Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00002995
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.
PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.
- Detailed Description
OBJECTIVES:
* Determine the failure-free survival (FFS) rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy.
* Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin, vincristine, and cyclophosphamide with or without radiotherapy.
* Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements (embryonal histiotype) who receive one of the above treatments.
* Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens.
OUTLINE: Patients are assigned to 1 of 2 groups, depending on histology and site of disease.
* Group I (favorable tumor site, negative lymph nodes, stage 1, clinical group I, IIA, or III (orbit only), node negative \[N0\] OR unfavorable tumor site, negative or unknown lymph nodes, stage 2, clinical group I): Patients receive vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses. Treatment repeats every 12 weeks for 4 courses. Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8.
* Group II (favorable tumor site, positive lymph nodes, stage 1, clinical group III (orbit only), node positive \[N1\] OR favorable tumor site except orbit, any lymph nodes, stage 1, clinical group III OR unfavorable tumor site, stage 2, clinical group II OR unfavorable tumor site, stage 3, clinical group I or II): Patients receive vincristine and dactinomycin as in group I. Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover. Radiotherapy is administered on weeks 3-8, 12-17, or 28-33, if clinically indicated as in group I.
Patients are followed every 3-4 months for 3 years (4 years after diagnosis), every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 254 patients for group I will be accrued for this study within 6 years. Approximately 12 patients per year will be accrued for group II.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure-free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (232)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
University of South Alabama Cancer Research Institute
🇺🇸Mobile, Alabama, United States
Joe DiMaggio Children's Hospital at Memorial
🇺🇸Hollywood, Florida, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Sacred Heart Children's Hospital
🇺🇸Pensacola, Florida, United States
University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Advocate Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
🇺🇸Atlanta, Georgia, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Riley Children Cancer Center at Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Baystate Regional Cancer Program at Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
St. Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Spectrum Health and DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Comprehensive Cancer Center at Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
William Beaumont Hospital - Royal Oak
🇺🇸Royal Oak, Michigan, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Valerie Fund Children's Center at Atlantic Health
🇺🇸Summit, New Jersey, United States
East Tennessee State University Cancer Center at Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
Children's Hospital of Columbus
🇺🇸Columbus, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Palmetto Health South Carolina Cancer Center
🇺🇸Columbia, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Dakota Cancer Institute at Innovis Health - Dakota Clinic
🇺🇸Fargo, North Dakota, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Forum Health-Tod Childrens Hospital
🇺🇸Youngstown, Ohio, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sioux Valley Hospital at University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Bellin Memorial Hospital
🇺🇸Green Bay, Wisconsin, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Swiss Pediatric Oncology Group Lausanne
🇨ðŸ‡Lausanne, Switzerland
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
San Jorge Childrens Hospital
🇵🇷Santurce, Puerto Rico
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Mary Bridge Children's Hospital and Health Center
🇺🇸Tacoma, Washington, United States
Carilion Medical Center for Children
🇺🇸Roanoke, Virginia, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
🇺🇸San Diego, California, United States
Children's Hospital and Health Center, San Diego
🇺🇸San Diego, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospitals and Clinics - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics
🇺🇸San Antonio, Texas, United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
🇺🇸San Antonio, Texas, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
New York Medical College
🇺🇸Valhalla, New York, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Children's Hospital at Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Doernbecher Children's Hospital at Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Centre de Recherche du Centre Hospitalier de l'Universite Laval
🇨🇦Sainte Foy, Quebec, Canada
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
St. Joseph's Children's Hospital
🇺🇸Tampa, Florida, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Hospital of Omaha
🇺🇸Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Children's Hospitals and Clinics - Minnesota
🇺🇸Saint Paul, Minnesota, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Mission Hospitals
🇺🇸Asheville, North Carolina, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
🇺🇸Greenville, North Carolina, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Center for Cancer Prevention and Care at Scott and White Clinic
🇺🇸Temple, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Swiss Pediatric Oncology Group Geneva
🇨ðŸ‡Geneva, Switzerland
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Brookdale University Hospital and Medical Center
🇺🇸Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
University Hospital at State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
St. Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Swiss Pediatric Oncology Group Bern
🇨ðŸ‡Bern, Switzerland
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Nemours Children's Clinic-Orlando
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Shands Cancer Center at the University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States