Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
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ClinicalTrials.gov Identifier: NCT00002898 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
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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 or disease | Intervention/treatment | 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 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Official Title: | MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood |
Study Start Date : | January 1995 |
Actual Study Completion Date : | December 2009 |


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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed primary soft tissue sarcoma:
- Rhabdomyosarcoma
- Non-rhabdomyosarcoma
- Soft tissue primitive neuroectodermal tumor (PNET)
- Extraosseous Ewing's sarcoma
PATIENT CHARACTERISTICS:
Age:
- Under 18
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic:
- Not specified
Chemotherapy:
- Not specified
Endocrine:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Prior primary surgery allowed
Other:
- No other prior therapy

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 ClinicalTrials.gov identifier (NCT number): NCT00002898
United Kingdom | |
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 |
Other Publications:
ClinicalTrials.gov Identifier: | NCT00002898 |
Other Study ID Numbers: |
CDR0000065228 SIOP-MMT-95 EU-96035 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | December 4, 2013 |
Last Verified: | May 1999 |
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 |
Sarcoma Rhabdomyosarcoma Histiocytoma Histiocytoma, Benign Fibrous Histiocytoma, Malignant Fibrous Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Dactinomycin Cyclophosphamide Ifosfamide |
Carboplatin Etoposide Vincristine Epirubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors |