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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000453316 | Registry Identifier | PDQ (Physician Data Query) |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dactinomycin | Biological | |||
| cyclophosphamide | Drug | |||
| vincristine sulfate | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival as measured by Kaplan-Meier method 3 years after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival as measured by Kaplan-Meier method 3 years after study entry | ||
| Progression-free survival as measured by Kaplan-Meier method during events | ||
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DISEASE CHARACTERISTICS:
Diagnosis of embryonal rhabdomyosarcoma
Primary operation for pathological diagnosis within the past 42 days
The following variants are eligible:
Meets 1 of the following stage criteria:
Stage I, clinical group I or II (N0), defined by all of the following criteria:
Stage I, clinical group III (N0), defined by all of the following criteria:
Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Other
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| Name | Affiliation | Role |
|---|---|---|
| Hajime Hosoi | Kyoto Prefectural University of Medicine | Study Chair |
| Masa-aki Kumagai, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo Kosei Hosptial | Recruiting | Anjo | Aichi-ken | 446-8602 | Japan |
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| 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 |
| Aichi Medical University | Recruiting | Nagakuti | Aichi-ken | 480-1103 | Japan |
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| National Hospital Orgnization Nagoya Medical Center | Recruiting | Nagoya | Aichi-ken | 460-0001 | Japan |
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| Ehime Prefectural Central Hospital | Recruiting | Matsuyama | Ehime | 790-0024 | Japan |
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| National Kyushu Cancer Center | Recruiting | Fukuoka | Fukuoka | 811-1395 | Japan |
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| Kurume University School of Medicine | Recruiting | Kurume | Fukuoka | 830-0011 | Japan |
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| Fukushima Medical University Hospital | Recruiting | Fukushima | Fukushima | 960-1295 | Japan |
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| Gifu Municipal Hospital | Recruiting | Gifu | Gifu | 500-8513 | Japan |
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| Gifu University Graduate School of Medicine | Recruiting | Gifu | Gifu | 500-8705 | Japan |
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| Gunma Children's Medical Center | Recruiting | Seta-gun | Gunma | 377-8577 | Japan |
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| Hiroshima University Hospital | Recruiting | Hiroshima | Hiroshima | 734-8551 | Japan |
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| National Hospital Organization - Medical Center of Kure | Recruiting | Kure | Hiroshima | 737-0023 | Japan |
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| Sapporo Medical University | Recruiting | Sapporo | Hokkaido | 060-8556 | Japan |
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| Hokkaido University Graduate School of Medicine | Recruiting | Sapporo | Hokkaido | 060-8638 | Japan |
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| Kobe City General Hospital | Recruiting | Kobe | Hyōgo | 650 | Japan |
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| Ibaraki Children's Hospital | Recruiting | Mito | Ibaraki | 311-4145 | Japan |
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| University of Tsukuba | Recruiting | Tsukuba | Ibaraki | 305-8575 | Japan |
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| Ishikawa Prefectural Central Hospital | Recruiting | Kanazawa | Ishikawa-ken | 920-02 | Japan |
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| Kanazawa Medical University | Recruiting | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
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| Kagoshima University | Recruiting | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
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| Kagoshima City Hospital | Recruiting | Kagoshima | Kagoshima-ken | 892-8580 | Japan |
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| National Center for Child Health and Development | Recruiting | Tokyo | Kanagawa | 157-8535 | Japan |
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| Showa University Fujigaoka Hospital | Recruiting | Yokohama | Kanagawa | 227-8502 | Japan |
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| Yokohama City University | Recruiting | Yokohama | Kanagawa | 236-0004 | Japan |
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| Kyoto Prefectural University of Medicine | Recruiting | Kyoto | Kyoto | 602-8566 | Japan |
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| Kyoto University Hospital | Recruiting | Kyoto | Kyoto | 606-8507 | Japan |
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| Miyazaki Medical College University of Miyazaki | Recruiting | Miyazaki-gun | Miyazaki | 889-1692 | Japan |
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| Nagano Children's Hospital | Recruiting | Toyoshina-machi | Nagano | 399-8288 | Japan |
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| Osaka Medical Center and Research Institute for Maternal and Child Health | Recruiting | Izumi | Osaka | 594-1101 | Japan |
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| Osaka City University | Recruiting | Osaka | Osaka | 545-8586 | Japan |
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| Osaka General Medical Center | Recruiting | Osaka | Osaka | 558-0056 | Japan |
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| Osaka City General Hospital | Recruiting | Suita-shi | Osaka | 565-0871 | Japan |
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| Osaka University Graduate School of Medicine | Recruiting | Suita-shi | Osaka | 565-0871 | Japan |
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| Osaka Medical College | Recruiting | Takatsuki | Osaka | 569-8686 | Japan |
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| Dokkyo University School of Medicine | Recruiting | Koshigaya | Saitama | 343-8555 | Japan |
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| Saitama Children's Medical Center | Recruiting | Saitama | Saitama | 339-8551 | Japan |
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| National Defense Medical College | Recruiting | Tokorozawa | Saitama | 359-8513 | Japan |
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| Shiga University of Medical Science | Recruiting | Ōtsu | Shiga | 520-21 | Japan |
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| Shimane Prefectural Central Hospital | Recruiting | Izumo | Shimane | 693-0068 | Japan |
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| Shimane University Hospital | Recruiting | Izumo | Shimane | 693-8501 | Japan |
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| Seirei Hamamatsu General Hospital | Recruiting | Hamamatsu | Shizuoka | 430-8558 | Japan |
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| Tokyo Metropolitan Kiyose Children's Hospital | Recruiting | Kiyosei | Tokyo | 204-8567 | Japan |
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| National Cancer Center Hospital | Recruiting | Tokyo | Tokyo | 104-0045 | Japan |
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| St. Luke's International Hospital | Recruiting | Tokyo | Tokyo | 104 | Japan |
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| Tokyo Medical and Dental University | Recruiting | Tokyo | Tokyo | 113-8510 | Japan |
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| Toho University School of Medicine | Recruiting | Tokyo | Tokyo | 143-8541 | Japan |
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| Keio University School of Medicine | Recruiting | Tokyo | Tokyo | 160-8582 | Japan |
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| Nihon University Itabashi Hospital | Recruiting | Tokyo | Tokyo | 173 | Japan |
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| Toyama University Hospital | Recruiting | Toyama | Toyama | 930-0194 | Japan |
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| Yamagata University Hospital | Recruiting | Yamagata | Yamagata | 990-9585 | Japan |
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| Hokkaido Medical Center for Child Health and Rehabilitation | Recruiting | Sapporo | 006-0041 | Japan |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003609 | Dactinomycin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
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