Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
NCT ID: NCT00075582
Last Updated: 2021-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2004-09-04
2021-09-30
Brief Summary
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Detailed Description
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I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy.
SECONDARY OBJECTIVES:
I. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor.
III. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group.
REGIMEN I (subset 1 patients) \[closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy\*\*, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose.
REGIMEN II (subset 2 patients)\[closed to accrual as of 9/23/2011\]: Patients receive VAC chemotherapy and radiotherapy\*\* as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, and continued VA\* chemotherapy. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: \*For both regimens, dactinomycin is omitted during radiotherapy.
NOTE: \*\*Clinical Group I tumors and those with Clinical Group III uterine/cervix primary disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at Week 13 do not receive radiotherapy at Week 13
Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen I (chemotherapy, radiotherapy)
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)
dactinomycin
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
radiation therapy
Undergo radiotherapy
Regimen II (chemotherapy, radiotherapy, surgery)
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).
conventional surgery
Some patients may undergo second-look surgery
dactinomycin
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
radiation therapy
Undergo radiotherapy
Interventions
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conventional surgery
Some patients may undergo second-look surgery
dactinomycin
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
radiation therapy
Undergo radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
49 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David Walterhouse, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Children's Oncology Group
Arcadia, California, United States
Southern California Permanente Medical Group
Downey, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital and Research Center at Oakland
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Childrens Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
M D Anderson Cancer Center- Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, United States
Saint Mary's Hospital
West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
University of Illinois
Chicago, Illinois, United States
Childrens Memorial Hospital
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Raymond Blank Children's Hospital
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Children's Hospital-Main Campus
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Michigan State University - Breslin Cancer Center
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
The Childrens Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Hospitals Inc
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
West Virginia University Charleston
Charleston, West Virginia, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Sydney West Area Health Service-Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Hospital Sainte-Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Starship Children's Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
San Jorge Children's Hospital
Santurce, , Puerto Rico
Swiss Pediatric Oncology Group - Geneva
Geneva, , Switzerland
Swiss Pediatric Oncology Group - Lausanne
Lausanne, , Switzerland
Countries
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References
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Woolson RF (1981) Rank-tests and a one-sample log-rank test for comparing observed survival-data to a standard population. Biometrics 37: 687-696.
Proia AD. Spindle Cell/Sclerosing Rhabdomyosarcoma of the Orbit. Ophthalmic Plast Reconstr Surg. 2023 Jan-Feb 01;39(1):e17-e20. doi: 10.1097/IOP.0000000000002252. Epub 2022 Jul 13.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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NCI-2009-00425
Identifier Type: REGISTRY
Identifier Source: secondary_id
COG-ARST0331
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000347078
Identifier Type: OTHER
Identifier Source: secondary_id
ARST0331
Identifier Type: -
Identifier Source: org_study_id