Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
- Conditions
- Stage III Adult Soft Tissue SarcomaRecurrent Adult Soft Tissue SarcomaStage IVA Adult Soft Tissue SarcomaStage IIB Adult Soft Tissue SarcomaStage IIC Adult Soft Tissue Sarcoma
- Registration Number
- NCT00017160
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use 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. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients who have primary or recurrent sarcoma.
- Detailed Description
OBJECTIVES:
* Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide, radiotherapy, and surgical resection.
* Assess local-regional control in patients treated with this regimen.
* Determine the disease-free survival of patients treated with this regimen.
* Determine the pathologic response in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine the complications in patients treated with this regimen.
OUTLINE: Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4. Patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity. Beginning 2-4 weeks after chemotherapy, patients undergo radiotherapy daily, 5 days a week, for 5-6 weeks. Beginning 4-7 weeks after radiotherapy, patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 24 months.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (235)
USC/Norris Comprehensive Cancer Center and Hospital
πΊπΈLos Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
πΊπΈLos Angeles, California, United States
Valley Hospital
πΊπΈRidgewood, New Jersey, United States
Naval Medical Center, Portsmouth
πΊπΈPortsmouth, Virginia, United States
CCOP - Atlanta Regional
πΊπΈAtlanta, Georgia, United States
Western Pennsylvania Hospital
πΊπΈPittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
πΊπΈPittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
πΊπΈSeattle, Washington, United States
CCOP - Southern Nevada Cancer Research Foundation
πΊπΈLas Vegas, Nevada, United States
Sylvester Cancer Center, University of Miami
πΊπΈMiami, Florida, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
πΊπΈIndianapolis, Indiana, United States
Clarian Health Partners Inc.
πΊπΈIndianapolis, Indiana, United States
Community Regional Cancer Care
πΊπΈIndianapolis, Indiana, United States
Veterans Affairs Medical Center - Miami
πΊπΈMiami, Florida, United States
Baptist Hospital of Miami
πΊπΈMiami, Florida, United States
Radiation Medical Group, Incorporated
πΊπΈSan Diego, California, United States
Christ Hospital
πΊπΈCincinnati, Ohio, United States
Vanderbilt-Ingram Cancer Center
πΊπΈNashville, Tennessee, United States
University of Utah Health Sciences Center
πΊπΈSalt Lake City, Utah, United States
Foundation for Cancer Research and Education
πΊπΈPhoenix, Arizona, United States
MBCCOP - Hawaii
πΊπΈHonolulu, Hawaii, United States
Trinity Cancer Care Center
πΊπΈMinot, North Dakota, United States
Norris Cotton Cancer Center
πΊπΈLebanon, New Hampshire, United States
John F. Kennedy Medical Center
πΊπΈEdison, New Jersey, United States
Newark Beth Israel Medical Center
πΊπΈNewark, New Jersey, United States
Atlantic City Medical Center
πΊπΈPomona, New Jersey, United States
Elliot Regional Cancer Center
πΊπΈManchester, New Hampshire, United States
Schiffler Cancer Center
πΊπΈWheeling, West Virginia, United States
Northwestern Memorial Hospital
πΊπΈChicago, Illinois, United States
Mary Bird Perkins Cancer Center
πΊπΈBaton Rouge, Louisiana, United States
Associated Radiologists, P.A.
πΊπΈWarren, New Jersey, United States
Saint John Regional Hospital
π¨π¦Saint John, New Brunswick, Canada
Jackson-Madison County General Hospital
πΊπΈJackson, Tennessee, United States
Trinitas Hospital - Jersey Street Campus
πΊπΈElizabeth, New Jersey, United States
St. Francis Medical Center
πΊπΈTrenton, New Jersey, United States
MBCCOP - LSU Health Sciences Center
πΊπΈNew Orleans, Louisiana, United States
Maine Medical Center
πΊπΈPortland, Maine, United States
CCOP - Ochsner
πΊπΈNew Orleans, Louisiana, United States
Rapid City Regional Hospital
πΊπΈRapid City, South Dakota, United States
Monmouth Medical Center
πΊπΈLong Branch, New Jersey, United States
University Hospitals of Cleveland
πΊπΈCleveland, Ohio, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
πΊπΈMount Holly, New Jersey, United States
Cancer Institute of New Jersey
πΊπΈNew Brunswick, New Jersey, United States
Community Medical Center
πΊπΈToms River, New Jersey, United States
Fox Chase Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
University of Tennessee Cancer Institute
πΊπΈMemphis, Tennessee, United States
Tom Baker Cancer Center - Calgary
π¨π¦Calgary, Alberta, Canada
CCOP - Greenville
πΊπΈGreenville, South Carolina, United States
Centre Hospitalier Universitaire de Quebec
π¨π¦Quebec City, Quebec, Canada
Saskatoon Cancer Centre
π¨π¦Saskatoon, Saskatchewan, Canada
Allan Blair Cancer Centre
π¨π¦Regina, Saskatchewan, Canada
CHUS-Hopital Fleurimont
π¨π¦Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
π¨π¦Montreal, Quebec, Canada
McGill University
π¨π¦Montreal, Quebec, Canada
Nova Scotia Cancer Centre
π¨π¦Halifax, Nova Scotia, Canada
Newfoundland Cancer Treatment and Research Foundation
π¨π¦St. Johns, Newfoundland and Labrador, Canada
University of Alabama at Birmingham Comprehensive Cancer Center
πΊπΈBirmingham, Alabama, United States
University of Colorado Cancer Center
πΊπΈDenver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
πΊπΈDenver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
πΊπΈDetroit, Michigan, United States
Henry Ford Hospital
πΊπΈDetroit, Michigan, United States
St. Anthony Hospital
πΊπΈOklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
πΊπΈOklahoma City, Oklahoma, United States
CCOP - Columbia River Program
πΊπΈPortland, Oregon, United States
Mayo Clinic Cancer Center
πΊπΈRochester, Minnesota, United States
H. Lee Moffitt Cancer Center and Research Institute
πΊπΈTampa, Florida, United States
Methodist Hospital Cancer Center - Omaha
πΊπΈOmaha, Nebraska, United States
Nebraska Health System
πΊπΈOmaha, Nebraska, United States
Columbia Hospital
πΊπΈMilwaukee, Wisconsin, United States
St. Luke's Medical Center
πΊπΈMilwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
πΊπΈMilwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
πΊπΈMilwaukee, Wisconsin, United States
CCOP - Central Illinois
πΊπΈDecatur, Illinois, United States
Regional Radiation Oncology Center at Rome
πΊπΈRome, Georgia, United States
Memorial Hospital Cancer Center
πΊπΈColorado Springs, Colorado, United States
Tallahassee Memorial Healthcare
πΊπΈTallahassee, Florida, United States
Sarasota Radiation and Medical Oncology Center
πΊπΈSarasota, Florida, United States
Greater Baltimore Medical Center and Cancer Center
πΊπΈBaltimore, Maryland, United States
Dana-Farber Cancer Institute
πΊπΈBoston, Massachusetts, United States
Northwest Community Hospital
πΊπΈArlington Heights, Illinois, United States
Ingalls Memorial Hospital
πΊπΈHarvey, Illinois, United States
Louisville Radiation Oncology
πΊπΈLouisville, Kentucky, United States
Tulane University School of Medicine
πΊπΈNew Orleans, Louisiana, United States
Methodist Medical Center of Illinois
πΊπΈPeoria, Illinois, United States
Central Baptist Hospital
πΊπΈLexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
πΊπΈLexington, Kentucky, United States
Ball Memorial Hospital
πΊπΈMuncie, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
πΊπΈDubuque, Iowa, United States
Peninsula Regional Medical Center
πΊπΈSalisbury, Maryland, United States
Harbor Hospital Center
πΊπΈBaltimore, Maryland, United States
Anne Arundel Oncology Center
πΊπΈAnnapolis, Maryland, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
πΊπΈJamaica Plain, Massachusetts, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
πΊπΈBaltimore, Maryland, United States
James P. Wilmot Cancer Center
πΊπΈRochester, New York, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
πΊπΈBaltimore, Maryland, United States
St. Louis University Health Sciences Center
πΊπΈSaint Louis, Missouri, United States
New York Methodist Hospital
πΊπΈBrooklyn, New York, United States
CCOP - Cancer Research for the Ozarks
πΊπΈSpringfield, Missouri, United States
CCOP - Kansas City
πΊπΈKansas City, Missouri, United States
William Beaumont Hospital - Troy
πΊπΈTroy, Michigan, United States
CCOP - Montana Cancer Consortium
πΊπΈBillings, Montana, United States
Mallinckrodt Institute of Radiology
πΊπΈSaint Louis, Missouri, United States
CCOP - Metro-Minnesota
πΊπΈSaint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
πΊπΈOmaha, Nebraska, United States
Radiation Oncology Associates of Albuquerque
πΊπΈAlbuquerque, New Mexico, United States
South Jersey Regional Cancer Center
πΊπΈMillville, New Jersey, United States
CCOP - Columbus
πΊπΈColumbus, Ohio, United States
Lineberger Comprehensive Cancer Center, UNC
πΊπΈChapel Hill, North Carolina, United States
Barrett Cancer Center
πΊπΈCincinnati, Ohio, United States
State University of New York Health Science Center at Brooklyn
πΊπΈBrooklyn, New York, United States
Finger Lakes Radiation Oncology Center
πΊπΈClifton Springs, New York, United States
Herbert Irving Comprehensive Cancer Center
πΊπΈNew York, New York, United States
Latter Day Saints Hospital
πΊπΈSalt Lake City, Utah, United States
St. John Health System
πΊπΈTulsa, Oklahoma, United States
St. Luke's Hospital Cancer Center
πΊπΈBethlehem, Pennsylvania, United States
Lehigh Valley Hospital
πΊπΈAllentown, Pennsylvania, United States
CCOP - Oklahoma
πΊπΈTulsa, Oklahoma, United States
Geisinger Medical Center
πΊπΈDanville, Pennsylvania, United States
Joe Arrington Cancer Research and Treatment Center
πΊπΈLubbock, Texas, United States
Harrington Cancer Center
πΊπΈAmarillo, Texas, United States
York Cancer Center
πΊπΈYork, Pennsylvania, United States
Roger Williams Medical Center/BUSM
πΊπΈProvidence, Rhode Island, United States
Dixie Regional Medical Center
πΊπΈSaint George, Utah, United States
Cancer Care Ontario-London Regional Cancer Centre
π¨π¦London, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
π¨π¦Toronto, Ontario, Canada
Ottawa Regional Cancer Centre
π¨π¦Ottawa, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
π¨π¦Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
π¨π¦Kingston, Ontario, Canada
Princess Margaret Hospital
π¨π¦Toronto, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
π¨π¦Thunder Bay, Ontario, Canada
Gulf Coast Cancer Treatment Center
πΊπΈPanama City, Florida, United States
Emory University Hospital - Atlanta
πΊπΈAtlanta, Georgia, United States
Medical Center/John B. Amos Community Cancer Center
πΊπΈColumbus, Georgia, United States
McLaren Regional Cancer Center
πΊπΈFlint, Michigan, United States
Merle M. Mahr Cancer Center
πΊπΈMadisonville, Kentucky, United States
Cape Cod Hospital
πΊπΈHyannis, Massachusetts, United States
Marquette General Hospital
πΊπΈMarquette, Michigan, United States
CCOP - Beaumont
πΊπΈRoyal Oak, Michigan, United States
MidMichigan Medical Center - Midland
πΊπΈMidland, Michigan, United States
William Beaumont Hospital
πΊπΈRoyal Oak, Michigan, United States
East Carolina University School of Medicine
πΊπΈGreenville, North Carolina, United States
Ireland Cancer Center
πΊπΈCleveland, Ohio, United States
Akron General Medical Center
πΊπΈAkron, Ohio, United States
Akron City Hospital
πΊπΈAkron, Ohio, United States
Cleveland Clinic Taussig Cancer Center
πΊπΈCleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
πΊπΈColumbus, Ohio, United States
CCOP - Dayton
πΊπΈDayton, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
πΊπΈPhiladelphia, Pennsylvania, United States
Mercy Fitzgerald Hospital
πΊπΈDarby, Pennsylvania, United States
Delaware County Memorial Hospital
πΊπΈDrexel Hill, Pennsylvania, United States
Pocono Cancer Center
πΊπΈEast Stroudsburg, Pennsylvania, United States
Milton S. Hershey Medical Center
πΊπΈHershey, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
πΊπΈPhiladelphia, Pennsylvania, United States
Mercy Hospital of Pittsburgh
πΊπΈPittsburgh, Pennsylvania, United States
Wilkes Barre General Hospital
πΊπΈWilkes-Barre, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
πΊπΈHouston, Texas, United States
Wilford Hall Medical Center
πΊπΈLackland Air Force Base, Texas, United States
Cancer Center at the University of Virginia
πΊπΈCharlottesville, Virginia, United States
RMH Regional Cancer Center
πΊπΈHarrisonburg, Virginia, United States
Deaconess Medical Center
πΊπΈSpokane, Washington, United States
Yakima Valley Memorial Hospital
πΊπΈYakima, Washington, United States
St. Vincent Hospital
πΊπΈGreen Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
πΊπΈMadison, Wisconsin, United States
Marshfield Clinic
πΊπΈMarshfield, Wisconsin, United States
Community Memorial Hospital
πΊπΈMenomonee Falls, Wisconsin, United States
Cancer Center of Albany Medical Center
πΊπΈAlbany, New York, United States
CCOP - North Shore University Hospital
πΊπΈManhasset, New York, United States
Riverhill Radiation Oncology
πΊπΈYonkers, New York, United States
Radiation Oncology Center - Sacramento
πΊπΈSacramento, California, United States
CCOP - Michigan Cancer Research Consortium
πΊπΈAnn Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
πΊπΈAnn Arbor, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
πΊπΈWinston-Salem, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
πΊπΈWinston-Salem, North Carolina, United States
Massey Cancer Center
πΊπΈRichmond, Virginia, United States
Gundersen Lutheran Medical Foundation
πΊπΈLa Crosse, Wisconsin, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
πΊπΈPhiladelphia, Pennsylvania, United States
Albert Einstein Cancer Center
πΊπΈPhiladelphia, Pennsylvania, United States
Hurley Medical Center
πΊπΈFlint, Michigan, United States
Mercy Hospital Cancer Center - Scranton
πΊπΈScranton, Pennsylvania, United States
Reading Hospital and Medical Center
πΊπΈReading, Pennsylvania, United States
Huntsville Hospital System
πΊπΈHuntsville, Alabama, United States
Comprehensive Cancer Institute of Huntsville
πΊπΈHuntsville, Alabama, United States
DCH Cancer Treatment Center
πΊπΈTuscaloosa, Alabama, United States
City of Hope Comprehensive Cancer Center
πΊπΈDuarte, California, United States
Mount Diablo Medical Center
πΊπΈConcord, California, United States
MBCCOP - Gulf Coast
πΊπΈMobile, Alabama, United States
Alabama Oncology, LLC
πΊπΈMontgomery, Alabama, United States
Saint Agnes Cancer Center
πΊπΈFresno, California, United States
California Cancer Center
πΊπΈFresno, California, United States
Sutter Health West Cancer Research Group
πΊπΈGreenbrae, California, United States
Veterans Affairs Medical Center - Long Beach
πΊπΈLong Beach, California, United States
Loma Linda University Medical Center
πΊπΈLoma Linda, California, United States
Huntington Cancer Center
πΊπΈPasadena, California, United States
CCOP - Bay Area Tumor Institute
πΊπΈOakland, California, United States
Robert and Beverly Lewis Family Cancer Care Center
πΊπΈPomona, California, United States
CCOP - Santa Rosa Memorial Hospital
πΊπΈSanta Rosa, California, United States
UCSF Comprehensive Cancer Center
πΊπΈSan Francisco, California, United States
O'Connor Hospital
πΊπΈSan Jose, California, United States
David Grant Medical Center
πΊπΈTravis Air Force Base, California, United States
Hospital of St. Raphael
πΊπΈNew Haven, Connecticut, United States
Saint Mary's Hospital and Medical Center
πΊπΈGrand Junction, Colorado, United States
CCOP - Christiana Care Health Services
πΊπΈNewark, Delaware, United States
University of Florida Health Science Center
πΊπΈGainesville, Florida, United States
Florida Radiation Oncology Group
πΊπΈJacksonville, Florida, United States
CCOP - Mount Sinai Medical Center
πΊπΈMiami Beach, Florida, United States
Holmes Regional Medical Center
πΊπΈMelbourne, Florida, United States
MD Anderson Cancer Center Orlando
πΊπΈOrlando, Florida, United States
Bay Medical Center
πΊπΈPanama City, Florida, United States
Loyola University Medical Center
πΊπΈMaywood, Illinois, United States
Lutheran General Cancer Care Center
πΊπΈPark Ridge, Illinois, United States
St. John's Medical Center
πΊπΈAnderson, Indiana, United States
Bloomington Hospital
πΊπΈBloomington, Indiana, United States
CCOP - Northern Indiana CR Consortium
πΊπΈSouth Bend, Indiana, United States
James Graham Brown Cancer Center
πΊπΈLouisville, Kentucky, United States
CCOP - Kalamazoo
πΊπΈKalamazoo, Michigan, United States
Cancer Research for the Ozarks
πΊπΈSpringfield, Missouri, United States
Ellis Fischel Cancer Center - Columbia
πΊπΈColumbia, Missouri, United States
Veterans Affairs Medical Center - East Orange
πΊπΈEast Orange, New Jersey, United States
Roswell Park Cancer Institute
πΊπΈBuffalo, New York, United States
Vassar Brothers Medical Center
πΊπΈPoughkeepsie, New York, United States
Northeast Medical Center
πΊπΈConcord, North Carolina, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
πΊπΈSyracuse, New York, United States
Champlain Valley Physicians Hospital Medical Center
πΊπΈPlattsburgh, New York, United States
CCOP - Toledo Community Hospital
πΊπΈToledo, Ohio, United States
University of Texas Medical Branch
πΊπΈGalveston, Texas, United States
Bon Secours - St. Mary's Hospital
πΊπΈRichmond, Virginia, United States
Southern Wisconsin Radiotherapy Center
πΊπΈMadison, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
πΊπΈGreen Bay, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
πΊπΈWaukesha, Wisconsin, United States
All Saints Cancer Center
πΊπΈRacine, Wisconsin, United States
Cross Cancer Institute
π¨π¦Edmonton, Alberta, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
π¨π¦Sudbury, Ontario, Canada
CCOP - Upstate Carolina
πΊπΈSpartanburg, South Carolina, United States
Vermont Cancer Center
πΊπΈBurlington, Vermont, United States
Sinai Hospital of Baltimore
πΊπΈBaltimore, Maryland, United States