Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00245089
- 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.
- Detailed Description
OBJECTIVES:
* Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide followed by vincristine and dactinomycin.
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival at 3 years after study registration
- Secondary Outcome Measures
Name Time Method Overall survival at 3 years after study registration Toxicity by NCI CTC at 3 years after study registration
Trial Locations
- Locations (48)
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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