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

Gustave Roussy

Status and phase: Completed; Phase 3

Conditions: Osteosarcoma; Localised High Grade Osteosarcoma of the Limbs

Treatments: Drug: Doxorubicin, Methotrexate; Drug: Etoposide, Ifosfamide, Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00180908

CSET-94-300

OS94

Details and patient eligibility

About

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.

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)