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EURAMOS 1

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  1. EURAMOS 1 A randomised trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy Jeremy Whelan for the EURAMOS 1 Trial Management Group, 4th November 2006

  2. EURAMOS • EURAMOS is the European and American Osteosarcoma Study Group. The study was founded in 2001. • Children’s Oncology Group • Cooperative Osteosarcoma Study Group • European Osteosarcoma Intergroup • Scandinavian Sarcoma Group

  3. EURAMOS • Established Oct 2001 • Aim • to improve survival from OS • Objectives • to carry out large international randomised trials • to facilitate biological research • to seek new therapeutic approaches • to develop common understanding and methodologies for staging, pathology etc.

  4. EURAMOS 1 • Co-sponsored • MRC in Europe • COG for North America • Co-ordinating Data Centre • MRC Clinical Trials Unit

  5. Trial Design

  6. Trial Design • Key registration criteria • High grade OS of extremity or axial skeleton • Resectable disease • Fit for treatment

  7. Trial Design • Key randomisation criteria • Adequate pre-operative chemotherapy • Macroscopically complete resection of primary tumour • Complete removal of all metastases or complete removal planned and feasible • Histological response assessment

  8. Trial Design • Primary Objectives • Addition of IE to post-op MAP chemotherapy improves EFS for poor responders • Addition of ifn to post-op MAP chemotherapy improves EFS for good responders

  9. Trial Design • Secondary Objectives • Additional treatment improves OS, short and long term toxicity and quality of life • Additional treatment improves EFS in localised disease • Investigate biological and clinical correlated to histological response and outcome • International cooperation in trials • Examine outcome of the entire cohort of patients

  10. Trial Design- additional studies • Quality of Life • Biology Studies

  11. EURAMOS participants

  12. Progress: open and recruiting

  13. Progress: almost ready • Austria • Finland

  14. Progress: requests to join • Czech Republic • Ireland • Poland • Israel

  15. Accrual 302 Registered

  16. Accrual • 302 Registered

  17. Accrual 123 Randomised

  18. EURAMOS 1 • Chief Investigators • Mark Bernstein (TMG Chair) • Neyssa Marina (COG) • Stephan Bielack (COSS) • Jeremy Whelan (EOI) • Sigbjorn Smeland (SSG) • Website • www.euramos.org