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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245141
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 27, 2005
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Sarcoma Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
Study Start Date : May 2004
Estimated Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • 0-3

Life expectancy

  • Not specified


  • WBC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 7.5 g/dL


  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN
  • Bile acid ≤ 2.5 times ULN


  • 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)


  • No severe heart disease


  • 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



  • No prior anticancer chemotherapy

Endocrine therapy

  • Prior anticancer steroids allowed


  • No prior radiotherapy


  • No concurrent pentostatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245141

  Show 51 Study Locations
Sponsors and Collaborators
Japan Rhabdomyosarcoma Study Group
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Study Chair: Hajime Hosoi Kyoto Prefectural University of Medicine
OverallOfficial: Masa-aki Kumagai, MD National Center for Child Health and Development

Layout table for additonal information Identifier: NCT00245141     History of Changes
Other Study ID Numbers: JRSG-UHA-PED03-01
CDR0000453316 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma

Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Protein Synthesis Inhibitors
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors