Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
NCT ID: NCT00002527
Last Updated: 2016-07-04
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
PHASE3
635 participants
INTERVENTIONAL
1993-05-31
2006-01-31
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.
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Detailed Description
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OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Aspirin
325 mg/day PO
aspirin
Placebo
placebo
Interventions
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aspirin
placebo
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 30 to under 75 Performance status: Physician's assessment of good general health required Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class III/IV status No history of angina No history of MI No history of stroke or TIAs No peripheral vascular disease No bleeding diathesis including hemorrhagic stroke No prophylactic aspirin for cardiovascular disease Other: No documented peptic ulcer disease within past 15 years No aspirin sensitivity including: Aspirin-induced asthma Bronchial hyper-reactivity Urticaria Angioedema No requirement for sodium warfarin or other anticoagulant No frequent (greater than 36 times/year) NSAID use within the past 5 years No recurrent arthritis or other musculoskeletal problems No narcotic or alcohol dependency (unless there has been at least a 6-month period of abstinence) No prior or concurrent malignancy within 5 years (including metastases) except nonmelanomatous skin cancer No pregnant or nursing women Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: No concurrent enrollment in a colon cancer treatment trial or other chemoprevention trial Biologic therapy: At least 6 months since immunosuppressive therapy (i.e., azathioprine, methotrexate, cyclosporine) Chemotherapy: Prior chemotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent chemotherapy Endocrine therapy: Prior non-immunosuppressive steroid treatment allowed Radiotherapy: Prior radiotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent radiotherapy Surgery: Curative resection required
30 Years
74 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Robert Sandler, MD, MPH
Role: STUDY_CHAIR
UNC Lineberger Comprehensive Cancer Center
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic
Saint Cloud, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Altru Health Systems
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Vermont Cancer Center
Burlington, Vermont, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada
Countries
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References
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Sandler RS, Halabi S, Baron JA, Budinger S, Paskett E, Keresztes R, Petrelli N, Pipas JM, Karp DD, Loprinzi CL, Steinbach G, Schilsky R. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. N Engl J Med. 2003 Mar 6;348(10):883-90. doi: 10.1056/NEJMoa021633.
Other Identifiers
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CLB-9270
Identifier Type: -
Identifier Source: secondary_id
E-C9270
Identifier Type: -
Identifier Source: secondary_id
NCCTG-949251
Identifier Type: -
Identifier Source: secondary_id
NCI-P93-0048
Identifier Type: -
Identifier Source: secondary_id
CDR0000078380
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9270
Identifier Type: -
Identifier Source: org_study_id
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