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Status:

COMPLETED

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Adult Rhabdomyosarcoma

Childhood Alveolar Rhabdomyosarcoma

Eligibility:

All Genders

Up to 49 years

Phase:

PHASE3

Brief Summary

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly dia...

Detailed Description

PRIMARY OBJECTIVES: I. To compare the early response rates, failure-free survival (FFS), and survival of patients with intermediate-risk rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study
  • Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology review is required for all patients
  • Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of central pathology review results
  • Patient must have Intermediate-risk RMS defined as:
  • Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and group III OR
  • Alveolar RMS: stage 1-3 and group I-III
  • Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for all patients \>= 10 years of age with paratesticular tumors and for patients \< 10 years with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement, defined as two or more lymph nodes \> 2 cm in dimension, is identified by imaging studies)
  • Regional lymph node sampling or sentinel lymph node procedure is required for histologic evaluation in patients with extremity tumors
  • Clinically or radiographically enlarged nodes should be sampled for histologic evaluation
  • Detection of metastasis by optional FDG PET (not required for study enrollment); FDG PET may detect abnormalities suggestive of metastasis not identified by bone scan, computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic significance of FDG PET-detected abnormalities is not clear; FDG PET-detected abnormalities MUST be confirmed to be metastases by an additional imaging modality (such as magnetic resonance imaging \[MRI\] or CT) OR pathologic confirmation; unless FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET abnormalities will NOT be considered evidence of metastasis
  • Patients must have a performance status of 0, 1, or 2; the Lansky performance score should be used for patients \< 16 years and the Karnofsky performance score for patients \>= 16 years
  • Patients who have received prior chemotherapy (excluding steroids) or radiation therapy, except for patients transferring from ARST0331 (low-risk study), are not eligible
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
  • 1 month to \< 6 months: 0.4 mg/dL
  • 6 months to \< 1 year: 0.5 mg/dL
  • 1 to \< 2 years: 0.6 mg/dL
  • 2 to \< 6 years: 0.8 mgt/dL
  • 6 to \< 10 years: 1 mg/dL
  • 10 to \< 13 years: 1.2 mg/dL
  • 13 to \< 16 years: 1.5 mg/dL (males) or 1.4 mg/dL (females)
  • \>= 16 years: 1.7 mg/dL (males) or 1.4 mg/dL (females)
  • Patients with urinary tract obstruction by tumor must meet the renal function criteria AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
  • Total bilirubin =\< 1.5 x upper limit of normal for age
  • Peripheral absolute neutrophil count (ANC) \>= 750/uL
  • Platelet count \>= 75,000/uL (transfusion independent)
  • No evidence of uncontrolled infection
  • Patients must be able to undergo radiation therapy, if necessary, as specified in the protocol
  • Female patients of childbearing potential must have a negative pregnancy test
  • Female patients who are breast feeding must agree to stop breast feeding
  • Sexually active patients of childbearing potential must be willing to use effective contraception during therapy and for at least 1 month after treatment is completed
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion

    Key Trial Info

    Start Date :

    December 26 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2022

    Estimated Enrollment :

    481 Patients enrolled

    Trial Details

    Trial ID

    NCT00354835

    Start Date

    December 26 2006

    End Date

    December 31 2022

    Last Update

    January 31 2023

    Active Locations (226)

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    Page 1 of 57 (226 locations)

    1

    Children's Hospital of Alabama

    Birmingham, Alabama, United States, 35233

    2

    University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States, 35233

    3

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    4

    Banner University Medical Center - Tucson

    Tucson, Arizona, United States, 85719