ARST0531 - Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC alternating with Vincristine and Irinotecan Hydrochloride in Combination With Radiotherapy for Patients with Intermediate Risk Rhabdomyosarcoma( RMS)
ID Number 80-0066-00066Principal Investigator(s)
Department(s) or Division(s)
Rhabdomyosarcoma (RMS) is a type of cancer that occurs in the soft tissues of the body like the muscles.
The current standard treatment for rhabdomyosarcoma is surgery to remove as much tumor as possible, chemotherapy (anti-cancer drug therapy) with vincristine, dactinomycin and cyclophosphamide (together called VAC therapy), and, for almost all tumors, radiation therapy (treatment with high energy X-rays).
The study doctors would like to see if adding an additional drug combination (vincristine plus irinotecan, or VI) is better than VAC alone. The standard time for radiation therapy to start for most patients with RMS is about 13 weeks after beginning chemotherapy. The study doctors will be looking at the effectiveness of giving radiation therapy earlier in the course of treatment (at 4 weeks instead of 13 weeks). Finally, the study doctors would like to see if a lower dose of cyclophosphamide is as good for treating RMS as the standard dose, but with less toxicity during treatment and afterwards (late effects).
The overall purpose of the study is:
- to see if the new combination (VAC plus VI) is better than the standard chemotherapy (VAC) alone for treating intermediate risk RMS
- to compare the effects, good and/or bad, of a new combination (VAC plus VI) of chemotherapy
- to compare a new schedule (starting at Week 4) for giving radiation therapy to the standard schedule (starting at Week 13)
- to compare the side effects of a slightly lower dose of cyclophosphamide to the higher standard dose
Recruiting Patients: Yes