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Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 1999 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002898
First received: November 1, 1999
Last updated: June 10, 2012
Last verified: May 1999
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: MMT 95 Study For Rhabdomyosarcoma and Other Malignant Soft Tissue Tumors of Childhood

Resource links provided by NLM:

U.S. FDA Resources

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
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

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

Publications:

ClinicalTrials.gov Identifier: NCT00002898     History of Changes
Other Study ID Numbers: CDR0000065228, SIOP-MMT-95, EU-96035
Study First Received: November 1, 1999
Last Updated: June 10, 2012
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

Additional relevant MeSH terms:
Histiocytoma
Fibrosis
Rhabdomyosarcoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Myosarcoma
Neoplasms, Muscle Tissue
Dactinomycin
 Epirubicin
Isophosphamide mustard
Cyclophosphamide
Etoposide
Ifosfamide
Vincristine
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013