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Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
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
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

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Ifosfamide Cyclophosphamide Carboplatin Etoposide Vincristine sulfate Vincristine Etoposide phosphate Epirubicin hydrochloride Epirubicin Dactinomycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 400
Study Start Date: January 1995
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002898

Locations
United Kingdom, England
Institute of Child Health
Bristol, England, United Kingdom, BS2 8AE
Sponsors and Collaborators
Societe Internationale d'Oncologie Pediatrique
Investigators
Study Chair: M. C. G. Stevens, MD Institute of Child Health at University of Bristol
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009