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Spots Global Cancer Trial Database for Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

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Trial Identification

Brief Title: Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

Official Title: Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer

Study ID: NCT00006366

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

CCOP - Mount Sinai Medical Center, Miami Beach, 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

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

Mallinckrodt Institute of Radiology, Saint Louis, Missouri, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri, United States

Cancer Research for the Ozarks, Springfield, Missouri, United States

CCOP - Cancer Research for the Ozarks, Springfield, 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, 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

Dixie Regional Medical Center, Saint George, Utah, United States

University of Utah Health Sciences Center, Salt Lake City, Utah, United States

Latter Day Saints Hospital, Salt Lake City, 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. Johns, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre, Halifax, Nova Scotia, 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

Northeastern Ontario Regional Cancer Centre, Sudbury, Sudbury, 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, Quebec City, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Contact Details

Name: Mohammed M. Mohiuddin, MD

Affiliation: Lucille P. Markey Cancer Center at University of Kentucky

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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