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

NCT02945033 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-02-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

aspirin intake

Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years

DRUG

placebo intake

Patient with colonic adenocarcinoma stage III or II high risk will take placebo of 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

Sponsors & Collaborators

  • Federation Francophone de Cancerologie Digestive

    collaborator OTHER

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Pierre MICHEL, Pr · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02945033 on ClinicalTrials.gov