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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: | NCT00354835 |
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, cyclophosphamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma.
Condition | Intervention | Phase |
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Sarcoma |
Drug: cyclophosphamide Drug: dactinomycin Drug: irinotecan hydrochloride Drug: vincristine sulfate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS) |
Estimated Enrollment: | 486 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (VAC): Active Comparator
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
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Drug: cyclophosphamide
Given IV over 1 hour
Drug: dactinomycin
Given IV over 1-5 minutes
Drug: vincristine sulfate
Given IV over 1 minute
Procedure: radiation therapy
Given 5 days a week for 4-6 weeks beginning in week 4
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Arm II (VAC/VI): Experimental
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.
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Drug: cyclophosphamide
Given IV over 1 hour
Drug: dactinomycin
Given IV over 1-5 minutes
Drug: irinotecan hydrochloride
Given IV over 1 hour
Drug: vincristine sulfate
Given IV over 1 minute
Procedure: radiation therapy
Given 5 days a week for 4-6 weeks beginning in week 4
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, historic control, randomized, multicenter study. Patients are stratified according to histology, disease stage, and clinical group (group III, stage 2 or 3 embryonal rhabdomyosarcoma [RMS] vs group I, stage 1 alveolar RMS vs group II or III, stage 2 or 3 alveolar RMS). Patients are randomized to 1 of 2 treatment arms. within 42 days of initial surgery or biopsy.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients* in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 (except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression).
NOTE: *Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients ≤ 24 months of age
After completion of study treatment, patients are followed periodically for ≥ 10 years.
PROJECTED ACCRUAL: A total of 486 patients will be accrued for this study.
Ages Eligible for Study: | up to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed rhabdomyosarcoma (RMS)
Intermediate-risk disease, defined by 1 of the following surgicopathologic and staging criteria:
Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) required for patients ≥ 10 years of age with paratesticular tumors and for patients < 10 years with clinically or radiographically involved lymph nodes
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Douglas Hawkins, MD | Children's Hospital and Regional Medical Center, Seattle |
Investigator: | Geoffrey McCowage, MD | Children's Hospital at Westmead |
Investigator: | Leo Mascarenhas, MD | Children's Hospital Los Angeles |
Study ID Numbers: | CDR0000487560, COG-ARST0531 |
Study First Received: | July 19, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00354835 |
Health Authority: | Unspecified |
alveolar childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma childhood malignant mesenchymoma adult rhabdomyosarcoma |
nonmetastatic childhood soft tissue sarcoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma adult malignant mesenchymoma |
Morphine Neoplasms, Connective and Soft Tissue Dactinomycin Malignant mesenchymal tumor Irinotecan Sarcoma |
Vincristine Cyclophosphamide Camptothecin Soft tissue sarcomas Rhabdomyosarcoma |
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 Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |