Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00006366
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy plus chemotherapy is more effective for rectal cancer.
PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum.
- Detailed Description
OBJECTIVES:
* Compare the pathological complete response, acute and late normal tissue morbidity, patterns of failure, and complete resection rates in patients with locally advanced adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy comprised of hyperfractionated radiotherapy and fluorouracil vs conventional radiotherapy, fluorouracil, and irinotecan, followed by radical resection.
OUTLINE: This is a randomized study. Patients are stratified according to clinical stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive hyperfractionated radiotherapy (RT) twice daily, 5 days a week for 19 days. Patients receive fluorouracil IV continuously over 7 days a week concurrently with RT. Patients with clinical stage T3 or fixed T4 disease also receive a higher boost dose of RT to tumor.
* Arm II: Patients receive conventional RT once daily, 5 days a week for 25 days. Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT. Patients receive irinotecan IV over 1 hour (immediately prior to RT dose) once weekly for 4 weeks. Patients with clinical stage T3 or fixed T4 disease also receive a lower boost dose of RT to tumor.
Within 4-10 weeks after completion of chemoradiotherapy, patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- 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)
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Radiation Medical Group, Inc.
🇺🇸San Diego, California, United States
Cancer Care Center
🇺🇸Pomona, California, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
California Cancer Center
🇺🇸Fresno, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Sutter Health West Cancer Research Group
🇺🇸Greenbrae, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Medical Center/John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Nebraska Health System
🇺🇸Omaha, Nebraska, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Atlantic City Medical Center
🇺🇸Pomona, New Jersey, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Pocono Cancer Center
🇺🇸East Stroudsburg, Pennsylvania, United States
Bayshore Medical Center
🇺🇸Pasadena, Texas, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
McGill University
🇨🇦Montreal, Quebec, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St. Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
Huntington Cancer Center
🇺🇸Pasadena, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Saint Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
Florida Radiation Oncology Group
🇺🇸Jacksonville, Florida, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
Sarasota Radiation and Medical Oncology Center
🇺🇸Sarasota, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
Clarian Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Associated Radiologists, P.A.
🇺🇸Warren, New Jersey, United States
Radiation Oncology Associates of Albuquerque
🇺🇸Albuquerque, New Mexico, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Finger Lakes Radiation Oncology Center
🇺🇸Clifton Springs, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Riverhill Radiation Oncology
🇺🇸Yonkers, New York, United States
Trinity Cancer Care Center
🇺🇸Minot, North Dakota, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
St. John Health System
🇺🇸Tulsa, Oklahoma, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
RMH Regional Cancer Center
🇺🇸Harrisonburg, Virginia, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscaloosa, Alabama, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Regional Radiation Oncology Center at Rome
🇺🇸Rome, Georgia, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
MidMichigan Medical Center - Midland
🇺🇸Midland, Michigan, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, New Jersey, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
All Saints Cancer Center
🇺🇸Racine, Wisconsin, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Hospital of St. Raphael
🇺🇸New Haven, Connecticut, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Bon-Secours - St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada