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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
264
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
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 will be done in accordance with local guidelines
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Rouen University Hospital
Rouen, France
RECRUITINGNumber of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time frame: 3 years
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time frame: 5 years
Number of alive patient
Time frame: 5 years
Number of pills taken by the patient for compliance evaluation
Number of pills taken by the patient will be assess in order to evaluate patient's compliance
Time frame: every 6 months during 3 years
Number of severe bleeding grade 3-4 events
Time frame: 3 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 years
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