Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study|
- Reduction in size of tumors [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Reduction in number of tumors [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Disease free survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 1993|
|Study Completion Date:||January 2006|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
325 mg/day PO
|Placebo Comparator: Placebo||Other: placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002527
Show 42 Study Locations
|Study Chair:||Robert Sandler, MD, MPH||UNC Lineberger Comprehensive Cancer Center|