Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
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ClinicalTrials.gov Identifier: NCT00003958 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 17, 2013
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Condition or disease | Intervention/treatment | Phase |
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Adult Malignant Mesenchymoma Adult Rhabdomyosarcoma Alveolar Childhood Rhabdomyosarcoma Childhood Malignant Mesenchymoma Embryonal Childhood Rhabdomyosarcoma Embryonal-botryoid Childhood Rhabdomyosarcoma Nonmetastatic Childhood Soft Tissue Sarcoma Previously Untreated Childhood Rhabdomyosarcoma Stage I Adult Soft Tissue Sarcoma Stage II Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma | Biological: dactinomycin Drug: vincristine sulfate Drug: cyclophosphamide Procedure: therapeutic conventional surgery Radiation: radiation therapy Drug: topotecan hydrochloride Biological: filgrastim Biological: sargramostim Other: laboratory biomarker analysis | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 702 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | October 2007 |

Arm | Intervention/treatment |
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Experimental: Arm I
Vincristine sulfate IV once a wk on wks 0-12, 15, 18-24, 27, 30-36, and 39. Dactinomycin IV once a wk on wks 0, 3, 6, 9, 12, 21, 24, 27, 30, 33, 36, and 39. Cyclophosphamide IV once a wk on wks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, and 39. After 12 weeks of chemotherapy, depending on tumor shrinkage, pts may undergo surgery. After recovery from therapeutic conventional surgery, patients receive radiation therapy once a day, 5 days a wk, during wks 12-18. For pt receiving radiotherapy during wks 0-6, dactinomycin is omitted during wks 3 and 6 and during wks 15 and 18. For patients receiving radiotherapy during wks 12-18, dactinomycin is omitted during wks 15 and 18. Patients with adequate response at wk 24 continue chemotherapy during wks 24-39. All pts receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.
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Biological: dactinomycin
Given IV
Other Names:
Drug: vincristine sulfate Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Procedure: therapeutic conventional surgery Undergo surgery Radiation: radiation therapy Undergo radiotherapy
Other Names:
Biological: filgrastim Given SC
Other Names:
Biological: sargramostim Given SC
Other Names:
Other: laboratory biomarker analysis Correlative studies |
Experimental: Arm II
Patients receive treatment as in arm I, except dactinomycin is replaced with topotecan hydrochloride IV over 15-30 minutes daily for 5 days during weeks 3, 9, 21, 27, 33, and 39. All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery. |
Drug: vincristine sulfate
Given IV
Other Names:
Drug: cyclophosphamide Given IV
Other Names:
Procedure: therapeutic conventional surgery Undergo surgery Radiation: radiation therapy Undergo radiotherapy
Other Names:
Drug: topotecan hydrochloride Given IV
Other Names:
Biological: filgrastim Given SC
Other Names:
Biological: sargramostim Given SC
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- Long-term failure-free survival (FFS) between the two treatment groups [ Time Frame: Up to 5 years ]
- Overall survival between treatments [ Time Frame: Up to 5 years ]
- Rate of second look surgery [ Time Frame: Week 12 ]
- Proportion of patients rendered tumor-free or with microscopic tumor only [ Time Frame: Week 12 ]
- Estimation of the rate of local failure for the patients who undergo second look surgery [ Time Frame: Week 12 ]Done using standard cumulative incidence curves.

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Ages Eligible for Study: | up to 49 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histologically proven disease of any of the following types:
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Non metastatic alveolar rhabdomyosarcoma
- Stage I, II, or III; Clinical Group I, II, or III
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Stage II or III, Clinical Group III embryonal rhabdomyosarcoma
- Botryoid
- Spindle cell
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Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma
- Botryoid
- Spindle cell
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Undifferentiated sarcoma
- Stage I, II, or III; Clinical Group I, II, or III
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Ectomesenchymoma
- Stage I, II, or III; Clinical Group I, II, or III, with alveolar features
- Under 10 years, Stage IV, Clinical Group IV, with embryonal features
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- No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis
- No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases
- Bilirubin no greater than 1.5 mg/dL
- Creatinine normal* for age
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior chemotherapy
- Prior steroids allowed
- No prior radiotherapy
- See Disease Characteristics

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003958
United States, California | |
Children's Oncology Group | |
Arcadia, California, United States, 91006-3776 |
Principal Investigator: | Carola Arndt | Children's Oncology Group |
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00003958 History of Changes |
Other Study ID Numbers: |
D9803 NCI-2012-02302 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) IRS-D9803 ( Other Identifier: Intergroup Rhabdosarcoma Group ) COG-D9803 ( Other Identifier: Children's Oncology Group ) POG-D9803 ( Other Identifier: Pediatric Oncology Group ) CDR0000067157 ( Other Identifier: Clinical Trials.gov ) CCG-D9803 ( Other Identifier: Children's Cancer Group ) U10CA098543 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 17, 2013 |
Last Verified: | June 2013 |
Sarcoma Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Mesenchymoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Complex and Mixed Dactinomycin Cyclophosphamide Vincristine Topotecan Lenograstim |
Sargramostim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Adjuvants, Immunologic |