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
National Hospital Orgnization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Gunma Children's Medical Center
🇯🇵Seta-gun, Gunma, Japan
University of Tsukuba
🇯🇵Tsukuba-city, Ibaraki, Japan
National Center for Child Health and Development
🇯🇵Tokyo, Kanagawa, Japan
Osaka City General Hospital
🇯🇵Suita-shi, Osaka, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
🇯🇵Izumi, Osaka, Japan
Osaka Medical College
🇯🇵Takatsuki City, Osaka, Japan
Dokkyo University School of Medicine
🇯🇵Koshigaya, Saitama, Japan
Shiga University of Medical Science
🇯🇵Otsu-shi, Shiga, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Osaka City University
🇯🇵Osaka, Japan
Toho University School of Medicine
🇯🇵Tokyo, Japan
Keio University School of Medicine
🇯🇵Tokyo, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Yokohama City University
🇯🇵Yokohama, Kanagawa, Japan
Miyazaki Medical College University of Miyazaki
🇯🇵Miyazaki-gun, Miyazaki, Japan
Nagano Children's Hospital
🇯🇵Toyoshina-machi, Nagano, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Japan
Gifu University Graduate School of Medicine
🇯🇵Gifu, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
National Defense Medical College
🇯🇵Tokorozawa, Saitama, Japan
Saitama Children's Medical Center
🇯🇵Saitama, Japan
Aichi Medical University
🇯🇵Nagakuti, Aichi, Japan
Gifu Municipal Hospital
🇯🇵Gifu-shi, Gifu, Japan
Kurume University School of Medicine
🇯🇵Kurume City, Fukuoka, Japan
Hokkaido University Graduate School of Medicine
🇯🇵Sapporo, Hokkaido, Japan
Kagoshima City Hospital
🇯🇵Kagoshima City, Kagoshima, Japan
Osaka University Graduate School of Medicine
🇯🇵Suita-shi, Osaka, Japan
Tokyo Medical and Dental University
🇯🇵Tokyo, Japan
Kobe City General Hospital
🇯🇵Kobe, Hyogo, Japan
National Hospital Organization - Medical Center of Kure
🇯🇵Kure, Hiroshima, Japan
Shimane University Hospital
🇯🇵Izumo, Shimane, Japan
Kagoshima University
🇯🇵Kagoshima, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
Sapporo Medical University
🇯🇵Sapporo, Hokkaido, Japan
Ibaraki Children's Hospital
🇯🇵Mito-shi, Ibaraki, Japan
Kanazawa Medical University
🇯🇵Kanazawa, Ishikawa, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Hokkaido Medical Center for Child Health and Rehabilitation
🇯🇵Sapporo, Japan