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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003958 |
RATIONALE: Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.
PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Biological: dactinomycin Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: surgical procedure Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate-Risk Rhabdomyosarcoma |
Estimated Enrollment: | 518 |
Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (embryonal histology, stage II or III, Clinical Group III vs embryonal histology, Clinical Group IV, less than 10 years of age vs alveolar or undifferentiated sarcoma histology, stage I, Clinical Group I vs alveolar or undifferentiated sarcoma histology, stage II or III, Clinical Group II or III). Patients are randomized to 1 of 2 treatment arms.
Patients with Clinical Group II parameningeal tumors and Clinical Group III parameningeal tumors with base of skull erosion and/or cranial nerve palsy without evidence of intracranial extension receive radiotherapy on week 12 (day 84) or immediately thereafter.
Patients with Clinical Group IV parameningeal tumors with distant metastases receive radiotherapy to the primary site on week 12 (day 84). Patients with distant metastases confined to one site may receive radiotherapy to the metastatic site concurrently with therapy to the primary site if it began within 2 weeks of the initiation of chemotherapy (day 0).
Patients are followed every 1-2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 518 patients will be accrued for this study within 5 years.
Ages Eligible for Study: | up to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven disease of any of the following types:
Nonmetastatic alveolar rhabdomyosarcoma
Stage II or III, Clinical Group III embryonal rhabdomyosarcoma
Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma
Undifferentiated sarcoma
Ectomesenchymoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Carola A. S. Arndt, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067157, COG-D9803, CCG-D9803, POG-D9803, IRS-D9803 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003958 History of Changes |
Health Authority: | United States: Federal Government |
embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma nonmetastatic childhood soft tissue sarcoma childhood malignant mesenchymoma previously untreated childhood rhabdomyosarcoma |
adult rhabdomyosarcoma adult malignant mesenchymoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage I adult soft tissue sarcoma |
Immunologic Factors Vincristine Rhabdomyosarcoma, Childhood Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Malignant Mesenchymal Tumor Soft Tissue Sarcomas |
Dactinomycin Tubulin Modulators Sarcoma Antineoplastic Agents, Alkylating Antirheumatic Agents Topotecan Antineoplastic Agents, Phytogenic Alkylating Agents Rhabdomyosarcoma |
Neoplasms, Muscle Tissue Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Dactinomycin Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors Rhabdomyosarcoma |
Neoplasms by Histologic Type Myosarcoma Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Sarcoma Antineoplastic Agents, Alkylating Topotecan |