|Closed||Sarcoma; Solid Tumors||Phase III||
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.
|Ages Eligible for Study:||up to 50 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
Histologically or cytologically confirmed rhabdomyosarcoma (RMS)
- Must be concurrently enrolled on COG-D9902 to confirm local histologic diagnosis
Intermediate-risk disease, defined by 1 of the following surgicopathologic and staging criteria:
- Group III, stage 2 or 3 embryonal, botryoid, or spindle cell RMS
- Group III, stage 2 or 3 ectomesenchymoma
- Group I-III, stage 1-3 alveolar RMS
- Newly diagnosed disease
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
- Patients with extensive lymph node involvement, defined as ≥ 2 lymph nodes > 2 cm in dimension, identified by imaging studies, are not required to undergo SIRLND
- Regional lymph node sampling or sentinel lymph node procedure is required for histologic evaluation in patients with extremity tumors
- Has undergone initial surgery or biopsy within the past 42 days
- Must be able to undergo radiotherapy
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.