Skip to main content
OpenTrials
Completed

NCT Number: NCT00180908

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteosarcoma Localised High Grade Osteosarcoma of the Limbs Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Gustave-Roussy

Villejuif, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Etoposide, Ifosfamide, Methotrexate

Drug

Doxorubicin, Methotrexate

Drug

Primary outcomes

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

Secondary outcomes

  1. Event-free survival,

  2. Overall survival,

  3. Toxicity.

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Important dates

Study start
1994
First posted
Sep 16, 2005
Registry last updated
Sep 16, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.