NCRI Lung Cancer Clinical Studies Group by yaohongm


									                                    Annual report 2006-7

 NCRI Lung Cancer Clinical Studies Group
 In the last year the pathway for the development of new trials proposals has been
 developed. All of the major UK interested parties have signed up to the new
 mechanism which is illustrated on the NCRI Lung CSG website and involves
 completing a single page form which can be downloaded from the website
 The group structure has been modified to optimise the pathway. A new Clinical Trials
 Subgroup has been formed, chaired by Nicky Gower of the CRUK and UCL Cancer
 Trials Centre and with representation from other interested lung trials units. The
 Clinical Trials Subgroup is able to advise on the conduct of all trials and does not
 have its own portfolio. The Group has been strengthened in 2007 by the
 appointment of a new Trials Portfolio Co-ordinator Dr Shelagh Bonner-Shand.

 At the 2007 BTOG meeting we held our first series of open subgroup meetings,
 which served both to ensure openness & accountability and to discuss new ideas.

 Portfolio and accrual
 Our current portfolio is as follows:

 SCEPTRE (Chair: Dr Mike Peake)
 The key tasks for this sub-group are to re-examine the possibility of screening trials
 and to develop smoking cessation studies.

Acronym              Title                                     PI(s)         Status
CLUB                 Cancer of the LUng Biomarkers             Prof Nicholas Open
Early Lung Cancer The use of molecular biomarkers in early Prof John Field Open
Study             lung cancer detection
(Lung) - SEARCH A randomised controlled trial of               Prof. Stephen In Set-
                  surveillance for the early detection of lung Spiro         up
                  in High-risk patients
MUSICAL           Mediastinal endoscopic UltraSound In the Dr Steve          Open
                  diagnosis and staging of CArcinoma of        Pereira
                  the Lung
ReSoLuCENT        Resource for the Study of Lung Cancer Prof. Penella        Open
                  Epidemiology in North Trent                  Woll

 Rare Tumours (Chair: Dr Stephen Falk)
 This sub group is developing trials for rarer thoracic malignancies for which few data
 currently exist and where there is a particular opportunity for national trials. The initial
 focus is likely to be on carcinoid and bronchioloalveolar tumours.

 Translational Research (Chair: Prof John Field)
 GELCAPS completed accrual in the past year and this has been reflected in patient
 accrual numbers for the Lung CSG. The particular roles of this sub-group is to 1)
 ensure that we maximise the translational potential of trials in the portfolio and 2)
 conduct observational studies such as those noted below.

Acronym              Title                                        PI(s)           Status
CLUB                 Cancer of the Lung Biomarkers                Prof Nicholas Open
LLP                  LLP Liverpool Lung Project                   Prof John Field Open
                                   Annual report 2006-7

 Mesothelioma (Chair: Mr David Waller)
 This subgroup continues to maintain a healthy portfolio of trials. The subgroup is
 working on the challenge of developing a new systemic therapy trial (MESO-2).

Acronym             Title                                       PI(s)           Status
Julian Peto's       A population based case-control study of Prof Julian Peto Open
Mesothelioma and    mesothelioma and lung cancer in relation
Lung Cancer Study   to occupation among British men and
(MALCS)             women under the age of 60
MARS                Mesothelioma and Radical Surgery trial. Prof Julian         Open
                    MARS pilot study - to determine the         Peto, Mr David
                    feasibility and acceptability of performing Waller, Prof
                    a randomised trial comparing extra-         Tom Treasure
                    pleural pneumonectomy (EPP) against no
                    EPP surgery within the context of
                    trimodality therapy (chemotherapy,
                    surgery, post-operative radiotherapy).
MS-01               A randomised controlled trial of active     Dr Martin Muers Closed
                    symptom control with or without
                    chemotherapy in the treatment of patients
                    with malignant pleural mesothelioma
VATS                Prospective randomised controlled trial of Dr Clare         Open
                    Video-Assisted ThoracoScopic (VATS)         Laroche, Mr AJ
                    cytoreductive pleurectomy compared to Ritchie, Dr
                    talc pleurodesis in patients with suspected Robert Winter
                    or proven malignant mesothelioma.
ADMIN-M             A randomised phase II trial of single agent Dr Peter        Open
                    ADI-PEG 20 (pegylated arginine              Szlosarek
                    deaminase) in patients with malignant
                    pleural mesothelioma

 NSCLC I-IIIA & SCLC LD (Chair: Prof Allan Price)
 This subgroup focuses on treatments with radical intent and in difficult disease areas.
 These are difficult trials to perform and a review of recruitment successes and
 failures will take place later in 2007.

Acronym             Title                                       PI(s)            Status
GRIN                A phase III study of radical radiotherapy   Prof Allan Price Suspended
                    with or without gemcitabine in patients
                    with T1-2 N0-1 M0 non-small cell lung
INCH                A randomised phase II/III trial of          Dr Matthew     Open
                    induction chemotherapy followed by          Hatton
                    continuous hyperfractionated
                    accelerated radiotherapy (CHART)
                    versus CHART alone in patients with
                    inoperable non-small cell lung cancer.
SOCCAR              A randomised phase III trial of             Dr Joe Maguire Open
                    sequential chemotherapy followed by
                    radical radiotherapy versus concurrent
                    chemo-radiotherapy followed by
                    chemotherapy in patients with
                                 Annual report 2006-7

                  inoperable stage III non-small cell lung
                  cancer and good performance status.

 NSCLC IIIB/IV & SCLC ED (Chair: Prof David Ferry till Spring 2007(Now Dr
 Marianne Nicolson)

Acronym           Title                                         PI(s)             Status
BTOG2             British Thoracic Oncology Group (BTOG) Prof David               Open
                  phase III trial of gemcitabine plus cisplatin Ferry
                  at 80 mg/m2 vs gemcitabine plus cisplatin
                  at 50mg/m2 gemcitabine plus carboplatin
                  AUC 5 in stage IIIB/IV Non-Small Cell
                  Lung Cancer (NSCLC)
FRAGMATIC         A randomised phase III clinical trial         Dr Fergus         In Set-
                  investigating the effect of FRAGMin           MacBeth           up
                  Added to standard Therapy In patients
                  with lung Cancer
GEM               A pragmatic, randomised study to              Prof Nick         Closed
Hospitalisation   compare the hospitalisation rates of two Thatcher
                  platinum-based outpatient regimens
                  (gemcitabine/ cispatin vs. gemcitabine/
                  carboplatin) in Non-Small Cell Lung
                  Cancer (NSCLC)
LLCG Study 12     A phase III randomised, double-blind,         Dr S M Lee        Closed
                  Placebo controlled trial of carboplatin/
                  etoposide with or without Thalidomide in
                  small cell lung cancer
LLCG Study 14     A phase II/III randomised, double blind, Dr S M Lee             Closed
                  placebo controlled trial of Gemcitabine/
                  carboplatin with or without thalidomide in
                  advanced Non-Small Cell Lung Cancer
LLP               LLP Liverpool Lung Project                    Prof John Field   Open
LungStar          A multicentre phase III randomised            Prof M J Seckl    Open
                  double blind placebo controlled trial of
                  pravastatin added to first-line standard
                  chemotherapy in patients with small cell
                  lung cancer
3QUARTZ           A phase III multicentre randomised            Dr Paula          Open
                  controlled trial to assess whether optimal Mulvenna
                  supportive care (including
                  dexamethasone) alone is as effective as
                  optimal supportive care (including
                  dexamethasone) and whole brain
                  radiotherapy (WBRT) in the treatment of
                  patients with NSCLC with inoperable
                  brain metastases.
T- FRAG           Storage of tissue and blood samples from Mr G Griffiths         Open
                  patients in the FRAGMATIC trial
TACTIC            A randomised phase II double cline            Dr Siow Ming      In Set-
                  placebo controlled trial of Whole Brain       Lee               up
                  Radiotherapy (WBRT) and Tarceva (OSI-
                  774, erlotinib) in patients with advanced
                  Non-Small Cell Lung Cancer (NSCLC)
                  with multiple brain metastases
                                   Annual report 2006-7

Topical             Tarceva or placebo in clinically advanced Dr Siow Ming        Open
                    non-small cell lung cancer                  Lee
TRANSMATIC          A pilot study to assess the utility of      Dr Fergus         In Set-
                    quantitative methylation specific PCR (Q- Macbeth             up
                    MSP) in the quantitative identification of
                    cancer cell dissemination in the peripheral
                    circulation of lung cancer patients

 Two new studies were funded at the June 2006 CTAAC meeting, SEARCH – a
 randomised control trial of surveillance for the early detection of lung cancer in a high
 risk group, and ADMINM – a randomised stratified phase II multicentre clinical trial of
 single agent ADI-PEG20 (pegylated arginine deiminase) in patients with malignant
 pleura mesothelioma. Both of these are now open and should increase recruitment in

 1142 patients were recruited to lung studies in 2006/07, representing 4.1% of total
 UK accrual and 3.1% of incident cases. This compares with 2864 patients recruited
 in 2005/06

 The following studies closed before the period under review:

Acronym             Title                                        PI(s)            Status
BLT                 A randomised trial of cisplatin-based        Ms N Gower       Closed
                    chemotherapy for patients with all stages
                    of non-small cell lung cancer.
DOCMIC              A randomised study of docetaxol with         Prof. N          Closed
                    carboplatin vs mitomycin, vinblastine,       Thatcher
                    cisplatin (MVP) or mitomycin, ifosfamide
                    and cisplatin (MIC) in inoperable
                    advanced Non-Small Cell Lung Cancer
Fitness for surgery Prospective study to assess the ability of   Dr C Laroche,    Closed
                    the new BTS guidelines to assess fitness     Dr T Win
                    for surgery in patients undergoing lung
                    resection for lung cancer
GELCAPS             Genetic Lung Cancer Predisposition           Professor Tim    Closed
                    Study: a molecular epidemiology study        Eisen
LLCG Study 10       A phase III randomised comparison of         Dr R Rudd        Closed
                    gemcitabine/carboplatin with
                    cisplatin/etoposide in small cell lung
LLCG Study 11       A phase III randomised comparison of         Dr R Rudd        Closed
                    gemcitabine/ carboplatin (GC) with
                    mitomycin/ ifosfamide/ cisplatin (MIC) in
                    Non-Small Cell Lung Cancer (NSCLC)
LU21                Randomised clinical trial of ifosfamide,     Prof. N          Closed
                    carboplatin and etoposide with mid-cycle     Thatcher
                    vincristine (VICE) versus standard
                    practice chemotherapy in patients with
                    limited small-cell lung cancer (SCLC) and
                    good performance status
LU22                A randomised trial of surgical resection     Mr Peter      Closed
                    with or without pre-operative                Goldstraw, Ms
                    chemotherapy in patients with operable       Penelope
                                 Annual report 2006-7

                Non-Small Cell Lung Cancer (NSCLC) of Hopwood, Dr
                any stage                                 Marianne
                                                          Professor Ian
MESO-1          Randomised feasibility study of active    Dr M Muers        Closed
                symptom control with or without
                chemotherapy in the treatment of patients
                with mesothelioma
ThalidomideSCLC Thalidomide in Small Cell Lung Cancer                       Closed
TIME            Time to consult with symptoms of lung                       Closed
                cancer: Is it related to deprivation or
TR8SCLC         A randomised study of timing of thoracic                    Closed
                irradiation in small cell lung cancer

 Dr Dean Fennell, Dr Paul Aveyard and Dr Rhona McMenemin were all appointed to
 the Group in February 2007. Dr Marianne Nicolson took over as chair of the SCLC
 IIIB/IV & SCLC ED Subgroup in the spring of 2007. Dr Michael Cullen, Dr Christian
 Ottensmeier, Professor Stephen Spiro and Professor Nick Thatcher all left the Group
 during the February membership rotation. There hard work whilst serving as a
 member of the Group is very much appreciated.

 These for the reporting year can be found in Appendix 1.

 Other activities
 Members of the CSG actively participated in the Lung SPG. The Group held
 successful sessions at the October 2006 NCRI and January 2007 BTOG Cancer

 Future priorities
 Our major priorities for the next three years are:
        1. To continue to develop and maintain a portfolio of studies answering
           important issues in lung cancer.
        2. To develop a screening study in the UK.
        3. To continue development of a highly effective trials development

 Professor Tim Eisen, Chair

                                Annual report 2006-7

Appendix 1

NCRI-Lung Cancer CSG 2006/07 Publications and Abstracts Report

Spiro SG, James LE, Rudd RM, Trask CW, Tobias JS, Snee M, Gilligan D, Murray
PA, Ruiz de Elvira MC, O'Donnell KM, Gower NH, Harper PG, Hackshaw AK;
London Lung Cancer Group. Early compared with late radiotherapy in combined
modality treatment for limited disease small-cell lung cancer: a London Lung Cancer
Group multicenter randomized clinical trial and meta-analysis. J Clin Oncol. 2006
Aug 20; 24(24): 3823-30.


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