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Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003958
First received: November 1, 1999
Last updated: June 13, 2013
Last verified: June 2013
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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. 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.
| Condition | Intervention | Phase |
|---|---|---|
| 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 |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Long-term failure-free survival (FFS) between the two treatment groups [ Time Frame: Up to 5 years ]
Secondary Outcome Measures:
- 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.
| Enrollment: | 702 |
| Study Start Date: | September 2002 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 49 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Histologically proven disease of any of the following types:
-
Non metastatic alveolar rhabdomyosarcoma
- Stage I, II, or III; Clinical Group I, II, or III
-
Stage II or III, Clinical Group III embryonal rhabdomyosarcoma
- Botryoid
- Spindle cell
-
Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma
- Botryoid
- Spindle cell
-
Undifferentiated sarcoma
- Stage I, II, or III; Clinical Group I, II, or III
-
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
-
- 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
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003958
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003958
Locations
| United States, California | |
| Children's Oncology Group | |
| Arcadia, California, United States, 91006-3776 | |
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Carola Arndt | Children's Oncology Group |
More Information
| 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 ) |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 13, 2013 |
Additional relevant MeSH terms:
|
Sarcoma Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Mesenchymoma Liver Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Complex and Mixed Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Cyclophosphamide Vincristine Topotecan Dactinomycin Lenograstim 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 |
ClinicalTrials.gov processed this record on July 17, 2017