RecruitingPhase 3NCT02945033

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

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

Sponsor

University Hospital, Rouen

Enrollment

264 participants

Start Date

Jul 12, 2018

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking aspirin after surgery for colon cancer (bowel cancer) with a specific genetic mutation (called PI3K mutation) can reduce the chance of the cancer coming back, compared to a placebo (sugar pill). **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with stage III colon cancer, or high-risk stage II colon cancer (cancer that has not spread to distant organs but has grown significantly in the colon wall) - Your tumor has a PI3K mutation (a specific DNA change in the cancer) - You have had surgery that removed all visible cancer (R0 resection) - You are in good enough health to take aspirin regularly **You may NOT be eligible if...** - You have a history of stomach ulcers or internal bleeding - You are already regularly taking aspirin or blood thinners - You have kidney or liver problems that prevent safe aspirin use - You are pregnant or breastfeeding Aspirin has shown cancer-fighting properties in lab studies and this trial tests whether it can prevent colon cancer recurrence. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGaspirin intake

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

DRUGplacebo intake

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

PROCEDURESurgical 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

BIOLOGICALMolecular analysis of exon 9 and 20 of PI3K

Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece

BIOLOGICALblood intake

Blood intake will be done every 6 months to evaluate patient compliance to treatment

Locations(1)

Rouen University Hospital

Rouen, France

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NCT02945033

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