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

Phase 3

Completed

• Conditions: Osteosarcoma; Localised High Grade Osteosarcoma of the Limbs

• Registration Number: NCT00180908
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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 Description

Not available

Study Timeline

• Study Start: 1994-06
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-16
• Last Update Posted: 2005-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• non metastatic limb osteosarcoma,
• age less than 20 years,
• biopsy proven high-grade osteosarcoma,
• no previous treatment,
• no contraindication to chemotherapy
• no previous malignancy,
• Written informed consent.

Exclusion Criteria

• juxta-cortical sarcoma and microcellular anaplastic sarcoma,
• previous anticancer treatment
• contraindication to chemotherapy
• previous malignancy,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Good histological response (5% or less viable cells) after preoperative chemotherapy

Secondary Outcome Measures

Name	Time	Method
Event-free survival,
Overall survival,
Toxicity.

Trial Locations

Locations (1)

Institut Gustave-Roussy; 🇫🇷 Villejuif, France