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OncoMatch/Clinical Trials/NCT02945033

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

Is NCT02945033 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Molecular analysis of exon 9 and 20 of PI3K and blood intake for colorectal cancer.

Phase 3RecruitingUniversity Hospital, RouenNCT02945033Data as of May 2026

Treatment: aspirin intake · Molecular analysis of exon 9 and 20 of PI3K · blood intakeFour 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: PIK3CA mutation, exon 9 or 20

PI3K mutation, exon 9 or 20 (tumour)

Disease stage

Required: Stage III, II HIGH RISK

Colonic adenocarcinoma stage III; Colonic adenocarcinoma stage II high risk MSS: T4bN0 or T4aN0 tumour penetrating the surface of the visceral peritoneum or less than 12 nodes evaluated; or with at least two of the following criteria: lymphatic involvement, perineural invasion, venous invasion or diagnosis of bowel obstruction or perforation; or poor differentiated tumour.

Performance status

WHO 0–2

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