Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
NCT ID: NCT00245141
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
32 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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dactinomycin
cyclophosphamide
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Spindle cell
* Anaplastic
* Meets 1 of the following stage criteria:
* Stage I, clinical group I or II (N0), defined by all of the following criteria:
* Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract
* Tumor any size
* Completely resected disease OR microscopic residual disease
* Lymph nodes clinically negative
* Stage I, clinical group III (N0), defined by all of the following criteria:
* Favorable site
* Tumor any size
* Gross residual disease allowed (orbit only)
* Lymph nodes clinically negative
* Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
* Unfavorable site (any sites not listed as favorable sites)
* Tumor ≤ 5 cm in diameter
* Completely resected disease
* Lymph nodes clinically negative OR lymph node involvement unknown
PATIENT CHARACTERISTICS:
Performance status
* 0-3
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 7.5 g/dL
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN
* Bile acid ≤ 2.5 times ULN
Renal
* Creatinine based on age as follows:
* \< 0.8 mg/dL (for patients \< 5 years of age)
* \< 1.2 mg/dL (for patients 5-9 years of age)
* \< 1.5 mg/dL (for patients ≥ 10 years of age)
Cardiovascular
* No severe heart disease
Other
* Not pregnant or nursing
* Must have acceptable organ function for age
* No uncontrolled infection
* No other active malignancy
* No other treated malignancy within the past 5 years
* No hypersensitivity to study drugs
* No Charcot-Marie-Tooth disease
* No chickenpox
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior anticancer chemotherapy
Endocrine therapy
* Prior anticancer steroids allowed
Radiotherapy
* No prior radiotherapy
Other
* No concurrent pentostatin
17 Years
ALL
No
Sponsors
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Japan Rhabdomyosarcoma Study Group
OTHER
Principal Investigators
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Hajime Hosoi
Role: STUDY_CHAIR
Kyoto Prefectural University of Medicine
Masa-aki Kumagai, MD
Role:
National Center for Child Health and Development
Locations
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Anjo Kosei Hosptial
Anjo, Aichi-ken, Japan
Aichi Medical University
Nagakuti, Aichi-ken, Japan
National Hospital Orgnization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan
National Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Kurume University School of Medicine
Kurume, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gifu Municipal Hospital
Gifu, Gifu, Japan
Gifu University Graduate School of Medicine
Gifu, Gifu, Japan
Gunma Children's Medical Center
Seta-gun, Gunma, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization - Medical Center of Kure
Kure, Hiroshima, Japan
Sapporo Medical University
Sapporo, Hokkaido, Japan
Hokkaido University Graduate School of Medicine
Sapporo, Hokkaido, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
Ibaraki Children's Hospital
Mito, Ibaraki, Japan
University of Tsukuba
Tsukuba, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Kanazawa Medical University
Kanazawa, Ishikawa-ken, Japan
Kagoshima University
Kagoshima, Kagoshima-ken, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, Japan
National Center for Child Health and Development
Tokyo, Kanagawa, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, Japan
Yokohama City University
Yokohama, Kanagawa, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Miyazaki Medical College University of Miyazaki
Miyazaki-gun, Miyazaki, Japan
Nagano Children's Hospital
Toyoshina-machi, Nagano, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan
Osaka City University
Osaka, Osaka, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Osaka City General Hospital
Suita-shi, Osaka, Japan
Osaka University Graduate School of Medicine
Suita-shi, Osaka, Japan
Osaka Medical College
Takatsuki, Osaka, Japan
Dokkyo University School of Medicine
Koshigaya, Saitama, Japan
Saitama Children's Medical Center
Saitama, Saitama, Japan
National Defense Medical College
Tokorozawa, Saitama, Japan
Shiga University of Medical Science
Ōtsu, Shiga, Japan
Shimane Prefectural Central Hospital
Izumo, Shimane, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Tokyo Metropolitan Kiyose Children's Hospital
Kiyosei, Tokyo, Japan
National Cancer Center Hospital
Tokyo, Tokyo, Japan
St. Luke's International Hospital
Tokyo, Tokyo, Japan
Tokyo Medical and Dental University
Tokyo, Tokyo, Japan
Toho University School of Medicine
Tokyo, Tokyo, Japan
Keio University School of Medicine
Tokyo, Tokyo, Japan
Nihon University Itabashi Hospital
Tokyo, Tokyo, Japan
Toyama University Hospital
Toyama, Toyama, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Hokkaido Medical Center for Child Health and Rehabilitation
Sapporo, , Japan
Countries
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Facility Contacts
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Yuji Miyajima, MD
Role: primary
Toshinori Hori
Role: primary
Keizo Horibe, MD, PhD
Role: primary
Otoh Yoshiko
Role: primary
Ryohei Yokoyama, MD
Role: primary
Hiroko Inada
Role: primary
Atsushi Kikuta, MD
Role: primary
Akira Takao, MD
Role: primary
Hideo Kaneko
Role: primary
Manabu Sotomatsu, MD
Role: primary
Nishimura Shinichiro, MD
Role: primary
Takeo Tanaka, MD, PhD
Role: primary
Nobuhiro Suzuki, MD, PhD
Role: primary
Ryoji Kobayashi, MD
Role: primary
Ikuya Usami
Role: primary
Kazutoshi Koike
Role: primary
Michio Kaneko, MD, PhD
Role: primary
Seiki Horita
Role: primary
Yutaka Saikawa, MD, PhD
Role: primary
Yoshifumi Kawano
Role: primary
Kiyoshi Kawakami
Role: primary
Masa-aki Kumagai, MD
Role: primary
K. Isoyama
Role: primary
Hiroaki Goto
Role: primary
Hajime Hosoi
Role: primary
Kenichiro Watanabe, MD
Role: primary
Hiroshi Moritake
Role: primary
Eizaburo Ishii
Role: primary
Keisei Kawa, MD, PhD
Role: primary
Kazumi Yamato
Role: primary
Keiko Yumura-Yagi, MD
Role: primary
Junichi Hara
Role: primary
Hideaki Ohta, MD, PhD
Role: primary
Tomoko Kuno
Role: primary
Hitoshi Ikeda, MD
Role: primary
Akira Kikuchi, MD, PhD
Role: primary
Kazuhiro Kogawa
Role: primary
Shigeru Ohta, MD
Role: primary
Ken Taketani, MD
Role: primary
Ken Taketani, MD
Role: primary
Tadashi Matsubayashi
Role: primary
Takashi Kaneko, MD
Role: primary
Atsushi Makimoto
Role: primary
R. Hosoya, MD
Role: primary
Masayuki Nagasawa
Role: primary
Akira Ohara
Role: primary
Yasuhide Morikawa, MD
Role: primary
Hideo Mugishima, MD
Role: primary
Hirokazu Kanegane
Role: primary
Mitsui Tetsuo, MD, DMedSci
Role: primary
Tooru Kudoh, MD, PhD
Role: primary
Other Identifiers
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CDR0000453316
Identifier Type: REGISTRY
Identifier Source: secondary_id
JRSG-UHA-PED03-01
Identifier Type: -
Identifier Source: org_study_id