Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
NCT ID: NCT00006366
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-02-28
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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fluorouracil
irinotecan hydrochloride
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the distal rectum
* Located 0-9 cm from the dentate line (3-12 cm from the anal verge)
* No extension of malignant disease into the anal canal
* Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation
* No evidence of distant metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC (white blood cell count) greater than 4,000/mm\^3
* Platelet count greater than 130,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal
* Alkaline phosphatase, SGOT (serum glutamic oxaloacetic transaminase), and LDH (lactate dehydrogenase) normal
Renal:
* Creatinine normal
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except:
* Inactive nonmelanomatous skin cancer
* Carcinoma in situ of the cervix
* Synchronous colonic cancer if tumor is Tis or T1 and has been completely resected
* No other serious medical illnesses
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to pelvis
Surgery:
* Not specified
Other:
* No concurrent antiepileptic drugs
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Mohammed M. Mohiuddin, MD
Role: STUDY_CHAIR
Lucille P. Markey Cancer Center at University of Kentucky
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
Alabama Oncology, LLC
Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, 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
California Cancer Center
Fresno, California, United States
Sutter Health West Cancer Research Group
Greenbrae, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Huntington Cancer Center
Pasadena, California, United States
Cancer Care Center
Pomona, California, United States
Radiation Oncology Center - Sacramento
Sacramento, California, United States
Radiation Medical Group, Inc.
San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
O'Connor Hospital
San Jose, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
Hospital of St. Raphael
New Haven, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
University of Florida Health Science Center
Gainesville, Florida, United States
Florida Radiation Oncology Group
Jacksonville, Florida, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, United States
Veterans Affairs Medical Center - Miami
Miami, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Bay Medical Center
Panama City, Florida, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Methodist Medical Center of Illinois
Peoria, 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
Clarian Health Partners Inc.
Indianapolis, Indiana, United States
Regional Cancer Center
Indianapolis, Indiana, United States
Ball Memorial Hospital
Muncie, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Louisville Radiation Oncology
Louisville, Kentucky, United States
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 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
Maine Medical Center
Portland, Maine, United States
Anne Arundel Oncology Center
Annapolis, Maryland, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States
Harbor Hospital Center
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
McLaren Regional Cancer Center
Flint, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Marquette General Hospital
Marquette, Michigan, United States
MidMichigan Medical Center - Midland
Midland, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States
Nebraska Health System
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
South Jersey Regional Cancer Center
Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Atlantic City Medical Center
Pomona, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
Associated Radiologists, P.A.
Warren Township, New Jersey, United States
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, 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
Roswell Park Cancer Institute
Buffalo, New York, United States
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
James P. Wilmot Cancer Center
Rochester, 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
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Northeast Medical Center
Concord, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, 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
Trinity Cancer Care Center
Minot, North Dakota, United States
Akron General Medical Center
Akron, Ohio, United States
Akron City Hospital
Akron, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
St. Anthony Hospital
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
St. John Health System
Tulsa, Oklahoma, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Bayshore Medical Center
Pasadena, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Vermont Cancer Center
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
RMH Regional Cancer Center
Harrisonburg, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Bon-Secours - St. Mary's Hospital
Richmond, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Yakima Valley Memorial Hospital
Yakima, Washington, United States
Schiffler Cancer Center
Wheeling, West Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
Columbia Hospital
Milwaukee, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
All Saints Cancer Center
Racine, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Greater Sudbury, Ontario, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Mohiuddin M, Paulus R, Mitchell E, Hanna N, Yuen A, Nichols R, Yalavarthi S, Hayostek C, Willett C. Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):523-8. doi: 10.1016/j.ijrobp.2013.02.020. Epub 2013 Mar 29.
Mohiuddin M, Winter K, Mitchell E, Hanna N, Yuen A, Nichols C, Shane R, Hayostek C, Willett C; Radiation Therapy Oncology Group Trial 0012. Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group Trial 0012. J Clin Oncol. 2006 Feb 1;24(4):650-5. doi: 10.1200/JCO.2005.03.6095.
Mitchell EP, Winter K, Mohiuddin M, et al.: Randomized phase II trial of preoperative combined modality chemoradiation for distal rectal cancer. [Abstract] J Clin Oncol 22 (Suppl 14): A-3535, 253s, 2004.
Mohiuddin M, Winter K, Mitchell E, et al.: Results of RTOG-0012 randomized phase II study of neoadjuvant combined modality chemoradiation for distal rectal cancer. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-16, S138, 2004.
Other Identifiers
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CDR0000068239
Identifier Type: -
Identifier Source: secondary_id
RTOG-R-0012
Identifier Type: -
Identifier Source: org_study_id
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