Status:

COMPLETED

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

Lead Sponsor:

Gustave Roussy, Cancer Campus, Grand Paris

Conditions:

Osteosarcoma

Localised High Grade Osteosarcoma of the Limbs

Eligibility:

All Genders

Up to 20 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

June 1 1994

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

226 Patients enrolled

Trial Details

Trial ID

NCT00180908

Start Date

June 1 1994

Last Update

September 16 2005

Active Locations (1)

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1

Institut Gustave-Roussy

Villejuif, France, 94805