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Could a daily aspirin keep colon cancer from returning?

NCT ID NCT02945033

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether taking a low-dose aspirin (100 mg) daily for three years can prevent colon cancer from coming back after surgery. It includes 264 people with stage II or III colon cancer who have a specific mutation in the PI3K gene. Participants are randomly assigned to receive either aspirin or a placebo, and researchers track cancer recurrence, new cancers, and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aspirin
What this could lead to
If it works, this could provide a simple, low-cost way to reduce the risk of colon cancer coming back in people with a specific gene mutation.
What could go wrong
This is a phase 3 trial, but earlier studies gave mixed results. Aspirin can cause stomach bleeding or ulcers, and it may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 264 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2018

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Rouen University Hospital

    Rouen, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.