CClinicalTrials.gg
Status unknownNCT00245141Updated Aug 12, 2013

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

A Phase 2 interventional study of dactinomycin and cyclophosphamide in Sarcoma, sponsored by Japan Rhabdomyosarcoma Study Group. Status unknown at 51 sites in Japan. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2013-08-12.

Sponsored by Japan Rhabdomyosarcoma Study Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
32
Ages
Up to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcoma

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Keywords

  • embryonal childhood rhabdomyosarcoma
  • embryonal-botryoid childhood rhabdomyosarcoma
  • previously untreated childhood rhabdomyosarcoma
03

In context

Rhabdomyosarcoma

238 studies on the registry are indexed under Rhabdomyosarcoma; 47 are open to participants now.

This study's planned enrollment of 32 is below the median of 40 across 191 interventional studies indexed under Rhabdomyosarcoma.

Browse Rhabdomyosarcoma studies →

Lead sponsor

Japan Rhabdomyosarcoma Study Group is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
32 participants (estimated)

Interventions

  • Biologicaldactinomycin
  • Drugcyclophosphamide
  • Drugvincristine sulfate
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Overall survival as measured by Kaplan-Meier method 3 years after study entry

  2. Progression-free survival as measured by Kaplan-Meier method during events

  3. Complete response rate (orbit, group III only) at completion of study treatment

  4. Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry

07

Study locations

51 of 51 sites recruiting
  • Anjo Kosei Hosptial
    Anjo, Aichi 446-8602, Japan
    Recruiting
  • Aichi Medical University
    Nagakuti, Aichi 480-1103, Japan
    • Toshinori Hori · Contact · 81-561-62-3311
    Recruiting
  • National Hospital Orgnization Nagoya Medical Center
    Nagoya, Aichi 460-0001, Japan
    Recruiting
  • Ehime Prefectural Central Hospital
    Matsuyama-shi, Ehime 790-0024, Japan
    • Otoh Yoshiko · Contact · 81-89-947-1111
    Recruiting
  • National Kyushu Cancer Center
    Fukuoka-shi, Fukuoka 811-1395, Japan
    Recruiting
  • Kurume University School of Medicine
    Kurume City, Fukuoka 830-0011, Japan
    • Hiroko Inada · Contact · 81-942-31-7565
    Recruiting
  • Gifu Municipal Hospital
    Gifu-shi, Gifu 500-8513, Japan
    Recruiting
  • Gunma Children's Medical Center
    Seta-gun, Gunma 377-8577, Japan
    Recruiting
  • National Hospital Organization - Medical Center of Kure
    Kure, Hiroshima 737-0023, Japan
    • Takeo Tanaka, MD, PhD · Contact · 81-82-322-3111
    Recruiting
  • Sapporo Medical University
    Sapporo, Hokkaido 060-8556, Japan
    • Nobuhiro Suzuki, MD, PhD · Contact · 81-11-611-2111
    Recruiting
  • Hokkaido University Graduate School of Medicine
    Sapporo, Hokkaido 060-8638, Japan
    • Ryoji Kobayashi, MD · Contact · 81-11-706-5954
    Recruiting
  • Kobe City General Hospital
    Kobe, Hyogo 650, Japan
    • Ikuya Usami · Contact · 81-78-302-4321
    Recruiting
  • Ibaraki Children's Hospital
    Mito-shi, Ibaraki 311-4145, Japan
    Recruiting
  • University of Tsukuba
    Tsukuba-city, Ibaraki 305-8575, Japan
    Recruiting
  • Ishikawa Prefectural Central Hospital
    Kanazawa-shi, Ishikawa 920-02, Japan
    Recruiting
  • Kanazawa Medical University
    Kanazawa, Ishikawa 920-8641, Japan
    Recruiting
  • Kagoshima City Hospital
    Kagoshima City, Kagoshima 892-8580, Japan
    • Kiyoshi Kawakami · Contact · 81-99-224-2101
    Recruiting
  • National Center for Child Health and Development
    Tokyo, Kanagawa 157-8535, Japan
    Recruiting
  • Showa University Fujigaoka Hospital
    Yokohama-shi, Kanagawa 227-8502, Japan
    Recruiting
  • Yokohama City University
    Yokohama, Kanagawa 236-0004, Japan
    • Hiroaki Goto · Contact · 81-45-787-2800
    Recruiting
  • Miyazaki Medical College University of Miyazaki
    Miyazaki-gun, Miyazaki 889-1692, Japan
    • Hiroshi Moritake · Contact · 81-98-585-0989
    Recruiting
  • Nagano Children's Hospital
    Toyoshina-machi, Nagano 399-8288, Japan
    • Eizaburo Ishii · Contact · 81-263-73-6700
    Recruiting
  • Osaka Medical Center and Research Institute for Maternal and Child Health
    Izumi, Osaka 594-1101, Japan
    Recruiting
  • Osaka City General Hospital
    Suita-shi, Osaka 565-0871, Japan
    • Junichi Hara · Contact · 81-6-6929-1221
    Recruiting
  • Osaka University Graduate School of Medicine
    Suita-shi, Osaka 565-0871, Japan
    Recruiting
  • Osaka Medical College
    Takatsuki City, Osaka 569-8686, Japan
    • Tomoko Kuno · Contact · 81-72-683-1221
    Recruiting
  • Dokkyo University School of Medicine
    Koshigaya, Saitama 343-8555, Japan
    Recruiting
  • National Defense Medical College
    Tokorozawa, Saitama 359-8513, Japan
    • Kazuhiro Kogawa · Contact · 81-4-2995-1621
    Recruiting
  • Shiga University of Medical Science
    Otsu-shi, Shiga 520-21, Japan
    Recruiting
  • Shimane Prefectural Central Hospital
    Izumo, Shimane 693-0068, Japan
    • Ken Taketani, MD · Contact · 81-853-20-2219
    Recruiting
  • Shimane University Hospital
    Izumo, Shimane 693-8501, Japan
    Recruiting
  • Seirei Hamamatsu General Hospital
    Hamamatsu, Shizuoka 430-8558, Japan
    • Tadashi Matsubayashi · Contact · 81-53-474-2222
    Recruiting
  • Tokyo Metropolitan Kiyose Children's Hospital
    Kiyosei, Tokyo 204-8567, Japan
    • Takashi Kaneko, MD · Contact · 81-424-91-0011
    Recruiting
  • Fukushima Medical University Hospital
    Fukushima, 960-1295, Japan
    • Atsushi Kikuta, MD · Contact · 81-24-547-1295
    Recruiting
  • Gifu University Graduate School of Medicine
    Gifu, 500-8705, Japan
    • Hideo Kaneko · Contact · 81-58-230-6386
    Recruiting
  • Hiroshima University Hospital
    Hiroshima, 734-8551, Japan
    • Nishimura Shinichiro, MD · Contact · 81-82-257-5212
    Recruiting
  • Kagoshima University
    Kagoshima, 890-8520, Japan
    Recruiting
  • Kyoto Prefectural University of Medicine
    Kyoto, 602-8566, Japan
    Recruiting
  • Kyoto University Hospital
    Kyoto, 606-8507, Japan
    Recruiting
  • Osaka City University
    Osaka, 545-8586, Japan
    • Kazumi Yamato · Contact · 81-6-6645-3175
    Recruiting
  • Osaka General Medical Center
    Osaka, 558-0056, Japan
    • Keiko Yumura-Yagi, MD · Contact · 81-6-6692-1201
    Recruiting
  • Saitama Children's Medical Center
    Saitama, 339-8551, Japan
    Recruiting
  • Hokkaido Medical Center for Child Health and Rehabilitation
    Sapporo, 006-0041, Japan
    • Tooru Kudoh, MD, PhD · Contact · 81-11-691-5696
    Recruiting
  • National Cancer Center Hospital
    Tokyo, 104-0045, Japan
    • Atsushi Makimoto · Contact · 81-3-3542-2511
    Recruiting
  • St. Luke's International Hospital
    Tokyo, 104, Japan
    • R. Hosoya, MD · Contact · 81-3-3541-5151
    Recruiting
  • Tokyo Medical and Dental University
    Tokyo, 113-8510, Japan
    • Masayuki Nagasawa · Contact · 81-3-5803-5246
    Recruiting
  • Toho University School of Medicine
    Tokyo, 143-8541, Japan
    • Akira Ohara · Contact · 81-3-3762-4151
    Recruiting
  • Keio University School of Medicine
    Tokyo, 160-8582, Japan
    Recruiting
  • Nihon University Itabashi Hospital
    Tokyo, 173, Japan
    • Hideo Mugishima, MD · Contact · 81-3-3972-8111 ext. 2700
    Recruiting
  • Toyama University Hospital
    Toyama, 930-0194, Japan
    Recruiting
  • Yamagata University Hospital
    Yamagata, 990-9585, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00245141
Lead sponsor
Japan Rhabdomyosarcoma Study Group
First posted
Oct 27, 2005
Start date
May 2004
Primary completion
Apr 2011 (estimated)
Last update
Aug 12, 2013

Study contacts

Hajime Hosoi
study chair · Kyoto Prefectural University of Medicine
Masa-aki Kumagai, MD
National Center for Child Health and Development
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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