Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
Completed · Phase 3
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT00003958
- Run by
- Children's Oncology Group
- People needed
- 702
- Starts
- 2002-09-01
- Last updated by the study team
- 2013-06-17
Who can join
Age: any, up to 49. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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