Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
- Registration Number
- NCT00002527
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.
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.
- Detailed Description
OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.
OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 635
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Aspirin aspirin 325 mg/day PO
- Primary Outcome Measures
Name Time Method Reduction in size of tumors Up to 4 years Reduction in number of tumors Up to 4 years Disease free survival Up to 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States