Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

Basic Trial Information

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• Diagnosis of embryonal rhabdomyosarcoma
  • Primary operation for pathological diagnosis within the past 42 days
  • The following variants are eligible:
    • Botryoid
    • 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

Prior/Concurrent Therapy:

Chemotherapy

• No prior anticancer chemotherapy

Endocrine therapy

• Prior anticancer steroids allowed

Radiotherapy

• No prior radiotherapy

Other

• No concurrent pentostatin

Patient Characteristics:

Performance status

• 0-3

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 32 patients will be accrued for this study.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Japan Rhabdomyosarcoma Study Group

Hajime Hosoi, Protocol chair		Ph: 81-75-251-5571 Email: hhosoi@koto.kpu-m.ac.jp
Masa-aki Kumagai, MD, Protocol co-chair		Ph: 81-3-3416-0181 Email: kumagai-ma@ncchd.go.jp

Japan
	Sapporo
	Hokkaido Medical Center for Child Health and Rehabilitation
		Tooru Kudoh, MD, PhD	Ph:  81-11-691-5696
Aichi
	Anjo
	Anjo Kosei Hosptial
		Yuji Miyajima, MD	Ph:  81-566-75-2111
			Email: miyajima@kosei.anjo.aichi
	Nagakuti
	Aichi Medical University
		Toshinori Hori	Ph:  81-561-62-3311
	Nagoya
	National Hospital Orgnization Nagoya Medical Center
		Keizo Horibe, MD, PhD	Ph:  81-52-951-1111
			Email: horibek@nnh.hosp.go.jp
Ehime
	Matsuyama-shi
	Ehime Prefectural Central Hospital
		Otoh Yoshiko	Ph:  81-89-947-1111
Fukuoka
	Fukuoka-shi
	National Kyushu Cancer Center
		Ryohei Yokoyama, MD	Ph:  81-92-541-3231 ext. 5070
			Email: ryokoya@nk-cc.go.jp
	Kurume City
	Kurume University School of Medicine
		Hiroko Inada	Ph:  81-942-31-7565
Fukushima
	Fukushima
	Fukushima Medical University Hospital
		Atsushi Kikuta, MD	Ph:  81-24-547-1295
Gifu
	Gifu
	Gifu University Graduate School of Medicine
		Hideo Kaneko	Ph:  81-58-230-6386
	Gifu-shi
	Gifu Municipal Hospital
		Akira Takao, MD	Ph:  81-58-251-1101
			Email: oyuki@gmhosp.gifu.gifu.jp
Gunma
	Seta-gun
	Gunma Children's Medical Center
		Manabu Sotomatsu, MD	Ph:  81-279-52-3551
			Email: sotomatsu@gcmc.pref.gunma.jp
Hiroshima
	Hiroshima
	Hiroshima University Hospital
		Nishimura Shinichiro, MD	Ph:  81-82-257-5212
	Kure
	National Hospital Organization - Medical Center of Kure
		Takeo Tanaka, MD, PhD	Ph:  81-82-322-3111
Hokkaido
	Sapporo
	Hokkaido University Graduate School of Medicine
		Ryoji Kobayashi, MD	Ph:  81-11-706-5954
	Sapporo Medical University
		Nobuhiro Suzuki, MD, PhD	Ph:  81-11-611-2111
Hyogo
	Kobe
	Kobe City General Hospital
		Ikuya Usami	Ph:  81-78-302-4321
Ibaraki
	Mito-shi
	Ibaraki Children's Hospital
		Kazutoshi Koike	Ph:  81-29-254-1151
			Email: kazukoike@ibaraki-kodomo.com
	Tsukuba-city
	University of Tsukuba
		Michio Kaneko, MD, PhD	Ph:  81-29-853-3094
			Email: mkaneko@md.tsukuba.ac.jp
Ishikawa
	Kanazawa
	Kanazawa Medical University
		Yutaka Saikawa, MD, PhD	Ph:  81-76-265-2314
			Email: saikawa@ped.m.kanazawa-u.ac.jp
	Kanazawa-shi
	Ishikawa Prefectural Central Hospital
		Seiki Horita	Ph:  81-76-237-8211
			Email: shorita@ipch.jp
Kagoshima
	Kagoshima
	Kagoshima University
		Yoshifumi Kawano	Ph:  81-99-275-5351
			Email: ykawano@m3.kufm.kagoshima-u.ac.jp
	Kagoshima City
	Kagoshima City Hospital
		Kiyoshi Kawakami	Ph:  81-99-224-2101
Kanagawa
	Tokyo
	National Center for Child Health and Development
		Masa-aki Kumagai, MD	Ph:  81-3-3416-0181
			Email: kumagai-ma@ncchd.go.jp
	Yokohama
	Yokohama City University
		Hiroaki Goto	Ph:  81-45-787-2800
	Yokohama-shi
	Showa University Fujigaoka Hospital
		K. Isoyama	Ph:  81-45-971-1151
			Email: isoyama@syowa-univesity-fujigaoka.gr.jp
Kyoto
	Kyoto
	Kyoto Prefectural University of Medicine
		Hajime Hosoi	Ph:  81-75-251-5571
			Email: hhosoi@koto.kpu-m.ac.jp
	Kyoto University Hospital
		Kenichiro Watanabe, MD	Ph:  81-75-751-3297
			Email: wataken@kuhp.kyoto-u.ac.jp
Miyazaki
	Miyazaki-gun
	Miyazaki Medical College University of Miyazaki
		Hiroshi Moritake	Ph:  81-98-585-0989
Nagano
	Toyoshina-machi
	Nagano Children's Hospital
		Eizaburo Ishii	Ph:  81-263-73-6700
Osaka
	Izumi
	Osaka Medical Center and Research Institute for Maternal and Child Health
		Keisei Kawa, MD, PhD	Ph:  81-725-56-1220
			Email: kawakei@mch.pref.osaka.jp
	Osaka
	Osaka City University
		Kazumi Yamato	Ph:  81-6-6645-3175
	Osaka General Medical Center
		Keiko Yumura-Yagi, MD	Ph:  81-6-6692-1201
	Suita-shi
	Osaka City General Hospital
		Junichi Hara	Ph:  81-6-6929-1221
	Osaka University Graduate School of Medicine
		Hideaki Ohta, MD, PhD	Ph:  81-6-6879-3937
			Email: ohta@ped.med.osaka-u.ac.jp
	Takatsuki City
	Osaka Medical College
		Tomoko Kuno	Ph:  81-72-683-1221
Saitama
	Koshigaya
	Dokkyo University School of Medicine
		Hitoshi Ikeda, MD	Ph:  81-489-65-1111
			Email: hike@dokkyomed.ac.jp
	Saitama
	Saitama Children's Medical Center
		Akira Kikuchi, MD, PhD	Ph:  81-48-758-1811
			Email: a1091069@pref.saitama.jp
	Tokorozawa
	National Defense Medical College
		Kazuhiro Kogawa	Ph:  81-4-2995-1621
Shiga
	Otsu-shi
	Shiga University of Medical Science
		Shigeru Ohta, MD	Ph:  81-775-48-2228
			Email: ohta@belle.shiga-med.ac.jp
Shimane
	Izumo
	Shimane Prefectural Central Hospital
		Ken Taketani, MD	Ph:  81-853-20-2219
	Shimane University Hospital
		Ken Taketani, MD	Ph:  81-853-20-2219
			Email: ttaketani@med.shimane-u.ac.jp
Shizuoka
	Hamamatsu
	Seirei Hamamatsu General Hospital
		Tadashi Matsubayashi	Ph:  81-53-474-2222
Tokyo
	Kiyosei
	Tokyo Metropolitan Kiyose Children's Hospital
		Takashi Kaneko, MD	Ph:  81-424-91-0011
	Tokyo
	Keio University School of Medicine
		Yasuhide Morikawa, MD	Ph:  81-3-5363-2593
			Email: ymorikaw@sc.itc.keio.ac.jp
	National Cancer Center Hospital
		Atsushi Makimoto	Ph:  81-3-3542-2511
	Nihon University Itabashi Hospital
		Hideo Mugishima, MD	Ph:  81-3-3972-8111 ext. 2700
	St. Luke's International Hospital
		R. Hosoya, MD	Ph:  81-3-3541-5151
	Toho University School of Medicine
		Akira Ohara	Ph:  81-3-3762-4151
	Tokyo Medical and Dental University
		Masayuki Nagasawa	Ph:  81-3-5803-5246
Toyama
	Toyama
	Toyama University Hospital
		Hirokazu Kanegane	Ph:  81-76-434-7313
			Email: kanegane@ms.toyama-mpu.ac.jp
Yamagata
	Yamagata
	Yamagata University Hospital
		Mitsui Tetsuo, MD, DMedSci	Ph:  81-23-628-5329
			Email: tmitsui@med.id.yamagata-u.ac.jp

Registry Information
Official Title		Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients with Rhabdomyosarcoma
Trial Start Date		2004-05-01
Trial Completion Date		2011-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00245141
Date Submitted to PDQ		2005-09-13
Information Last Verified		2009-07-05

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