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 - 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
Scroll for more (32 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States