Vincristine, dactinomycin, and lower doses of cyclophosphamide with or without radiation therapy for patients with newly diagnosed low-risk embryonal/botryoid/spindle cell rhabdomyosarcoma

eagle-i ID

Resource Type

Properties

1. Intervention

   Vincristine

2. Intervention

   Dactinomycin

3. Intervention

   Cyclophosphamide

4. Intervention

   Radiation therapy

5. Additional Topic(s)

   Antineoplastic Combined Chemotherapy Protocols

6. Additional Topic(s)

   Radiotherapy

7. Resource Description

   Results of past research studies with low-risk rhabdomyosarcoma patients show that using the three chemotherapy medicines (including cyclophosphamide) helps to cure more patients, but cyclophosphamide at the high doses that were used in the past studies can cause late effects.This study is being done to find out the most effective treatment with the least amount of therapy that will still cure patients with low risk rhabdomyosarcoma.

8. Contact

   Berenberg, Jeffrey

9. PI

   Wilkinson, Robert, M.D.

10. Topic

    rhabdomyosarcoma

11. Study Population

    Patient Age: Patients must be < 50 years of age at the time of enrollment. The patient may be 50 years old if that birthday occurs during the period of rapid central review. For patients with: newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma. Enrollment on a biology study (COG D9902) to confirm the exact diagnosis is required for all patients.

12. Website(s)

    http://www.curesearch.org/ArticleView2.aspx?id=9112&l=8673

13. Funded by

    Children's Oncology Group

14. Phase

    Phase 3 clinical trial

15. Performed by

    Clinical Protocol & Data Management Shared Resource