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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Anjo Kosei Hosptial
Anjo, Aichi-ken, Japan
RECRUITINGAichi Medical University
Nagakuti, Aichi-ken, Japan
RECRUITINGNational Hospital Orgnization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
RECRUITINGEhime Prefectural Central Hospital
Matsuyama, Ehime, Japan
Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
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
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National Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
RECRUITINGKurume University School of Medicine
Kurume, Fukuoka, Japan
RECRUITINGFukushima Medical University Hospital
Fukushima, Fukushima, Japan
RECRUITINGGifu Municipal Hospital
Gifu, Gifu, Japan
RECRUITINGGifu University Graduate School of Medicine
Gifu, Gifu, Japan
RECRUITINGGunma Children's Medical Center
Seta-gun, Gunma, Japan
RECRUITING...and 41 more locations