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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180908
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

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.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 1994

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

Secondary Outcome Measures :
  1. Event-free survival,
  2. Overall survival,
  3. Toxicity.

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00180908     History of Changes
Other Study ID Numbers: OS94
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:

Additional relevant MeSH terms:
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Etoposide phosphate
Isophosphamide mustard
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors