Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk

Four retrospective studies were recently published on efficacy of aspirin in patients with surgically resected colon cancer. Two of these studies strongly suggested that aspirin used in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. The other two studies did not confirm the benefit of aspirin in this situation. These four retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as recommended in the conclusion of these studies and meta-analyses to perform a randomised prospective study to validate these data.

NCT Number	NCT02945033
Lead Sponsor	University Hospital, Rouen Collaborators: Federation Francophone de Cancerologie Digestive
Conditions	Colorectal Cancer
Enrollment	264 participants
Start Date	2018-07-12
Primary Completion	2028-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-15