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

This study has been completed.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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
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:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

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

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,
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Please refer to this study by its identifier: NCT00180908

Institut Gustave-Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Chantal Kalifa, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided by Gustave Roussy, Cancer Campus, Grand Paris

Additional publications automatically indexed to this study by Identifier (NCT Number): 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 Gustave Roussy, Cancer Campus, Grand Paris:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Etoposide phosphate
Isophosphamide mustard
Liposomal doxorubicin
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action processed this record on December 01, 2015