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Sponsored by: |
Societe Internationale d'Oncologie Pediatrique |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002898 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery and/or radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying surgery followed by different regimens of combination chemotherapy given together with radiation therapy and/or additional surgery to compare how well they work in treating patients with soft tissue sarcoma.
Condition | Intervention | Phase |
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Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: epirubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: brachytherapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood |
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary soft tissue sarcoma:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic:
Chemotherapy:
Endocrine:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Institute of Child Health | |
Bristol, England, United Kingdom, BS2 8AE |
Study Chair: | M. C. G. Stevens, MD | Institute of Child Health at University of Bristol |
Study ID Numbers: | CDR0000065228, SIOP-MMT-95, EU-96035 |
Study First Received: | November 1, 1999 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002898 |
Health Authority: | United States: Federal Government |
embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma pleomorphic childhood rhabdomyosarcoma mixed childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma nonmetastatic childhood soft tissue sarcoma childhood fibrosarcoma childhood synovial sarcoma childhood malignant hemangiopericytoma childhood liposarcoma |
childhood alveolar soft-part sarcoma childhood leiomyosarcoma childhood neurofibrosarcoma childhood angiosarcoma childhood epithelioid sarcoma childhood malignant fibrous histiocytoma of bone childhood malignant mesenchymoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor localized Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Histiocytoma, Malignant Fibrous Fibrosarcoma Neuroectodermal Tumors, Primitive Histiocytoma, Benign Fibrous Leiomyosarcoma Epithelioid sarcoma Malignant mesenchymal tumor Ewing's family of tumors Alveolar soft part sarcoma Cyclophosphamide Etoposide phosphate Soft tissue sarcomas Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's |
Ewing's sarcoma Dactinomycin Neuroepithelioma Sarcoma, Alveolar Soft Part Etoposide Desmoplastic small round cell tumor Rhabdomyosarcoma Synovial sarcoma Vincristine Carboplatin Hemangiosarcoma Epirubicin Hemangiopericytoma Neuroectodermal Tumors Ifosfamide |
Neoplasms, Muscle Tissue Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Anti-Bacterial Agents Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Myosarcoma Mitosis Modulators |
Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Neoplasms, Connective Tissue Antineoplastic Agents, Alkylating Neoplasms, Fibrous Tissue Antirheumatic Agents Antineoplastic Agents, Phytogenic |