Randomized study of vincristine, dactinomycin and cyclophosphamide (VAC) versus VAC alternating with vincristine and irinotecan (VI) for patients with intermediate-risk rhabdomyosarcoma (RMS)

eagle-i ID

Resource Type

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1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00354835?term=A+Phase+III+Randomized+Study+of+Vincristine%2C+Dactinomycin+and+Cyclophosphamide+%28VAC%29+versus+VAC+Alternating+with+Vincristine+and+Irinotecan+%28VI%29+for+patients+with+Intermediate-Risk+Rhabdomyosarcoma+%28RMS%29.&rank=1

2. Intervention

   Tumor resection

3. Intervention

   Radiation therapy

4. Resource Description

   Rhabdomyosarcoma is the most common soft tissue sarcoma in children and adolescents, accounting for nearly 250 cases of childhood cancer in the United States each year. Despite the use of multiple drug therapies, only 65% of intermediate-risk patients are expected to be cured. The overall goal of this study is to see if we can increase this cure rate without causing more serious side effects of treatment. Researchers want to know if they can improve the cure rate for Intermediate-Risk Rhabdomyosarcoma by treating with surgery to remove as much tumor as possible, radiation therapy and chemotherapy. Participants in the study will receive one of two different treatment plans. Another goal of this study is to compare a new schedule of giving radiation therapy at week 4 compared to the standard schedule of starting at week 13. Other studies of radiation timing for other cancers have shown improved outcomes when radiation was given earlier in the treatment plan. A slightly lower dose of cyclophosphamide will also be given to compare side effects of the higher standard dose.

5. Contact

   Berenberg, Jeffrey

6. PI

   Wilkinson, Robert, M.D.

7. Topic

   rhabdomyosarcoma

8. Study Population

   Patients younger than 50 years old who are newly diagnosed with intermediate-risk rhabdomyosarcoma, either embryonal or alveolar.

9. Funded by

   Children's Oncology Group

10. Phase

    Phase 3 clinical trial

11. Performed by

    Clinical Protocol & Data Management Shared Resource