Aspirin versus placebo after surgery for PI3K‑mutated stage III or high‑risk stage II colon cancer

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

This trial tests whether taking low‑dose aspirin after surgery helps prevent cancer from coming back in adults whose colon cancer has a PI3K mutation and is stage III or high‑risk stage II.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Rouen)
• Trial ID: NCT02945033 on ClinicalTrials.gov

What this trial studies

This is a randomized Phase 3 trial enrolling adults with R0‑resected colon adenocarcinoma that is stage III or stage II with high‑risk features and a tumor PI3K mutation in exon 9 or 20. Tumor samples are analyzed for PI3K mutation status and eligible patients are randomized to receive low‑dose aspirin or placebo after surgery, with scheduled follow‑up including imaging and blood tests. The trial compares rates of cancer recurrence and survival between the aspirin and placebo groups to generate prospective evidence. It was launched because prior retrospective studies produced mixed results and cannot definitively answer whether aspirin provides adjuvant benefit in this molecularly defined subgroup.

Who should consider this trial

Good fit: Adults aged 18 or older with R0‑resected colon adenocarcinoma stage III or high‑risk stage II, confirmed PI3K exon 9 or 20 tumor mutation, WHO performance status 0–2, and life expectancy of at least three years are the intended participants.

Not a fit: Patients without a PI3K mutation, those with rectal cancer, hereditary colorectal cancer syndromes, current anticoagulant/antiplatelet therapy or contraindications to aspirin are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, low‑dose aspirin could lower the risk of cancer recurrence after surgery for patients with PI3K‑mutated colon cancer.

How similar studies have performed: Retrospective analyses have been mixed, with two studies suggesting a major protective effect of low‑dose aspirin in PI3K‑mutant tumors and two studies showing no benefit, so prospective randomized evidence is still needed.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* 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.
* PI3K mutation, exon 9 or 20 (tumour)
* Resection R0
* WHO performance status 0-2
* Chest and abdominal CT scan ≤ 8 weeks
* Life expectancy ≥ 3 years
* Written consent signed

Exclusion Criteria:

* Anticoagulant and/or Antiaggregating treatment including clopidogrel
* Regular aspirin use (\> 3 doses per week during more than 3 months the last year)
* Contraindication to Aspirin : Allergy to aspirin, Active or antecedent peptic ulcer
* Severe renal or hepatic insufficiency
* Pregnancy or nursing ongoing
* Rectal cancer
* Hereditary forms (i.e. lynch syndrome patients)
* Follow-up of the patient not feasible

Where this trial is running

Rouen

• Rouen University Hospital — Rouen, France (Recruiting)

Study contacts

• Principal investigator: Pierre MICHEL, Pr — University Hospital, Rouen
• Study coordinator: Pierre MICHEL, Pr

Conditions Colorectal Cancer; Pi3k mutation; Aspirin