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Sponsored by: |
Institut Gustave Roussy |
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Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00180908 |
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 |
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Osteosarcoma Localised High Grade Osteosarcoma of the Limbs |
Drug: Etoposide, Ifosfamide, Methotrexate Drug: Doxorubicin, Methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | OS94, CSET-94-300 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00180908 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Osteosarcoma |
Malignant mesenchymal tumor Osteosarcoma Osteogenic sarcoma Etoposide phosphate Soft tissue sarcomas Doxorubicin Folic Acid |
Neoplasms, Connective and Soft Tissue Ifosfamide Mechlorethamine Sarcoma Methotrexate Etoposide Isophosphamide mustard |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibiotics, Antineoplastic Therapeutic Uses Abortifacient Agents Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Neoplasms by Histologic Type Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms, Bone Tissue Antineoplastic Agents, Alkylating Neoplasms, Connective Tissue Antirheumatic Agents Antineoplastic Agents, Phytogenic |