Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180908
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteosarcoma
Localised High Grade Osteosarcoma of the Limbs
 Drug: Etoposide, Ifosfamide, Methotrexate
Drug: Doxorubicin, Methotrexate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Good histological response (5% or less viable cells) after preoperative chemotherapy

Secondary Outcome Measures:
  • Event-free survival,
  • Overall survival,
  • Toxicity.

Estimated Enrollment: 226
Study Start Date: June 1994
  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180908

Locations
France
Institut Gustave-Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Study Chair: Chantal Kalifa, MD Institut Gustave Roussy
  More Information

No publications provided by Institut Gustave Roussy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00180908     History of Changes
Other Study ID Numbers: OS94, CSET-94-300
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
Osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Doxorubicin
Etoposide phosphate
Isophosphamide mustard
Etoposide
Ifosfamide
Methotrexate
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 23, 2013