Clinical Trial: Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Ch

Brief Summary: The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.

Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: Good histological response (5% or less viable cells) after preoperative chemotherapy

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Event-free survival,
  • Overall survival,
  • Toxicity.


Original Secondary Outcome: Same as current

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: September 12, 2005
Date Started: June 1994
Date Completion:
Last Updated: September 12, 2005
Last Verified: September 2005