Research

Rhabdomyosarcoma, Low-Risk Embryonal/Botryoid Treatment - Phase III

Vincristine, Dactinomycin and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid Rhabdomyosarcoma

Protocol Description

The purpose of this Children's Oncology Group Phase III study is to determine the most effective treatment with the least amount of therapy that will cure patients with low risk rhabdomyosarcoma. The standard treatment for rhabdomyosarcoma consists of chemotherapy, surgery, and/or radiation therapy. This study will employ alternate chemotherapy regimens to determine if the length of therapy can be shortened.

Eligibility Criteria

The group study accepts male and female candidates under age 50 who have been diagnosed with embryonal rhabdomyosarcoma or a related type called botryoid.
Boys: All ages
Girls: All ages

Requirements
Chemotherapy according to 1 of 2 treatment regimens, with participants having standard medical and organ function tests along with possible CT, MRI or bone scans throughout the study. Chemotherapy will be done with the recommended use of a central line.
Visits: Varies depending on regimen assignment
Duration: 24 weeks for Regimen A and 48 weeks for Regimen B, with participants followed for 10 years after

Status: Open for Enrollment

Source of Support
Children’s Oncology Group (Study ARST0331)
National Cancer Institute

Additional Resources
Children’s Oncology Group CureSearch
Study Description at National Institutes of Health