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

Gustave Roussy, Cancer Campus, Grand Paris226 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

226

Conditions

Osteosarcoma Localised High Grade Osteosarcoma of the Limbs

Interventions

Etoposide, Ifosfamide, MethotrexateDRUG

Doxorubicin, MethotrexateDRUG

Eligibility

Sex: ALLMax age: 20 Years

Medical Language ↔ Plain English

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,

Locations (1)

Institut Gustave-Roussy

Villejuif, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

Event-free survival,

Overall survival,

Toxicity.

Data from ClinicalTrials.gov

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