Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

UNKNOWN

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

Lead Sponsor:

Japan Rhabdomyosarcoma Study Group

Conditions:

Sarcoma

Eligibility:

All Genders

Up to 17 years

Phase:

PHASE2

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 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 cyclophosp...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT00245141

    Start Date

    May 1 2004

    Last Update

    August 12 2013

    Active Locations (51)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 13 (51 locations)

    1

    Anjo Kosei Hosptial

    Anjo, Aichi-ken, Japan, 446-8602

    2

    Aichi Medical University

    Nagakuti, Aichi-ken, Japan, 480-1103

    3

    National Hospital Orgnization Nagoya Medical Center

    Nagoya, Aichi-ken, Japan, 460-0001

    4

    Ehime Prefectural Central Hospital

    Matsuyama, Ehime, Japan, 790-0024