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Status:

COMPLETED

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Adult Rhabdomyosarcoma

Embryonal Childhood Rhabdomyosarcoma

Eligibility:

All Genders

Up to 49 years

Phase:

PHASE3

Brief Summary

This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as v...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radioth...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:
  • Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):
  • Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease
  • Stage 1 and clinical group III (gross residual disease) disease arising in the orbit
  • Stage 2 and clinical group I or II disease
  • Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011):
  • Stage 1 and clinical group III disease arising in a non-orbit site
  • Stage 3 and clinical group I or II disease
  • Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)
  • If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III
  • Prior regional lymph node sampling required for patients with extremity tumors
  • None of the following diagnoses:
  • Intermediate-risk embryonal RMS
  • Metastatic embryonal RMS
  • Alveolar RMS
  • Undifferentiated sarcoma
  • RMS not otherwise specified (NOS)
  • Other soft tissue sarcoma, including sarcoma NOS
  • Prior enrollment on clinical trial COG-D9902
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 50-100% (≥ 16 years old)
  • Performance status - Lansky 50-100% (\< 16 years old)
  • Absolute neutrophil count at least 750/mm\^3
  • Platelet count at least 75,000/mm\^3 (transfusion independent)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)\*
  • Creatinine\* based on age/gender as follows:
  • No greater than 0.8 mg/dL for patients age 5 and under
  • No greater than 1.0 mg/dL for patients age 6 to 9
  • No greater than 1.2 mg/dL for patients age 10 to 12
  • No greater than 1.4 mg/dL for female patients age 13 and over
  • No greater than 1.5 mg/dL for male patients age 13 to 15
  • No greater than 1.7 mg/dL for male patients age 16 and over
  • Creatinine clearance\* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m\^2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No prior chemotherapy (except for patients treated on the related intermediate-risk study)
  • Prior steroids allowed
  • No prior radiotherapy

Exclusion

    Key Trial Info

    Start Date :

    September 4 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 30 2021

    Estimated Enrollment :

    390 Patients enrolled

    Trial Details

    Trial ID

    NCT00075582

    Start Date

    September 4 2004

    End Date

    September 30 2021

    Last Update

    November 19 2021

    Active Locations (163)

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    Page 1 of 41 (163 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    3

    University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724

    4

    University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205