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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.

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euramos 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

euramos
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
euramos3
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.
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EURAMOS 1
  • Co-sponsored
    • MRC in Europe
    • COG for North America
  • Co-ordinating Data Centre
    • MRC Clinical Trials Unit
trial design6
Trial Design
  • Key registration criteria
    • High grade OS of extremity or axial skeleton
    • Resectable disease
    • Fit for treatment
trial design7
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 design8
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 design9
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
Trial Design- additional studies
  • Quality of Life
  • Biology Studies
progress requests to join
Progress: requests to join
  • Czech Republic
  • Ireland
  • Poland
  • Israel
accrual
Accrual

302 Registered

accrual16
Accrual
  • 302 Registered
accrual17
Accrual

123 Randomised

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