Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation Stage III or II High Risk
Sponsor: University Hospital, Rouen
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.
Official title: French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2018-07-12
Completion Date
2028-07
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
aspirin intake
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
placebo intake
Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
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
Molecular analysis of exon 9 and 20 of PI3K
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
blood intake
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Locations (1)
Rouen University Hospital
Rouen, France