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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003958 |
Purpose
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 |
|
Sarcoma |
Drug: cyclophosphamide Drug: dactinomycin Drug: filgrastim Drug: sargramostim Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: radiation therapy Procedure: surgical procedure |
Phase III |
| MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
| 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 |
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Show Detailed Description |
Eligibility
| 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:
Contacts and Locations![]() |
Show 233 Study Locations |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Carola A. S. Arndt, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Arndt CA, Hawkins DS, Stoner JA, et al.: Randomized phase III trial comparing vincristine, actinomycin, cyclophosphamide (VAC) with VAC/V topotecan/cyclophosphamide (TC) for intermediate risk rhabdomyosarcoma (IRRMS). D9803, COG study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9509, 528s, 2007.
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Arndt C, Hawkins D, Anderson JR, Breitfeld P, Womer R, Meyer W. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901. Erratum in: J Clin Oncol. 2004 Aug 15;22(16):3434. Correction of dosage error in text.
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| Study ID Numbers: | CDR0000067157, COG-D9803, CCG-D9803, POG-D9803, IRS-D9803 |
| First Received: | November 1, 1999 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003958 |
| Health Authority: | United States: Federal Government |
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