International co-operation in radiation oncology

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International co-operation in radiation oncology

  1. 1. 1 International co-operation in radiation oncology: Philip Poortmans, MD, PhD On behalf of the EORTC Radiation Oncology Group Prepared for a meeting in January 2010
  2. 2. 2 • 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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  6. 6. 6 • 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
  7. 7. 7 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
  8. 8. 8 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
  9. 9. 9 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
  10. 10. 10 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
  11. 11. 11 • 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.
  12. 12. 12 • 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.
  13. 13. 13 • 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.
  14. 14. 14 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
  15. 15. 15 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 Philippe Maingon (Dijon) Damien Weber Clinical Co-chair QA RT SC/Team
  16. 16. 16 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)
  17. 17. 17 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
  18. 18. 18 Current ROG trialsCurrent ROG trials Trial number Status 22071-24071 Head – Neck Study Coordinator: W Budach Full protocol in development Educational grant Accrual: Pre-study: / 150 pts Main study: / 800 pts 22042-26042 Meningioma Study Coordinator: Damien Weber Open 23 pts/68 (07.12.09) Academic trial 22043-30041 Prostate Study Coordinator: M Bolla - H Van Poppel Open Accrual: 2 / 600 pts (07.12.2009) Educational grant 22085-10083 DCIS Mailbox (TROG/BIG study) Study Coordinator: H. Westenberg Regulatory in process Academic trial Accrual: 200 pts (EORTC+BOOG) / 610 (total) 22051-10052 Supremo Mailbox (ISD lead) Study Coordinator: G. Van Tienhoven Open 128 EORTC (07.12.09) / 579 in total (23.11.09) Academic trial 22991 Prostate Study Coordinator: M. Bolla Closed (30/04/2008) Accrual: 819 / 800 pts Academic trial 22073-26072 Glioblastoma Study Coordinator: A Grosu On hold Academic trial
  19. 19. 19 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
  20. 20. 20 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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  25. 25. 25 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 EORTC Headquarters EORTC Radiation Oncology Group QART committeeHQ QART EORTC trial with radiotherapy QART team = ROG + HQ QART
  26. 26. 26 The need for global cooperation and harmonisation
  27. 27. 27 ICARO 28 April 2009, Vienna Project proposal: GloVal GLObal VALidation of clinical trials radiation therapy quality assurance software using a sustainable DICOM dataset
  28. 28. 28 Forum on program harmonisation Forum on digital data handling Global trial RTQA harmonisation ICARO 28 April 2009, Vienna
  29. 29. 29 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.
  30. 30. 30  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
  31. 31. 31 ⇒Delegates from the manufacturers and from the RTOG, EORTC and TROG Proposed project members:
  32. 32. 32  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:
  33. 33. 33 ITC remote review tool CERR Mimvista VelocityAI RT-View Swan VodcaRT A joint effort!
  34. 34. 34 A joint effort
  35. 35. 35 11-13 March 2010 Barcelona, Spain
  36. 36. 36 Thanks for your attention ROG Executive CommitteeROG Executive Committee ROG + HQ / QART subcommitteeROG + HQ / QART subcommittee Brigitta Baumert Radiation Oncologist Maastro Clinic, Maastricht The 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 websites http://www.eortc.behttp://www.eortc.be http://group.eortc.be/radiohttp://group.eortc.be/radio Paul Fenton
  37. 37. 37 The end

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