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

June 12, 2026 updated by: University Hospital, Rouen

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with aspirin intake
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. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
Drug: aspirin intake
Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
Procedure: 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
Biological: Molecular analysis of exon 9 and 20 of PI3K
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
Biological: blood intake
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Placebo Comparator: Patient with placebo intake
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. If the mutation is detected, patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years. Blood intake will be done every 6 months to evaluate patient compliance to treatment
Procedure: 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
Biological: Molecular analysis of exon 9 and 20 of PI3K
Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
Biological: blood intake
Blood intake will be done every 6 months to evaluate patient compliance to treatment
Drug: placebo intake
Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patient with local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Time Frame: 5 years
5 years
Number of alive patient
Time Frame: 5 years
5 years
Number of pills taken by the patient for compliance evaluation
Time Frame: every 6 months during 3 years
Number of pills taken by the patient will be assess in order to evaluate patient's compliance
every 6 months during 3 years
Number of severe bleeding grade 3-4 events
Time Frame: 3 years
3 years
Number of participants with treatment-related adverse events
Time Frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Pierre MICHEL, Pr, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2018

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimated)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/222/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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