Trial Information

Summary: COG#ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS) - A Groupwide Phase III Study

You have/Your child has been asked to participate in this research study because you have/your child has a type of cancer called Rhabdomyosarcoma (RMS) (a type of cancer that occurs in the soft tissue of the body such as the muscles). Your/your child’s tumor is considered an intermediate risk tumor, which means there is a 35% (7 in 20) chance that your/your child’s tumor will return after treatment.  

The main purposes of this study are:

1)       To compare investigational treatment vincristine, actinomycin (also called dactinomycin) and cyclophosphamide (VAC) alternating with vincristine and irinotecan (VI) to standard chemotherapy (VAC alone) for treating intermediate risk RMS in terms of early response to treatment, survival and side effects.

2)       To compare an investigational schedule for giving radiation therapy (starting at Week 4) to the standard schedule (starting at Week 13).

3)       To compare the side effects of VAC as given on this study (using a slightly lower dose) to VAC as given on a previous study (using a higher standard dose).

4)       To see if changes in FDG PET scan (a type of imaging scan) from Week 1 to Week 4 to Week 15 reflects differences in survival.

5)       To see if genetic differences are related to the side effects subjects experience from treatment and to response to treatment.

You/Your child will receive treatment and active monitoring on this study for 43 weeks.  After treatment and active monitoring have been completed, your/your child’s medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: December 1, 2008 at 3:15:49 PM