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

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 Children and Adolescents Osteosarcoma

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.

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,