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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00354835
First received: July 19, 2006
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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 diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, 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 combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.


Condition Intervention Phase
Adult Malignant Mesenchymoma
Adult Rhabdomyosarcoma
Alveolar Childhood Rhabdomyosarcoma
Childhood Malignant Mesenchymoma
Embryonal Childhood Rhabdomyosarcoma
Embryonal-botryoid Childhood Rhabdomyosarcoma
Nonmetastatic Childhood Soft Tissue Sarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Drug: irinotecan hydrochloride
Biological: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Radiation: radiation therapy
Other: laboratory biomarker analysis
Other: questionnaire administration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Failure-free survival (FFS) [ Time Frame: Time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, or death from any cause, assessed up to 7 years ] [ Designated as safety issue: No ]
    A 1-sided alpha level was chosen as primary interest is in detecting an improvement in FFS under the more intensive therapy. The FFS distributions will be estimated using the Kaplan-Meier method and will be compared between the therapy groups using a log-rank test.

  • Response rate (RR) (complete or partial response) [ Time Frame: At 13 weeks ] [ Designated as safety issue: No ]
    RR between the treatment groups will be compared using a Chi-square test and an upper 95% confidence interval for the difference (VAC/VI-VAC) in proportions will be estimated using a Normal approximation to the binomial distribution. Patients failing or lost to follow-up before 13 weeks will be coded as non-responders for the comparison of response rates. Hypothesis testing will be performed using a one-sided 0.05 alpha level

  • Overall survival (OAS) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The OAS distributions will be estimated using the Kaplan-Meier method and will be compared between the therapy groups using a log-rank test. The repeated confidence interval method proposed by Bernardo and Ibrahim for cure rate models will be used to monitor for early indications of benefit as well as early indications that the study should be stopped in favor of the null hypothesis of no difference in FFS between VAC alternating with VI and VAC.


Secondary Outcome Measures:
  • Long-term FFS of patients with intermediate-risk RMS treated with VAC and early (Week 4) radiotherapy compared to delayed (Week 10) radiotherapy, using IRSIV for historic comparison [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    An analysis plan based on the method of Woolson will be used to monitor for differences in the FFS distribution under the proposed VAC arm relative to the IRS-IV experience for these patients. Outcome data will be formally reviewed, using the Lan-DeMets alpha-spending function implementation of sequential boundaries, after approximately 25%, 50%, 75% and 100% of the expected information has been observed. An alpha spending function of alpha*t will be used, as it is of interest to detect early indications of increased harm relative to historical experience.

  • Local control of patients with intermediate-risk RMS treated with VAC and early (Week 4) radiotherapy compared to delayed (Week 10) radiotherapy, using IRSIV for historic comparison [ Time Frame: From week 4 to week 6 ] [ Designated as safety issue: No ]
    An analysis plan based on the method of Woolson will be used to monitor for differences in the FFS distribution under the proposed VAC arm relative to the IRS-IV experience for these patients.

  • Overall survival of patients with intermediate-risk RMS treated with VAC and early (Week 4) radiotherapy compared to delayed (Week 10) radiotherapy, using IRSIV for historic comparison [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    A similar method of analysis used for the FFS distribution will be used to compare the observed overall survival experience to the historical experience. Cumulative incidence estimators will be used to describe the local failure rate over time.

  • Incidence of toxicity associated with concurrent VI and radiotherapy [ Time Frame: At 12 weeks ] [ Designated as safety issue: Yes ]
    The severe toxicity proportion will be estimated for each therapy group during the first 4 courses of chemotherapy and confidence intervals for the difference in proportions will be estimated. Formal interim monitoring for increased risk will be performed after each quarter of the patients who completed the end of the first 4 cycles of chemotherapy (week 12 following concurrent chemotherapy and radiotherapy) using the Lan-DeMets alpha-spending function implementation of sequential boundaries.

  • Acute and late effects of VAC as delivered on this study to D9803 VAC [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]
    The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.

  • Change in FDG PET maximum standard uptake value (SUVmax) [ Time Frame: Baseline to week 15 ] [ Designated as safety issue: No ]
    The FFS distribution will be compared between groups of subjects defined by a change of at least 40% in SUV between weeks 1 and 4 and between weeks 1 and 15 using a long-rank test. A Cox proportional hazards regression model will be used to compare the FFS distributions between groups of subjects defined by the change in SUV (< 40% versus >= 40%) while adjusting for potential confounding factors, including therapy.

  • Incidence of toxicity related to VI treatment in patients with UGT1A1 genotype [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    Proportion of patients experiencing Grade 3-4 diarrhea and the proportion of patients experiencing Grade 3-4 neutropenia between Weeks 4-9 for patients receiving Regimen B (VAC/VI) will be calculated. A Chi-square test will be used.

  • Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: Yes ]
    The association between mutation status and the occurrence of toxicities during VAC therapy will be investigated using a Chi-square test. The duration of neutropenia and thrombocytopenia will be compared between groups using a 2-sample t-test. Regression modeling will be used to adjust for confounding patient characteristics between genotype groups.

  • Incidence of toxicity related to VAC treatment in patients with CYP2C9 genotypes [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: Yes ]
    The association between mutation status and the occurrence of toxicities during VAC therapy will be investigated using a Chi-square test. The duration of neutropenia and thrombocytopenia will be compared between groups using a 2-sample t-test. Regression modeling will be used to adjust for confounding patient characteristics between genotype groups.

  • Incidence of toxicity related to VAC treatment in patients with GSTA1 genotypes [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: Yes ]
    The association between mutation status and the occurrence of toxicities during VAC therapy will be investigated using a Chi-square test. The duration of neutropenia and thrombocytopenia will be compared between groups using a 2-sample t-test. Regression modeling will be used to adjust for confounding patient characteristics between genotype groups.

  • Gene expression analysis [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The FFS distribution will be compared between groups of subjects defined by the presence of particular genetic classifiers using a log-rank test. A Cox proportional hazards regression model will be used to compare the FFS distributions between groups of subjects defined by the presence of particular genetic classifiers while adjusting for potential confounding factors and established prognostic factors.

  • Bladder function by disease-free patient/parent self report using a 14 point questionnaire [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    If the observed rate of bladder dysfunction at a time-point is 15%, then a 95% confidence interval for the true rate would be about +/- 10%. "Year 6" questionnaires will also be requested from patients completing "year 3" questionnaires, provided they remain disease-free to year 6. The cross-sectional data will provide estimates of the rates of bladder dysfunction, whereas the year 6 follow-up questionnaires will allow an assessment of both the late development of bladder dysfunction and whether there is a return of improved bladder function over time.


Enrollment: 481
Study Start Date: December 2006
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (chemotherapy, radiotherapy)
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiation therapy 5 days a week for 4-6 weeks beginning in week 4.
Biological: dactinomycin
Given IV
Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (chemotherapy, radiotherapy)
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiation therapy 5 days a week for 4-6 weeks beginning in week 4.
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Biological: dactinomycin
Given IV
Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354835

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90242
City of Hope Medical Center
Duarte, California, United States, 91010
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Miller Children's Hospital
Long Beach, California, United States, 90806
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Mattel Children's Hospital UCLA
Los Angeles, California, United States, 90095
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Children's Hospital Central California
Madera, California, United States, 93636-8762
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Childrens Hospital of Orange County
Orange, California, United States, 92868-3874
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Sutter General Hospital
Sacramento, California, United States, 95816
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States, 94143
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Lee Memorial Health System
Fort Myers, Florida, United States, 33901
University of Florida
Gainesville, Florida, United States, 32610
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Miami Children's Hospital
Miami, Florida, United States, 33155
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Florida Hospital
Orlando, Florida, United States, 32803
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, United States, 33607
Saint Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60614
University of Chicago
Chicago, Illinois, United States, 60637
University of Illinois
Chicago, Illinois, United States, 60612
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Hospital.
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61602
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States, 46260
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Children's Hospital-Main Campus
New Orleans, Louisiana, United States, 70118
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Michigan State University Clinical Center
East Lansing, Michigan, United States, 48824-7016
Hurley Medical Center
Flint, Michigan, United States, 48502
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States, 49008
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Winthrop University Hospital
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
New York University Langone Medical Center
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Mercy Children's Hospital
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Greenville Cancer Treatment Center
Greenville, South Carolina, United States, 29605
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Tech University Health Science Center-Amarillo
Amarillo, Texas, United States, 79106
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Childrens Hospital
Herston, Queensland, Australia, 4029
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6008
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada, L8S 4L8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Children's Hospital
London, Ontario, Canada, N6A 5W9
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Puerto Rico
San Jorge Children's Hospital
San Juan, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group - Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group - Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Douglas Hawkins, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00354835     History of Changes
Other Study ID Numbers: ARST0531, NCI-2009-00427, COG-ARST0531, CDR0000487560, ARST0531, ARST0531, U10CA180886, U10CA098543
Study First Received: July 19, 2006
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesenchymoma
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Sarcoma
Liver Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Dactinomycin
Irinotecan
Cyclophosphamide
Vincristine
Camptothecin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2014