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, 4 th November 2006

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

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.

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

Trial Design

Key registration criteria  High grade OS of extremity or axial skeleton  Resectable disease  Fit for treatment

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

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

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

Trial Design- additional studies Quality of Life Biology Studies

EURAMOS participants

Progress: open and recruiting RegisteredRandomised USA11140 Germany8742 UK4217 Netherlands145 Norway114 Canada102 Belgium95 Switzerland85 Sweden53 Demark20 Hungary10 Australia20 Total302123

Progress: almost ready Austria Finland

Progress: requests to join Czech Republic Ireland Poland Israel

Accrual 302 Registered

Accrual 302 Registered

Accrual 123 Randomised

EURAMOS 1 Chief Investigators  Mark Bernstein (TMG Chair)  Neyssa Marina (COG)  Stephan Bielack (COSS)  Jeremy Whelan (EOI)  Sigbjorn Smeland (SSG) Website 