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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.
EURAMOS 1

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Slide 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

Slide 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

Slide 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.

Slide 4

EURAMOS 1

  • Co-sponsored

    • MRC in Europe

    • COG for North America

  • Co-ordinating Data Centre

    • MRC Clinical Trials Unit

Slide 5

Trial Design

Slide 6

Trial Design

  • Key registration criteria

    • High grade OS of extremity or axial skeleton

    • Resectable disease

    • Fit for treatment

Slide 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

Slide 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

Slide 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

Slide 10

Trial Design- additional studies

  • Quality of Life

  • Biology Studies

Slide 11

EURAMOS participants

Slide 12

Progress: open and recruiting

Slide 13

Progress: almost ready

  • Austria

  • Finland

Slide 14

Progress: requests to join

  • Czech Republic

  • Ireland

  • Poland

  • Israel

Slide 15

Accrual

302 Registered

Slide 16

Accrual

  • 302 Registered

Slide 17

Accrual

123 Randomised

Slide 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



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