Non-Hodgkin’s Lymphomas (NHL) the international LY03 trial was for patients with newly diagnosed
MALT lymphomas of the stomach. This closed in 2000 with 191 patients registered through the UK office,
because of the unexpectedly very low event rate in the non-intervention arm (other than anti-Helicobacter Pylori
therapy).

Despite this early closure, this is the largest study in this disease and is providing important data on natural
history, restaging pathology and molecular monitoring of this disease. Several papers are in preparation. In
follicular lymphomas the possibility of a randomised trial assessing the role of non-myeloablative allogeneic
transplantation was addressed by the Lymphoma Group. After due consideration and additional expert advice it
was felt premature to initiate such a trial and further protocol optimisation in Phase II trials was first required.
The Lymphoma Group also discussed the role of Mabthera in follicular lymphomas and these discussions
informed the submissions to NICE made by members of the Group.

In Burkitt’s Lymphoma, Dr Ben Mead in Southampton has been instrumental in developing a successor to the
successful LY06 trial. This non-randomised trial will determine the response and survival from a modified (and
hopefully less toxic) CODOXM/IVAC regimen and will permit important pathological studies to be conducted by
Dr Andrew Jack in Leeds. Funding has been obtained from the CRC. The LY02 trial in which the value of a
BEAM autograft after 3 cycles of CHOP is explored in younger patients with poor prognosis histologically
aggressive NHL now has over 450 patients randomised and closes this summer. It will be replaced by the
MISTRAL study in which 8 cycles of CHOP are compared with a sequential high dose therapy regimen as
developed by Gianni in Milan. This is collaboration with the Swiss Lymphoma Group (SAKK) and will address
an important “proof of principle.” This trial is funded in part by the CRC. A study will be conducted in parallel by
Andrew Jack and Gareth Morgan, to assess cellular and molecular prognostic factors. Initial funding for this
was obtained from the LRF. Consideration has also been given to trials in mantle cell lymphoma the lead for
this being taken by Dr Simon Rule in Plymouth. Both clinical and pathological protocols have been developed
and final decisions will depend on availability of Mabthera and whether or not a funded European Collaborative
trial is developed quickly.

3.9 Lung Cancer Group




                      Chairman: Professor I Smith

The Lung Group has had a successful restart, with several important new trials approved or in advanced stages
of planning.

LUCAS Trial
At the time of preparing this report the Group has just heard that the MRC Board (OTAC) had approved our CT
Scan Lung Cancer Screening Trial (LUCAS) with an A/alpha rating. This is excellent news and a credit to the
hard work of Professor Janet Husband and her Working Party. A final decision regarding funding for the trial
has been deferred by Council until December 2001.

Ongoing Trials
The MRC LU21 Trial of dose intensive chemotherapy for small cell lung cancer has almost completed accrual.
LU22 trial of pre-operative chemotherapy continues to accrue but slowly; we are optimistic that accrual will
increase with the inclusion of two Dutch trial groups.

Research and Development - Trials
The Mesothelioma Trial (MESO 1) is currently being reviewed by the CRC Clinical Trials Committee. Although
funding for the trial was turned down by MRC Council in July, the Group remains very enthusiastic about this
trial, the first ever Phase III mesothelioma trial in the UK. An adjuvant trial of biological therapy using IRESSA
and a Cox - 2 inhibitor post-operatively in non-small cell lung cancer was presented by Dr O’Byrne to the Group
and was well-supported, with the proviso that data from Phase I, II and III trials currently running or planned
prove positive.
Professor Jessica Corner presented a project entitled “A Study of the Symptom Complexes Associated with
Early and Late Stage Breast Cancer, and the factors associated with delay in presentation and diagnosis of
Lung Cancer” which has been submitted for funding to the Department of Health Research and Development.
The Group supported this trial, which has since been shortlisted for funding.

Biological Research
Professor Rabbitts described a recent successful teleconference on serum tumour-DNA and other appropriate
markers that might be predictive for response treatment. Dr Tim Ward is planning a Workshop in conjunction
with Professor Rabbitts in Manchester in the Autumn to plan specific research initiatives.

Other Issues
The Group remains concerned at the failure of CHART (Continuous Hyper-Fractionated Radio-therapy) to be
implemented in any significant way across the UK, despite a clearly demonstrated survival benefit in a key
randomised controlled trial funded by the MRC. Dr Fergus Macbeth (Chairman of the CHART Implementation
Group) and myself have written to Professor Mike Richards asking for support in trying to implement CHART at
least on a regional basis.
                                    nd
Finally, the Group is planning the 2 National Lung Cancer Trials Meeting to be held at the Royal College of
                                    th
Physicians in London on January 17 2002.

3.10 Melanoma Group




                     Chairman: Dr M Gore

We have had considerable success this year with the completion of the AIM HIGH adjuvant interferon trial. This
was one of the largest adjuvant trials to be completed and was selected as an oral presentation by Professor
Barry Hancock at the American Society of Clinical Oncology's Annual Meeting which was held in San Francisco
in May of this year. In addition, the meta-analysis that was performed by Dr Keith Wheatley, the Group's
epidemiologist, was also presented at this meeting. The data generated by the AIM HIGH study has made a
major contribution towards assessing the role of interferon in this setting. The Group has adopted the new
EORTC trial of pegylated interferon versus observation only as the recommended study for patients with loco-
regional lymph node involvement that has been resected and accrual in to this trial commenced on mainland
Europe in July 2000 and in the UK in November 2000. The UK has already become the largest accruer of
patients into this study. For patients with primary disease of greater than 1.5mm thickness we are adopting the
EORTC trial of the GMK gangliocide vaccine versus observation as our national study. It is hoped that accrual
will commence during 2001.

The UK Melanoma Study Group/British Association of Plastic Surgeons, Excision Margin Trial has now
completed accrual and preliminary results are expected in late 2001. Two new trials are in an advanced state
of development: the randomised trial of completion lymph node dissection following positive sentinel node
biopsy and the randomised trial of Dacarbazine with or without vaccination with M.Vaccae in patients with
metastatic disease. The former study has been submitted as a feasibility trial to an MREC and the protocol for
the latter has been submitted to the CRC for funding. A trial involving radiotherapy after lymph node dissection
has gained support from the committee, a protocol is being developed and contacts are being made with
melanoma groups in the US and Australia to see whether international collaboration would be feasible.

3.11 Prostate Cancer Group




                      Chairman: Dr D Dearnaley

It has been an eventful year for UK prostate cancer research. The Cancer Research Funders’ Forum
established two collaboratives, or Centres of Excellence, for prostate cancer research. One includes teams in
Newcastle, Sheffield and Manchester (Lead; Professor D Neal), the other the Institute of Cancer Research,
Liverpool and Brunel Universities (Lead; Professor C Cooper). These will act as a focus for laboratory and
translational research with a resource to initiate “start-up” projects nationally. A rapidly responsive peer review
process will be established and annual research meetings organised. Major projects will include the randomised
trial of treatment intervention in localised disease (Northern Group) and the molecular genetic characterisation
of prostate cancer (Institute of Cancer Research).

Of the current national prostate trials, MRC RT01 will successfully complete recruitment of over 800 men this
year. The Institute of Cancer Research’s randomised pilot study, reported at the British Cancer Research
Meeting in Leeds in July 2001, has shown clear evidence for dose/volume effects and a strong suggestion of
improved PSA control of disease with higher (74Gy) radiation dose. MRC Trial PR07 of hormone therapy plus
radical radiotherapy versus hormone therapy alone in non-metastatic disease continues to recruit.

The results of MRC PR05, reported at the ASCO and BCRM meetings in 2001, have strongly suggested an
improvement in symptomatic progression free survival using Clodronate in metastatic disease, with a reduction
of PSA levels and possibility of improved overall survival. Confirmatory trials were required. MRC PR04 will
report in two years’ time and discussions are underway with EORTC to establish a second trial as soon as
possible but using Ibandronate (Roche Pharmaceuticals) as adjuvant to standard treatment in advanced
localised prostate cancer.

A variety of other new studies are to commence or are under development. The CRC has approved a joint trial
with NCI Canada and SWOG of intermittent hormone therapy in men with PSA failure after radical radiotherapy
with or without preceding prostatectomy. Recruitment has begun into the pilot trial of screening for familial
disease in the CRC supported Institute of Cancer Research. The CRC are also funding a study on
cardiovascular and bone changes associated with androgen suppression (Cardiff Group). A proposal for a
multi-arm randomised Phase II/III trial of novel agents in addition to standard androgen suppression for men
with metastatic disease has been submitted to the MRC.

These and further trial initiatives will be taken forward by sub-groups of the NCRI Prostate Clinical Studies
Group which have been established for: (1) localised disease, (2) metastatic/recurrent disease, (3) cardio-
vascular and bone morbidity and (4) gene and novel therapies, (5) novel therapies. The climate for prostate
cancer research in the UK has changed considerably over the last five years and the Group looks forward to
new challenges and opportunities in the NCRI/NCRN structure.

3.12 Radiotherapy Group




                     Chairman: Dr P Hoskin
The Radiotherapy Group was established in December 2000 to address specific issues relating to clinical
research in radiation therapy. It aims to provide a resource for other NCRI Clinical Studies Groups who are
developing new protocols that include radiotherapy. We are also establishing links with the EORTC Radio-
therapy Group seeking to function with them as part of a larger intergroup network for trials addressing specific
radiotherapy questions.

Four specific areas of activity have been identified for development by the Group. The first is that of quality
assurance in radiotherapy within trials in the United Kingdom. Currently this is very limited and patchy and a
clear need has been identified within current protocols being developed by NCRI Clinical Studies Groups for a
core research-based quality assurance group to support this activity. It is anticipated that the establishment of
the National Cancer Research Institute and National Cancer Research Networks will facilitate this development
alongside specific trial-based grant proposals.

Normal tissue damage after radiation therapy is an important area of research and the Group has proposed that
a national network is established to identify patients having extreme normal tissue reactions from whom tissue
can be obtained. This would be stored as a future resource for groups seeking to identify specific markers for
radiosensitivity with particular genomic and proteomic analysis in mind.

Recent developments in radiotherapy have resulted in a large area of new technology becoming available to
clinical practice with the application of conformal and more recently intensity modulated radiation therapy. The
Group is seeking to embrace this in formal clinical trials to evaluate carefully its impact upon treatment
outcomes. In conjunction with the Prostate Group it is involved in the follow on pilot study from the RT01 trial
evaluating dose escalation with conformal radiotherapy in prostrate cancer. It is also supporting a new protocol
for the development of conformal radiotherapy in head and cancer.

A final proposal related to the use of radiotherapy for metastatic bone pain in a new national multicentre trial,
evaluating radiation therapy against the use of bisphosphonates, is currently under discussion with the
pharmaceutical industry.

The Group anticipates close collaboration with the other Clinical Studies Groups in the future as new protocols
including radiotherapy evolve, with a particular focus on the quality assurance aspects of radiation delivery and
the expanding role of chemoradiation.

3.13 Renal Cancer Group




                     Chairman: Professor B Hancock

Renal cancer is uncommon but, once metastatic, notoriously unresponsive to chemotherapy and radiotherapy.
New strategies for adjuvant therapy (following radical surgery), and for advanced disease need to be evaluated
in clinical trials. The NCRI Renal Clinical Studies Group is pleased to take on the supervision of two
randomised clinical trials developed by the former MRC Renal Cancer Planning Group. The first is a
EORTC/CRC study evaluating the role of adjuvant interleukin-2, interferon-alpha and fluorouracil for patients
with high risk of relapse after surgical resection, compared with a control group not having adjuvant treatment.
The second study, funded by the MRC, is in advanced disease. Interferon-alpha (shown in a previous MRC
study to significantly improve overall survival compared with medroxy-progesterone) is to be compared with
interleukin-2/interferon and fluorouracil. This study is now recruiting.

The Renal Group is also advising on and catalysing credible pharmaceutical industry supported Phase II
studies in advanced disease. A major role of the Group is the collation and dissemination of information. Many
patients eligible for clinical trials are not offered the opportunity to participate in these; the Group hopes to
establish why this is so by direct enquiry of those surgeons and oncologists involved in treating these patients.
We have recently collaborated with other professional groups (BAUS, MRC, EORTC) in holding well attended
and successful National meetings where the importance of clinical trials has been given high profile. A further
meeting on Urological Cancer Trials is being planned for Spring 2002, incorporating a symposium on
‘prognostic factors and biological markers’.
3.14 Sarcoma Group




                      Chairman: Dr I Judson
                                                                           th
A final meeting of the UKCCCR Sarcoma Group was held on June 19 2001 prior to the functions of UKCCCR
being taken over by the NCRI. The implications of this change were discussed, including the suggestion that
EORTC protocols might be “adopted” by the Group, provided they are scored satisfactorily by the NCRI
Protocol Review Committee, once that has been set up. This possibility was welcomed but clarification needs to
be sought regarding indemnity and funding issues. New UK studies were also discussed.

A feasibility study for a trial to evaluate immediate versus deferred chemotherapy for patients with
asymptomatic advanced or metastatic soft tissue sarcoma has been developed by the Group and will be run by
the MRC Clinical Trials Unit.

Guidelines for patient referral and care delivery have been agreed within the Group. Implementation will take
place through the new cancer networks but dissemination of these guidelines nationally requires co-ordination.
The Cancer Director, Professor Richards will be approached concerning this, as will the Royal Colleges.
Agreement is close to being reached on a national cancer patient minimum data set. It seems that relatively
little needs to be added to that in order to have a comprehensive national sarcoma database. The Group’s
representative, Rob Grimer, will report back to the NHS Information Authority.

A subgroup met recently to discuss new studies for bone sarcomas, especially osteosarcoma. It is clear that
international collaboration both within Europe and preferably also with groups in the USA is needed in order to
be able to carry out the necessary studies in a reasonable period of time. A consensus was reached that the
current 2-drug regimen of cisplatin and doxorubicin should not be regarded as standard treatment. The results
of treatment in the UK are inferior to those achieved in Italy and the US. There is a significant possibility that this
is due to suboptimal intensity of chemotherapy and a failure to use other active agents such as methotrexate
and ifosfamide. Whether or not a new study addresses the issue raised by the recent US COG trial that
suggests that the immune adjuvant MTP-PE might be beneficial, a new study to replace BO06 will be required
soon that takes these concerns into account. If early initiation of a randomised trial cannot be achieved it was
felt that the standard arm of the recent Children’s Oncology Group study, i.e. cisplatin/doxorubicin/
methotrexate, should be piloted since it would likely be one of the arms used for comparison in a future study.

In addition to osteosarcoma there is a need for ongoing studies in spindle cell sarcomas of bone. The extreme
rarity of these cases precludes a randomised trial design. One suggestion is that the UK Group joins forces with
the German COSS Group, Italian Rizzoli Institute and Scandinavian Sarcoma Group in a proposed multidrug
study for all non-osteosarcoma bone tumours plus osteos in the over 40 age group. There are concerns about
the duration of treatment and complexity of the trial that require discussion. This suggestion received broad
support.

Discussions continue for a new study of adjuvant radiotherapy in soft tissue sarcoma. It has been suggested a
study focused on decreasing morbidity while maintaining tumour control might be feasible. This would take the
form of comparing a standard wide field with smaller central boost approach versus a smaller field – both to the
same total dose. Interest in this study design will be ascertained and an outline proposal submitted to the CRC
for funding.

The treatment of gynaecological sarcomas has been discussed (please see report from the Gyneacological
Group).

Studies that have been funded by members of the NCRI will be discussed in the forum of a large national
meeting in order to disseminate the information and facilitate involvement. It was also suggested that this
meeting should incorporate a surgical treatment workshop.

It was noted that we must address the need for consumer liaison, i.e. a patient representative on the Group.
Other Groups have found this to be helpful. A number of possible ways of identifying a suitable person were
discussed and will be pursued.
3.15 Testis Cancer Group




                      Chairman: Professor S Kaye

PET scanning
This CRC-funded study in Stage 1 teratoma should open this year, possibly in collaboration with Scandinavian
colleagues. A parallel study in seminoma is also being considered. PET scanning has real potential in testicular
cancer to affect management by improving the accuracy of staging.

The contralateral testis
While biopsy of the contralateral testis forms part of current guidelines for those individuals at risk of a potential
second tumour, it is in practice rarely performed. One possible approach would be to conduct the procedure at
the time of initial surgery, and a study along these lines is being prepared by the Group’s surgical specialist -
Professor David Kirk. In addition, he and Professor Oliver will develop further a proposal to explore testis
conservation surgery.

Randomised clinical trials
Progress in initiating new trials has been disappointing, and this reflects the fact that in the majority of patients
with metastatic disease a standard of care (3 cycles of BEP) has been reached. While bleomycin pulmonary
toxicity is an occasional severe problem, it has not yet been possible to develop a randomised trial to pursue
this further. Patients with more advanced disease should soon be entering an EORTC/MRC trial examining the
role of paclitaxel.

For earlier (Stage 1) disease, the key issue in seminoma is whether a single dose of carboplatin proves to be
equivalent to abdominal radiotherapy, and first results from the now-completed MRC randomised trial will
hopefully be available within two years.

Other MRC trials, examining CT scan frequency and assessing the TIP regime in relapsed disease, continue to
recruit steadily.

The Group will be joining up with the other urological cancer Groups to host a National Urological Cancer Trials
Meeting in Spring 2002.



3.16 Upper GI Cancer Group




                      Chairman: Mr J Bancewicz
                                                                                                                    th
The Group had a highly successful annual meeting at the Royal College of Physicians in London on 25
January 2001 and a further meeting is planned for June 2002. Nearly 250 delegates attended and there was
continuing strong support for clinical trials. There was also some frustration at the length of time that it takes to
get new trials up and running. The successor trial to OE02, the very successful preoperative chemotherapy trial
for cancer of the oesophagus, was rejected for funding by the MRC. The CRC has invited a revised version of
the protocol to be submitted as a full proposal.

The CRC have agreed to support a multicentre phase III trial comparing gemcitabine alone or in combination
for the treatment of advanced pancreatic cancer (GEM-CAP). Recruitment to the MRC MAGIC trial of
preoperative ECF chemotherapy for gastric cancer also continues steadily, but slowly in view of the reduced
incidence of this disease. Nearly 450 of the planned 500 patients have been entered to date.
Two protocols are at an advanced stage of development. A phase III randomised trial of somatostatin analogue
therapy and chemo-embolisation for unresectable hepato-cellular carcinoma has received wide support from
clinicians treating this disease. PACIFIC, a trial of proton pump and COX-2 inhibition for cancer prevention in
Barret’s oesophagus has also kindled the interest of the GI community. We think that it is a particularly timely
trial in view of the increasingly high incidence of adenocarcinoma of the oesophagus in the UK. An outline
protocol has been submitted to the MRC.
4. REPORTS ON RESEARCH PROGRAMMES
4.1 Radiation Research Programme
(Chairman: Professor D Goodhead)
The Second Radiation Research Programme was initiated on 1 April 1997 and ran for three years with support
from the nuclear industry. A total of six grants were awarded during 1997 under the Second Programme to a
total cost of £570,000. A further four grants each running for two years and totalling £210,000 were awarded in
June 1998. The Second Programme completed in January 2001 and a Final Report was published in July 2001.

4.2 UK Childhood Cancer Study
(Chairman: Sir Richard Doll)
The UK Childhood Cancer Study (UKCCS) is investigating five hypotheses for the aetiology of childhood cancer
via a national case control study. Identification of cases and two matched controls for each was carried out over
the period 1990-1996, with data collection continuing until 30 June 1998. A high proportion of all cases of
childhood cancers occurring in the UK during that period are included in the Study. The Leukaemia Research
Fund have kindly assumed financial and administrative responsibility for the completion of the Study on behalf
of the UKCCCR from 1 April 2001. The UKCCS Management Committee will continue to be responsible for the
study publications, data and biological material, and will ensure that the study is completed within an agreed
timetable.

4.3 Europe Against Cancer
(Chairman: Professor A Davies)
Since the Steering Committee was set up in 1987 it has played a major role in co-ordinating the provision of
information and educational aspects of the Europe Against Cancer programme throughout the UK. The
Steering Committee reviews proposals submitted annually by the UK for European funding, and makes its
recommendations to the Department of Health. A sub-committee evaluates applications, and awards grants, for
funds allocated by the Department for projects relating to the topic of the annual Europe Against Cancer Week
public awareness campaign. The UK Co-ordinator of the Programme is located within the NCRI Clinical
Studies Groups Secretariat.

In the year 2000, the theme of EAC Week was "Nutrition" and focused on 5-10 year olds; in 2001 the theme is
"Women and Tobacco" and will target women in the 20-35 age range in manual socio-economic groups.




                                                                             th   th
Two of the four posters that will be used for the Europe Against Cancer Week, 8 -14 October 2001.
5. DISSEMINATION OF INFORMATION
An important task for any organisation concerned with research is the dissemination of information regarding its
activities. The NCRI Clinical Studies Groups are actively involved in the organisation of National Trials Meetings
(please see the website conference page). In addition, representatives of the NCRI Clinical Studies Groups
regularly participate in international and national cancer research meetings.

5.1 Publications 1997-2001
JOURNAL ARTICLES

CM Jenkinson, KM Muir, PG Hawtin & CED Chilvers: Attitudes and impressions of participants in a study of the
causes of childhood cancer. British Journal of Cancer 2001;84(3):413-416

UK Childhood Cancer Study Investigators: Childhood cancer and residential proximity to power lines. British
Journal of Cancer 2000;83(11):1573-1580

The United Kingdom Cancer Study: objectives, materials and methods. British Journal of Cancer
2000;82(5):1073-1102

UK Childhood Cancer Study Investigators: Exposure to power-frequency magnetic fields and the risk of
childhood cancer. The Lancet 1999; 354:1925-1931.

UKCCCR Strategy Group Workshop. Clinical endpoints in trials of biological agents. British Journal of Cancer
2000;83(3):294-297.

UKCCCR Strategy Group Workshop. Improvements in Patient Access to New Anti-Cancer Medicines. British
Journal of Cancer 1999;79(1):2-3.

Fitzpatrick R, Davies L. Health Economics and quality of life in cancer trials: report based on a UKCCCR
workshop. British Journal of Cancer 1998;77(10):1543-1548.

UKCCCR. Guidelines for the Welfare of Animals in Experimental Neoplasia (second edition). British Journal of
Cancer 1998;77(1):1-10.

Elderly Cancer Patients in Clinical Trials: conclusions of the UKCCCR Working Group (abstract). European
Journal of Surgical Oncology 1998;24:422.
BOOKLETS

UKCCCR Guidelines for the Use of Cell Lines in Cancer Research, March 1999.

UKCCCR Guidelines for the Welfare of Animals in Experimental Neoplasia. Second Edition, July 1997.

UKCCCR Colorectal Cancer Subcommittee. Handbook for the Clinico-pathological Assessment and Staging of
Colorectal Cancer. Second Edition, April 1997.

REPORTS

2nd UKCCCR Radiation Research Programme Final Report, July 2001.

NEWSLETTERS

Europe Against Cancer Newsletters are produced twice yearly.

5.2 Website http://ukcccr.icnet.uk/
The NCRI Clinical Studies Groups Secretariat (formerly UKCCCR) website went live in October 1998. The site
aims to enhance the communication and networking functions of the organisation, particularly between meetings.
To achieve this end specific pages covering the main areas of our work were established (see below).

The website will be incorporated into the new NCRN website when it goes live later this year
(http://www.ncrn.org.uk).
Home – provides an overview of the organisational remit, lists the Funding Bodies, and contact details.

Cancer Groups – details the membership and terms of reference for all the committees & groups. Reports from
the Chairmen are posted regularly.

Conferences – a calendar of forthcoming National Meetings, with a link to the UICC Register.

Publications - lists recent publications and provides links to full articles, newsletters and reports.

Trials Databases - provides a link to the UKCCCR Trials Register of all national phase III trials, and to all the
major national and international trials databases.

Links – provides access to the web sites of the Funding Bodies, to international cancer research and support
organisations, and to relevant academic journals.
6. FINANCIAL STATEMENT
The NCRI Clinical Studies Groups Secretariat does not have its own legal identity and does not, therefore,
operate its own bank account. Monies ascribed to NCRI Clinical Studies Groups activities by the Funding
Bodies or outside sources are therefore held on our behalf by one of the Funding Bodies and paid out against
the signature of the NCRI Clinical Studies Groups Senior Executive.




The figures below do NOT include the income/expenditure for specific cancer clinical trials developed by our
Groups. The precise funding arrangements vary between trials and may contain components where salaries
are paid directly by Funding Bodies to their own centres.

The budget for 2001-2002 was based on the budget for 2000-2001, although there was a significant
underspend in that financial year which was not thought likely to continue.

Core Secretariat Activities
                                             Final Accounts                                 Budget
                                               2000-2001                                   2001-2002
                                                    £                                          £
INCOME
Member Contributions1                             147,673                                    207,116
               2
Reimbursements                                      310
TOTAL                                             147,983                                    207,116

EXPENDITURE
          3
Personnel                                         79,936                                     125,856
Office Costs                                       9,211                                      14,563
Travel4                                           34,209                                      34,388
Catering                                           5,434                                      5,305
Accommodation                                     16,581                                      22,414
            5
Other Costs                                        2,612                                      4,590
TOTAL                                             152,929                                    157,824
1.   Provided equally by CRC, ICRF, LRF and MRC to support core Secretarial activities, along with contributions from the 5 Associate
     Members.
2.   Originally paid from Secretariat funds but reimbursed by individual trials.
3.   Includes salaries, recruitment and training.
4.   Mainly travel expenses for Group and Committee members.
5.   Includes meeting room hire and teleconferencing.

The NCRI Clinical Studies Groups Secretariat also administers the following
programme:
The Europe Against Cancer Programme is funded by the Department of Health and administered via a bank
account held on our behalf by the Cancer Research Campaign.



Programmes administered until 31/3/01:
1.   The Radiation Research Programme was sponsored by the nuclear industry and administered via a bank
     account held by the Cancer Research Campaign.

2.      The UK Childhood Cancer Study, funded by a number of charitable, Government and industrial
     organisations, was administered via a bank account held by LRF.
 NCRI Clinical Studies Groups
         PO Box 123
     Lincoln’s Inn Fields
           London
         WC2A 3PX
       UnitedKingdom

Telephone: 020 7269 3548/3249
      Fax: 020 7269 3398

 Email : ukcccr@icrf.icnet.uk
Website: http://ukcccr.icnet.uk/

				
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