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

Primary Purpose

Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
dactinomycin
cyclophosphamide
vincristine sulfate
radiation therapy
Sponsored by
Japan Rhabdomyosarcoma Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Anjo Kosei HosptialRecruiting
  • Aichi Medical UniversityRecruiting
  • National Hospital Orgnization Nagoya Medical CenterRecruiting
  • Ehime Prefectural Central HospitalRecruiting
  • National Kyushu Cancer CenterRecruiting
  • Kurume University School of MedicineRecruiting
  • Gifu Municipal HospitalRecruiting
  • Gunma Children's Medical CenterRecruiting
  • National Hospital Organization - Medical Center of KureRecruiting
  • Sapporo Medical UniversityRecruiting
  • Hokkaido University Graduate School of MedicineRecruiting
  • Kobe City General HospitalRecruiting
  • Ibaraki Children's HospitalRecruiting
  • University of TsukubaRecruiting
  • Ishikawa Prefectural Central HospitalRecruiting
  • Kanazawa Medical UniversityRecruiting
  • Kagoshima City HospitalRecruiting
  • National Center for Child Health and DevelopmentRecruiting
  • Showa University Fujigaoka HospitalRecruiting
  • Yokohama City UniversityRecruiting
  • Miyazaki Medical College University of MiyazakiRecruiting
  • Nagano Children's HospitalRecruiting
  • Osaka Medical Center and Research Institute for Maternal and Child HealthRecruiting
  • Osaka City General HospitalRecruiting
  • Osaka University Graduate School of MedicineRecruiting
  • Osaka Medical CollegeRecruiting
  • Dokkyo University School of MedicineRecruiting
  • National Defense Medical CollegeRecruiting
  • Shiga University of Medical ScienceRecruiting
  • Shimane Prefectural Central HospitalRecruiting
  • Shimane University HospitalRecruiting
  • Seirei Hamamatsu General HospitalRecruiting
  • Tokyo Metropolitan Kiyose Children's HospitalRecruiting
  • Fukushima Medical University HospitalRecruiting
  • Gifu University Graduate School of MedicineRecruiting
  • Hiroshima University HospitalRecruiting
  • Kagoshima UniversityRecruiting
  • Kyoto Prefectural University of MedicineRecruiting
  • Kyoto University HospitalRecruiting
  • Osaka City UniversityRecruiting
  • Osaka General Medical CenterRecruiting
  • Saitama Children's Medical CenterRecruiting
  • Hokkaido Medical Center for Child Health and RehabilitationRecruiting
  • National Cancer Center HospitalRecruiting
  • St. Luke's International HospitalRecruiting
  • Tokyo Medical and Dental UniversityRecruiting
  • Toho University School of MedicineRecruiting
  • Keio University School of MedicineRecruiting
  • Nihon University Itabashi HospitalRecruiting
  • Toyama University HospitalRecruiting
  • Yamagata University HospitalRecruiting

Outcomes

Primary Outcome Measures

Disease-free survival as measured by Kaplan-Meier method 3 years after study entry

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2005
Last Updated
August 9, 2013
Sponsor
Japan Rhabdomyosarcoma Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00245141
Brief Title
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Official Title
Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Rhabdomyosarcoma Study Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
dactinomycin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
Secondary Outcome Measure Information:
Title
Overall survival as measured by Kaplan-Meier method 3 years after study entry
Title
Progression-free survival as measured by Kaplan-Meier method during events
Title
Complete response rate (orbit, group III only) at completion of study treatment
Title
Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hajime Hosoi
Organizational Affiliation
Kyoto Prefectural University of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Masa-aki Kumagai, MD
Organizational Affiliation
National Center for Child Health and Development
Facility Information:
Facility Name
Anjo Kosei Hosptial
City
Anjo
State/Province
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Miyajima, MD
Phone
81-566-75-2111
Email
miyajima@kosei.anjo.aichi
Facility Name
Aichi Medical University
City
Nagakuti
State/Province
Aichi
ZIP/Postal Code
480-1103
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshinori Hori
Phone
81-561-62-3311
Facility Name
National Hospital Orgnization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keizo Horibe, MD, PhD
Phone
81-52-951-1111
Email
horibek@nnh.hosp.go.jp
Facility Name
Ehime Prefectural Central Hospital
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otoh Yoshiko
Phone
81-89-947-1111
Facility Name
National Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryohei Yokoyama, MD
Phone
81-92-541-3231 ext. 5070
Email
ryokoya@nk-cc.go.jp
Facility Name
Kurume University School of Medicine
City
Kurume City
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroko Inada
Phone
81-942-31-7565
Facility Name
Gifu Municipal Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Takao, MD
Phone
81-58-251-1101
Email
oyuki@gmhosp.gifu.gifu.jp
Facility Name
Gunma Children's Medical Center
City
Seta-gun
State/Province
Gunma
ZIP/Postal Code
377-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manabu Sotomatsu, MD
Phone
81-279-52-3551
Email
sotomatsu@gcmc.pref.gunma.jp
Facility Name
National Hospital Organization - Medical Center of Kure
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeo Tanaka, MD, PhD
Phone
81-82-322-3111
Facility Name
Sapporo Medical University
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8556
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Suzuki, MD, PhD
Phone
81-11-611-2111
Facility Name
Hokkaido University Graduate School of Medicine
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryoji Kobayashi, MD
Phone
81-11-706-5954
Facility Name
Kobe City General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ikuya Usami
Phone
81-78-302-4321
Facility Name
Ibaraki Children's Hospital
City
Mito-shi
State/Province
Ibaraki
ZIP/Postal Code
311-4145
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazutoshi Koike
Phone
81-29-254-1151
Email
kazukoike@ibaraki-kodomo.com
Facility Name
University of Tsukuba
City
Tsukuba-city
State/Province
Ibaraki
ZIP/Postal Code
305-8575
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michio Kaneko, MD, PhD
Phone
81-29-853-3094
Email
mkaneko@md.tsukuba.ac.jp
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-02
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seiki Horita
Phone
81-76-237-8211
Email
shorita@ipch.jp
Facility Name
Kanazawa Medical University
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutaka Saikawa, MD, PhD
Phone
81-76-265-2314
Email
saikawa@ped.m.kanazawa-u.ac.jp
Facility Name
Kagoshima City Hospital
City
Kagoshima City
State/Province
Kagoshima
ZIP/Postal Code
892-8580
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Kawakami
Phone
81-99-224-2101
Facility Name
National Center for Child Health and Development
City
Tokyo
State/Province
Kanagawa
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masa-aki Kumagai, MD
Phone
81-3-3416-0181
Email
kumagai-ma@ncchd.go.jp
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
227-8502
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Isoyama
Phone
81-45-971-1151
Email
isoyama@syowa-univesity-fujigaoka.gr.jp
Facility Name
Yokohama City University
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Goto
Phone
81-45-787-2800
Facility Name
Miyazaki Medical College University of Miyazaki
City
Miyazaki-gun
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Moritake
Phone
81-98-585-0989
Facility Name
Nagano Children's Hospital
City
Toyoshina-machi
State/Province
Nagano
ZIP/Postal Code
399-8288
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eizaburo Ishii
Phone
81-263-73-6700
Facility Name
Osaka Medical Center and Research Institute for Maternal and Child Health
City
Izumi
State/Province
Osaka
ZIP/Postal Code
594-1101
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keisei Kawa, MD, PhD
Phone
81-725-56-1220
Email
kawakei@mch.pref.osaka.jp
Facility Name
Osaka City General Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junichi Hara
Phone
81-6-6929-1221
Facility Name
Osaka University Graduate School of Medicine
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideaki Ohta, MD, PhD
Phone
81-6-6879-3937
Email
ohta@ped.med.osaka-u.ac.jp
Facility Name
Osaka Medical College
City
Takatsuki City
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomoko Kuno
Phone
81-72-683-1221
Facility Name
Dokkyo University School of Medicine
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hitoshi Ikeda, MD
Phone
81-489-65-1111
Email
hike@dokkyomed.ac.jp
Facility Name
National Defense Medical College
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuhiro Kogawa
Phone
81-4-2995-1621
Facility Name
Shiga University of Medical Science
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-21
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeru Ohta, MD
Phone
81-775-48-2228
Email
ohta@belle.shiga-med.ac.jp
Facility Name
Shimane Prefectural Central Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-0068
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Taketani, MD
Phone
81-853-20-2219
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Taketani, MD
Phone
81-853-20-2219
Email
ttaketani@med.shimane-u.ac.jp
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tadashi Matsubayashi
Phone
81-53-474-2222
Facility Name
Tokyo Metropolitan Kiyose Children's Hospital
City
Kiyosei
State/Province
Tokyo
ZIP/Postal Code
204-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Kaneko, MD
Phone
81-424-91-0011
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Kikuta, MD
Phone
81-24-547-1295
Facility Name
Gifu University Graduate School of Medicine
City
Gifu
ZIP/Postal Code
500-8705
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Kaneko
Phone
81-58-230-6386
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nishimura Shinichiro, MD
Phone
81-82-257-5212
Facility Name
Kagoshima University
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshifumi Kawano
Phone
81-99-275-5351
Email
ykawano@m3.kufm.kagoshima-u.ac.jp
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajime Hosoi
Phone
81-75-251-5571
Email
hhosoi@koto.kpu-m.ac.jp
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenichiro Watanabe, MD
Phone
81-75-751-3297
Email
wataken@kuhp.kyoto-u.ac.jp
Facility Name
Osaka City University
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazumi Yamato
Phone
81-6-6645-3175
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-0056
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keiko Yumura-Yagi, MD
Phone
81-6-6692-1201
Facility Name
Saitama Children's Medical Center
City
Saitama
ZIP/Postal Code
339-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Kikuchi, MD, PhD
Phone
81-48-758-1811
Email
a1091069@pref.saitama.jp
Facility Name
Hokkaido Medical Center for Child Health and Rehabilitation
City
Sapporo
ZIP/Postal Code
006-0041
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tooru Kudoh, MD, PhD
Phone
81-11-691-5696
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Makimoto
Phone
81-3-3542-2511
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. Hosoya, MD
Phone
81-3-3541-5151
Facility Name
Tokyo Medical and Dental University
City
Tokyo
ZIP/Postal Code
113-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masayuki Nagasawa
Phone
81-3-5803-5246
Facility Name
Toho University School of Medicine
City
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Ohara
Phone
81-3-3762-4151
Facility Name
Keio University School of Medicine
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhide Morikawa, MD
Phone
81-3-5363-2593
Email
ymorikaw@sc.itc.keio.ac.jp
Facility Name
Nihon University Itabashi Hospital
City
Tokyo
ZIP/Postal Code
173
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Mugishima, MD
Phone
81-3-3972-8111 ext. 2700
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirokazu Kanegane
Phone
81-76-434-7313
Email
kanegane@ms.toyama-mpu.ac.jp
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitsui Tetsuo, MD, DMedSci
Phone
81-23-628-5329
Email
tmitsui@med.id.yamagata-u.ac.jp

12. IPD Sharing Statement

Learn more about this trial

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

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