The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer
Official Title: A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers
Study ID: NCT00023751
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 surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer. PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.
Detailed Description: OBJECTIVES: * Determine the overall, disease-free, and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy. * Determine the local, regional, and distant recurrence rates in patients treated with these regimens. * Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens. * Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens. * Determine the anorectal, urinary, and sexual function effects in patients treated with these regimens. * Determine the non-functional treatment morbidity and mortality exclusive of anorectal, urinary, and sexual function effects in patients treated with these regimens. * Determine the overall survival of patients with pathology exclusions undergoing local excision. * Determine the efficacy of the current standard in detecting recurrence during follow-up, including office visits, blood tests, and proctoscopy in patients treated with these regimens. OUTLINE: This is a multicenter study. All patients undergo full thickness disc excision. Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northeast Alabama Regional Medical Center, Anniston, Alabama, United States
MBCCOP - Gulf Coast, Mobile, Alabama, United States
CCOP - Greater Phoenix, Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Veterans Affairs Medical Center - San Diego, San Diego, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
David Grant Medical Center, Travis Air Force Base, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, United States
Broward General Medical Center, Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center, West Palm Beach, Florida, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Saint Anthony Medical Center, Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Baptist Hospital East - Louisville, Louisville, Kentucky, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, 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
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan, United States
Providence Hospital - Southfield, Southfield, Michigan, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Cooper University Hospital, Camden, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Elmhurst Hospital Center, Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital, Jamaica, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
James P. Wilmot Cancer Center, Rochester, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
NorthEast Oncology Associates, Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cape Fear Valley Health System, Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States
New Hanover Regional Medical Center, Wilmington, 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
Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Barrett Cancer Center, Cincinnati, 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
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, United States
Oregon Cancer Institute, Portland, Oregon, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital, Providence, Rhode Island, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
Danville Radiation Therapy Center, Memphis, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, United States
Veterans Affairs Medical Center - Dallas, Dallas, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Veterans Affairs Medical Center - Houston, Houston, Texas, United States
Texas Tech University Health Science Center, Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
Green Mountain Oncology Group, Bennington, Vermont, United States
Vermont Cancer Center, Burlington, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
St. Mary's Medical Center, Huntington, West Virginia, United States
Ministry Medical Group - Northern Region, Rhinelander, Wisconsin, United States
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico
Name: Ronald Bleday, MD
Affiliation: Dana-Farber/Brigham and Women's Cancer Center
Role: STUDY_CHAIR