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| Sponsored by: |
Societe Internationale d'Oncologie Pediatrique |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002898 |
Purpose
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 |
|---|---|---|
|
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: brachytherapy Radiation: 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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000065228, SIOP-MMT-95, EU-96035 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002898 History of Changes |
| 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 |
|
Fibrosarcoma Anti-Infective Agents Neuroectodermal Tumors, Primitive Histiocytoma, Benign Fibrous Sarcoma, Synovial Malignant Fibrous Histiocytoma Neoplasms, Connective and Soft Tissue Dactinomycin Neuroepithelioma Sarcoma, Alveolar Soft Part Etoposide Rhabdomyosarcoma Adjuvants, Immunologic Vincristine Carboplatin |
Ewing's Sarcoma Hemangiopericytoma Neuroectodermal Tumors Malignant Mesenchymal Tumor Liposarcoma Histiocytoma Sarcoma Antineoplastic Agents, Phytogenic Histiocytoma, Malignant Fibrous Desmoplastic Small Round Cell Tumor Immunologic Factors Leiomyosarcoma Cyclophosphamide Etoposide phosphate Anti-Bacterial Agents |
|
Anti-Infective Agents Neoplasms, Muscle Tissue Histiocytoma, Malignant Fibrous Immunologic Factors Molecular Mechanisms of Pharmacological Action Histiocytoma, Benign Fibrous Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Dactinomycin Therapeutic Uses Alkylating Agents |
Nucleic Acid Synthesis Inhibitors Rhabdomyosarcoma Neoplasms by Histologic Type Myosarcoma Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Epirubicin Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Ifosfamide |
