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