NCT00002527

Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	aspirin
OTHER	placebo

Timeline

• Start date: 1993-05-01
• Primary completion: 2003-03-01
• Completion: 2006-01-01
• First posted: 2004-08-31
• Last updated: 2016-07-04

Locations

42 sites across 2 countries: United States, Canada