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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023751 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers |
| Study Start Date: | July 2001 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: Approximately 320 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the rectum
No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| Northeast Alabama Regional Medical Center | |
| Anniston, Alabama, United States, 36207 | |
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| CCOP - Greater Phoenix | |
| Phoenix, Arizona, United States, 85006-2726 | |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| Veterans Affairs Medical Center - Tucson | |
| Tucson, Arizona, United States, 85723 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Veterans Affairs Medical Center - Little Rock (McClellan) | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Medical Center - San Diego | |
| San Diego, California, United States, 92161 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| Veterans Affairs Medical Center - West Los Angeles | |
| Los Angeles, California, United States, 90073 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| Veterans Affairs Medical Center - Washington, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| Broward General Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | |
| West Palm Beach, Florida, United States, 33401 | |
| Memorial Regional Hospital Comprehensive Cancer Center | |
| Hollywood, Florida, United States, 33021 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813-2424 | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Tripler Army Medical Center | |
| Honolulu, Hawaii, United States, 96859-5000 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| Saint Anthony Medical Center | |
| Rockford, Illinois, United States, 61108 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153-5500 | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-W227 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
| Hines, Illinois, United States, 60141 | |
| West Suburban Center for Cancer Care | |
| River Forest, Illinois, United States, 60305 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Iowa | |
| Hematology Oncology Associates of the Quad Cities | |
| Bettendorf, Iowa, United States, 52722 | |
| Holden Comprehensive Cancer Center | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7353 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Kentucky | |
| Albert B. Chandler Medical Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0084 | |
| Baptist Hospital East - Louisville | |
| Louisville, Kentucky, United States, 40207 | |
| Veterans Affairs Medical Center - Lexington | |
| Lexington, Kentucky, United States, 40502-2236 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Veterans Affairs Medical Center - Shreveport | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maryland | |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Veterans Affairs Medical Center - Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Memorial Medical Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0912 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Lakeland Medical Center - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| Providence Hospital - Southfield | |
| Southfield, Michigan, United States, 48075-9975 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Veterans Affairs Medical Center - Ann Arbor | |
| Ann Arbor, Michigan, United States, 48105 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201-1932 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Veterans Affairs Medical Center - Biloxi | |
| Biloxi, Mississippi, United States, 39531-2410 | |
| Veterans Affairs Medical Center - Jackson | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Missouri Baptist Cancer Center | |
| Saint Louis, Missouri, United States, 63131 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| Veterans Affairs Medical Center - Las Vegas | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| Veterans Affairs Medical Center - Albuquerque | |
| Albuquerque, New Mexico, United States, 87108-5138 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| Elmhurst Hospital Center | |
| Elmhurst, New York, United States, 11373 | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Albany | |
| Albany, New York, United States, 12208 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Cape Fear Valley Health System | |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| Lenoir Memorial Hospital Cancer Center | |
| Kinston, North Carolina, United States, 28503-1678 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| FirstHealth Moore Regional Hospital | |
| Pinehurst, North Carolina, United States, 28374 | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28402-9025 | |
| NorthEast Oncology Associates | |
| Concord, North Carolina, United States, 28025 | |
| Veterans Affairs Medical Center - Asheville | |
| Asheville, North Carolina, United States, 28805 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| United States, North Dakota | |
| Veterans Affairs Medical Center - Fargo | |
| Fargo, North Dakota, United States, 58102 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195-9001 | |
| Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Veterans Affairs Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45220-2288 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Veterans Affairs Medical Center - Oklahoma City | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Oregon Cancer Institute | |
| Portland, Oregon, United States, 97201-3098 | |
| Veterans Affairs Medical Center - Portland | |
| Portland, Oregon, United States, 97207 | |
| United States, Pennsylvania | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Rhode Island | |
| Lifespan: The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| Veterans Affairs Medical Center - Charleston | |
| Charleston, South Carolina, United States, 29401-5799 | |
| United States, Tennessee | |
| Danville Radiation Therapy Center | |
| Memphis, Tennessee, United States, 38104 | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38103 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| Veterans Affairs Medical Center - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4095 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0565 | |
| Texas Tech University Health Science Center | |
| Lubbock, Texas, United States, 79415 | |
| Veterans Affairs Medical Center - Dallas | |
| Dallas, Texas, United States, 75216 | |
| Veterans Affairs Medical Center - Houston | |
| Houston, Texas, United States, 77030 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78229 | |
| Veterans Affairs Medical Center - Temple | |
| Temple, Texas, United States, 76504 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Veterans Affairs Medical Center - Salt Lake City | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | |
| Burlington, Vermont, United States, 05401 | |
| Green Mountain Oncology Group | |
| Bennington, Vermont, United States, 05201 | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Veterans Affairs Medical Center - White River Junction | |
| White River Junction, Vermont, United States, 05009 | |
| United States, Virginia | |
| Martha Jefferson Hospital | |
| Charlottesville, Virginia, United States, 22901 | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | |
| Roanoke, Virginia, United States, 24014 | |
| Virginia Oncology Associates - Norfolk | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-5000 | |
| Veterans Affairs Medical Center - Seattle | |
| Seattle, Washington, United States, 98108 | |
| United States, West Virginia | |
| St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25701 | |
| United States, Wisconsin | |
| Ministry Medical Group - Northern Region | |
| Rhinelander, Wisconsin, United States, 54501 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Puerto Rico | |
| University of Puerto Rico School of Medicine Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Ronald Bleday, MD | Dana-Farber/Brigham and Women's Cancer Center |
| Study Chair: | Morton S. Kahlenberg, MD | University of Texas |
More Information
| Study ID Numbers: | CDR0000068858, CLB-80002, SWOG-C80002 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00023751 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I rectal cancer adenocarcinoma of the rectum |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Digestive System Neoplasms Vitamin B Complex Growth Substances Adjuvants, Immunologic Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
