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International co-operation in radiation

oncology:

Philip Poortmans, MD, PhDOn behalf of the EORTC Radiation Oncology Group

Prepared for a meeting in January 2010

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• 300 hospitals/cancer centres in > 30 countries;

• ~ 2,900 collaborators involved in cancer treatment and research;

• ~ 5,000 new patients enrolled each year;

• ~ 50 trials open to patient entry;

• ~ 50,000 patients in follow-up;

• database of > 150,000 patients.

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• 1962, Henri Tagnon and a few pioneers: GECA

• 1968 renamed into EORTC

• 1962: Maurice Tubiana, Klaas Breur and Jacques Henry: Radio-Chemotherapy Group: first Hodgkin trials

• 1973: split Hodgkin & Non-HodgkinGroup (later Lymphoma Group) and Radiotherapy Group

• January 10, 1975 in Creteil: first independent meeting with Claude Lalanne, Jean-Claude Goffin, Alain Laugier and Jean-Claude Horiot

• 1978, first protocol: V-22781, pelvic radiotherapy versus extended fields to para-aortic nodes in cervix cancers

• Emmanuel van der Schueren, Jean-Claude Horiot and Walter van den Bogaert: altered fractionation schemes and radio-sensitisers

• Karl-Axel Johansson, Emmanuel van der Schueren, Jean-Claude Horiot, Guido Garavaglia, Harry Bartelink, Jacques Bernier, Bernard Davis and many others: QA

• Joint research ventures with other EORTC groups; Urology, Gastro-Intestinal, Brain and Breast

• Nineties: "mega-trials“

• Restructuring meetings in parallel sessions for disease-oriented working parties

• 21st century: more than 3500 patients: >> other EORTC groups

• Evaluation of high precision radiotherapy: 3D-CRT & IMRT

• 2006: renamed into “Radiation Oncology Group”

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Aims:• To improve local control and survival• To improve organ preservation • To improve quality of life • To improve treatment management and QA in RT

departmentsStrategies:• Elaboration of new randomised trials aiming at the most efficient integration of radiotherapy

with other treatment modalities (i.e. surgery, chemotherapy, hormone therapy) into a whole range of cancer sites, in close cooperation with other EORTC groups or international organisations

• Integration of innovative modalities into radiotherapy such as new classes of therapeutic agents (radiation modifiers, anti-angiogenesis compounds and gene therapy)

• Integration of novel radiation techniques such as IMRT, allowing dose-escalation studies

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Aims:• To improve local control and survival• To improve organ preservation • To improve quality of life • To improve treatment management and QA in RT departments

Strategies:• Elaboration of new randomised trials aiming at the most

efficient integration of radiotherapy with other treatment modalities (i.e. surgery, chemotherapy, hormone therapy) into a whole range of cancer sites, in close cooperation with other EORTC groups or international organisations

• Integration of innovative modalities into radiotherapy such as new classes of therapeutic agents (radiation modifiers, anti-angiogenesis compounds and gene therapy)

• Integration of novel radiation techniques such as IMRT, allowing dose-escalation studies

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Aims:• To improve local control and survival• To improve organ preservation • To improve quality of life • To improve treatment management and QA in RT departments

Strategies:• Elaboration of new randomised trials aiming at the most efficient integration of radiotherapy with other

treatment modalities (i.e. surgery, chemotherapy, hormone therapy) into a whole range of cancer sites, in close cooperation with other EORTC groups or international organisations

• Integration of innovative modalities into radiotherapy such as new classes of therapeutic agents (radiation modifiers, anti-angiogenesis compounds and gene therapy)

• Integration of novel radiation techniques such as IMRT, allowing dose-escalation studies

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Aims:• To improve local control and survival• To improve organ preservation • To improve quality of life • To improve treatment management and QA in RT departments

Strategies:• Elaboration of new randomised trials aiming at the most efficient integration of radiotherapy with other

treatment modalities (i.e. surgery, chemotherapy, hormone therapy) into a whole range of cancer sites, in close cooperation with other EORTC groups or international organisations

• Integration of innovative modalities into radiotherapy such as new classes of therapeutic agents (radiation

modifiers, anti-angiogenesis compounds and gene therapy)

• Integration of novel radiation techniques such as IMRT, allowing dose-escalation studies

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• Early external irradiation improves progression-free survival in low grade astrocytoma and oligodendroglioma. Karim et al. IJROBP 2002.

• Low dose irradiation to the para-aortic nodes and liver does not improve survival for resected adenocarcinoma of the rectum. Bosset et al. R&O 2001.

• Results boost/no boost study: a boost of 16 Gy to the tumour bed reduces the risk of local recurrence. Bartelink et al. NEJM 2001 & JCO 2007.

• Dummy run procedure identifies potential systematic protocol deviations, avoidable by provision of recommendations. Poortmans et al. IJROBP 2001.

• Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer. Bolla et al. Lancet 2002.

• Post-operative irradiation with concomitant cisplatinum improves DFS and OS of high-risk locally advanced H&N cancer patients. Bernier et al. NEJM 2004.

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• Post-operative radiotherapy after radical prostatectomy improves DFS of patients with cT2/pT3 prostate cancer. Bolla et al: Lancet 2005.

• Concomitant chemotherapy enhances the tumorocidal effect of pre-operative irradiation in patients with rectal cancer. Bosset et al. JCO 2005.

• Concomitant chemotherapy by temozolomide improves OS of patients with glioblastoma multiforme treated by radiotherapy. Stupp et al. NEJM 2005.

• Breast-conserving treatment with or without radiotherapy for DCIS: Ten-year results. Bijker et al: JCO 2006.

• Chemotherapy with preoperative radiotherapy in rectal cancer. Bosset et al: N Engl J Med 2006.

• Quality assurance works. Poortmans et al: Strahlenther Onkol 2006.

• Guidelines for primary/post-operative radiotherapy of patients with prostate cancer. Boehmer/Poortmans et al: Radiother Oncol 2006 & 2007.

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• Involved-node radiotherapy (INRT) in patients with early Hodgkin lymphoma: concepts and guidelines. Girinsky et al: Radiother Oncol 2006 & 2008.

• Prophylactic Cranial Irradiation in Extensive Disease Small Cell Lung Cancer. Slotman et al: N Engl J Med 2007.

• Standard versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer. Le Péchoux et al: Lancet Oncol 2009.

• Long term or short term androgen suppression combined with irradiation in locally advanced prostate cancer. Bolla et al: N Engl J Med 2009.

• Radiotherapy volume and treatment guidelines for neoadjuvant radiation of adenocarcinomas of the gastroesophageal junction and the stomach. Matzinger et al: Radiother Oncol 2009.

• Impact of the boost dose in patients with early stage breast cancer after a microscopically incomplete lumpectomy. Poortmans et al: Radioth Oncol 2009.

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CONCLUSION

These advances have been progressively translated into daily clinical

practice, demonstrating the EORTC Radiation Oncology Group’s

contribution to improving results using new radiotherapy

techniques alone or in combination with other modalities

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ROG Executive Committee

Steering Committee:ROG Executive

QA RT Strategic Ctee & QA RT Team Chairs

ROG Working Party Coordinators

ROG Study Coordinators

ROG Committee Chairs:

Website and PR Committee: A. Kuten

Membership Committee: A. van den Bergh

Publication Committee: D. Weber

Chair RTT Group: F. Duclos

Young Oncologist: E. Dieleman, Amsterdam

EORTC Headquarters Team

Co-chairs of joint studies

Vincent Grégoire

(Brussels)Chair

Karin Haustermans

(Leuven)Post-chair

Edwin Aird Physics Co-

chair QA RT Team

Coen Hurkmans Physics Co-

chair QA RT SC

Philippe Maingon(Dijon)

Treasurer

Damien Weber Clinical Co-chair QA RT SC/Team

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Breast Cancer: Helen Westenberg (Arnhem, NL)

Abraham Kuten (Haifa, IL)

Lung Cancer: Cécile Le Péchoux (Villejuif, F)

Head and Neck Cancer: Wilfried Budach (Düsseldorf, D)

Hans Langendijk (Groningen, NL)

Gastro-intestinal Tract: Oscar Matzinger (Lausanne, CH),

Philippe Maingon (Dijon, F)

Genito-urinary Cancer: Christopher Scrase (Ipswich, UK)

Fons van den Bergh (Groningen,

NL)

Brain Tumours: Damien Weber (Geneva, CH)

Sara Erridge (Edinburgh, UK)

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Frederic Duclos(Lausanne) 

Chair & Contact person

Marjolein van Os(Rotterdam) 

Scientific supervisor

Hans Paul van der Laan

(Groningen)Scientific supervisor

                                                          

 Bruno Speleers (Gent)

Projects supervisor

Bert Pastoors(Geneve) Secretary

P. Maingon(Dijon)

Treasurer

English, Catalan, French,  Italian, Spanish 

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Current ROG trialsCurrent ROG trials

Trial number Status

22071-24071Head – NeckStudy Coordinator: W Budach

Full protocol in development Educational grant Accrual: Pre-study: / 150 pts Main study: / 800 pts

22042-26042MeningiomaStudy Coordinator: Damien Weber

Open23 pts/68 (07.12.09)Academic trial

22043-30041ProstateStudy Coordinator: M Bolla - H Van Poppel

OpenAccrual: 2 / 600 pts (07.12.2009)Educational grant

22085-10083 DCISMailbox (TROG/BIG study)Study Coordinator: H. Westenberg

Regulatory in processAcademic trialAccrual: 200 pts (EORTC+BOOG) / 610 (total)

22051-10052 SupremoMailbox (ISD lead)Study Coordinator: G. Van Tienhoven

Open128 EORTC (07.12.09) / 579 in total (23.11.09)Academic trial

22991 ProstateStudy Coordinator: M. Bolla

Closed (30/04/2008) Accrual: 819 / 800 pts Academic trial

22073-26072GlioblastomaStudy Coordinator: A Grosu

On holdAcademic trial

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Trial number Specific items / Problems / Action

20971-22997 Lymphoma Closed 2009

10981-22023 AMAROS Accruing; end expected 2010

26082-22081: Temsirolimus Under preparation

26053-22054 CATNON, Anaplastic Glioma Open

26062-22061 Elderly GBM Mailbox (Canada lead) Open

22033-26033 Low grade Gliomas Accruing

26081-22086 Codeleted Mailbox (NCCTG lead) Under preparation

26071-22072 Cilengitide Starting; QA lead by EORTC ROG

2609X-2209X Under preparation

08072-22074 CONVERT 1 site to be opened in the NL, Slovenia and Poland still not opened

40013-22012 Pancreas Closed. Full paper is being drafted.

40054- 22062 PETACC6 Intergroup, EORTC lead Accruing

40084-22084 (RTOG0848) Under preparation. ERDA site study is being developed.

40081-22083 IMAGE trial Under preparation

Closed. Imaging review started.

Closed

24081-22082: locally advanced HN Under preparation

Trials, not ROG-leadTrials, not ROG-lead

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ChallengesChallenges

• Complexity of the organisation of clinical trials.

• Costs related to the conduct of clinical trials.

• Limited nr of members accrue majority of patients.

time and money

dependency of supporters (companies!)

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EORTC HQ and ROG / QART

Full-time employed at HQFull-time employed at HQ EvdS fellow (radiation oncologist)EvdS fellow (radiation oncologist) QART manager (medical physicist)QART manager (medical physicist)

Main responsibilitiesMain responsibilities CoordinationCoordination PreparationPreparation OrganizationOrganization ReportReport

Professional volunteersProfessional volunteers 3 radiation oncologist3 radiation oncologist 4 medical physicist4 medical physicist 1 radiation technologist1 radiation technologist

Main responsibilitiesMain responsibilities Expert opinionExpert opinion Determination of QART levelDetermination of QART level Validation / finalizationValidation / finalization

EORTCHeadquarters

EORTC Radiation Oncology Group

QART committeeHQ QART

EORTC trial with radiotherapy

QART team =ROG + HQ QART

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The need for global cooperation and harmonisation

27ICARO 28 April 2009, Vienna

Project proposal: GloVal

GLObal VALidation of clinical trials radiation therapy quality assurance software using a

sustainable DICOM dataset

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Forum on program harmonisation

Forum on digital data handling

Global trial RTQA harmonisation

ICARO 28 April 2009, Vienna

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Project goals

Commonly accessible DICOM dataset for validation

testing of RTQA software tools.

Clinical validation test protocol for RTQA software

based on international guidelines.

Test RTQA software tools using this DICOM dataset

and the clinical validation test protocol.

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RTQA platforms used by RTOG, EORTC or TROG:

VodcaRT from Medical Software Solutions

CERR software

ITC remote review tool

VelocityAI from Velocity Medical Solutions

Mim software from Mimvista

Artiview from Aquilab

Swan

RTQA software to be tested

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Delegates from the manufacturers and

from the RTOG, EORTC and TROG

Proposed project members:

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Draft project proposal: March 2009 till August 2009

Pilot validation tests of Vodca (EORTC): till July 2009

Full project proposal incl. finances: October 2009

Provisional timeline:

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ITC remote review tool

CERR

Mim

vista

VelocityAI

RT

-View

Sw

an

VodcaRT

A joint effort!

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A joint effort

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11-13 March 2010

Barcelona, Spain

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Thanks for your attention

ROG Executive CommitteeROG Executive Committee ROG + HQ / QART subcommitteeROG + HQ / QART subcommittee

Brigitta BaumertRadiation Oncologist

Maastro Clinic, MaastrichtThe Netherlands

Vincent Grégoire(Brussels)

Chair

Karin Haustermans(Leuven)

Post-chair

Edwin Aird Physics Co-chair

QA RT Team

Coen Hurkmans Physics Co-chair

QA RT SC

Philippe Maingon(Dijon)

Treasurer

Damien Weber Clinical Co-chair QA RT SC/Team

Please visit our websitesPlease visit our websiteshttp://www.eortc.be http://group.eortc.be/radio

Paul Fenton

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The end