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Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer Clinical research trials and Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer  Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer
Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer
For Condition: stage 1 rectal cancer,adenocarcinoma of the rectum
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI),Southwest Oncology Group
Synopsis: 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.
Details: 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. PROJECTED ACCRUAL: Approximately 320 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum - T1 or T2 by physical and endoscopic exams - No T3 lesions by clinical or radiological exam - Villous adenomas or in situ carcinoma allowed without histological confirmation if clinical appearance of cancer - No multi-focal disease within the rectum at time of initial diagnosis - No non-adenocarcinomatous rectal cancer or anal cancer - Less than 4 cm at greatest diameter - Less than 40% of rectal wall circumference involved - Proximal margin no greater than 8 cm from dentate line - No tumor fixation to the perirectal tissues regardless of size - No malignant regional lymph node or distant metastases by clinical exam or radiographical imaging - No palpable perirectal lymph nodes or nodes larger than 1 cm - No evidence of malignant perirectal lymph nodes by endorectal ultrasound or endorectal MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - CTC 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times normal Renal: - Creatinine less than 1.8 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins - Prior incision or operative biopsy or colonoscopic removal allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MortonKahlenberg, Study Chair, University of Texas
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-W227
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
United States
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79415
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5500
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Oregon Cancer Institute
Portland, Oregon, 97201-3098
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
United States
Additional Information:
Study ID Numbers: CDR0000068858; CLB-80002,SWOG-C80002
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023751
Other Stage 1 Rectal Cancer Studies:
1. Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
2. Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
3. Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer
4. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
Related Studies:
Other stage 1 rectal cancer Clinical Trials
Other North Carolina Clinical Trials
Other Kinston Clinical Trials
Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer
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