EURAMOS 1

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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, 4th November 2006
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EURAMOS

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

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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

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Trial Design
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Trial Design

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

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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

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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

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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

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Trial Design- additional studies

• Quality of Life
• Biology Studies

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EURAMOS participants
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Progress open and recruiting
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Progress almost ready

• Austria
• Finland

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Progress requests to join

• Czech Republic
• Ireland
• Poland
• Israel

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Accrual
302 Registered
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Accrual

• 302 Registered

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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