Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00245141
- Lead Sponsor
- Japan Rhabdomyosarcoma Study Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
- Secondary Outcome Measures
Name Time Method Overall survival as measured by Kaplan-Meier method 3 years after study entry Progression-free survival as measured by Kaplan-Meier method during events Complete response rate (orbit, group III only) at completion of study treatment Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry
Trial Locations
- Locations (51)
Anjo Kosei Hosptial
🇯🇵Anjo, Aichi, Japan
Aichi Medical University
🇯🇵Nagakuti, Aichi, Japan
National Hospital Orgnization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kurume University School of Medicine
🇯🇵Kurume City, Fukuoka, Japan
Gifu Municipal Hospital
🇯🇵Gifu-shi, Gifu, Japan
Gunma Children's Medical Center
🇯🇵Seta-gun, Gunma, Japan
National Hospital Organization - Medical Center of Kure
🇯🇵Kure, Hiroshima, Japan
Sapporo Medical University
🇯🇵Sapporo, Hokkaido, Japan
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