NCT02945033

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

French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	aspirin intake	Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
DRUG	placebo intake	Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
PROCEDURE	Surgical resection of colonic adenocarcinoma stage III or II high risk	Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines
BIOLOGICAL	Molecular analysis of exon 9 and 20 of PI3K	Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
BIOLOGICAL	blood intake	Blood intake will be done every 6 months to evaluate patient compliance to treatment

Timeline

• Start date: 2018-07-12
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2016-10-26
• Last updated: 2026-02-18

Locations

1 site across 1 country: France