Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Recruitment status was Recruiting
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma|
- Disease-free survival as measured by Kaplan-Meier method 3 years after study entry [ Designated as safety issue: No ]
- Overall survival as measured by Kaplan-Meier method 3 years after study entry [ Designated as safety issue: No ]
- Progression-free survival as measured by Kaplan-Meier method during events [ Designated as safety issue: No ]
- Complete response rate (orbit, group III only) at completion of study treatment [ Designated as safety issue: No ]
- Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
- Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
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|Study Chair:||Hajime Hosoi||Kyoto Prefectural University of Medicine|
|Investigator:||Masa-aki Kumagai, MD||National Center for Child Health and Development|