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Study on the Effectiveness of Aspirin in Patients with Resected Colon Cancer with PI3K Mutation Stage III or II High Risk

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of aspirin on patients who have undergone surgery for colon cancer that has a specific genetic change known as the PI3K mutation. The trial is designed to compare the outcomes of taking aspirin with those of taking a placebo, which is a substance with no active medication. The main goal is to see if aspirin can help prevent the return of cancer within three years after surgery.

Participants in the study will be randomly assigned to receive either aspirin or a placebo. The aspirin used in this study is a 100 mg dose in the form of a gastro-resistant tablet, which means it is designed to dissolve in the intestine rather than the stomach. This helps to reduce stomach irritation. The study will last for a period of up to 36 months, during which participants will take the medication orally.

The trial aims to assess the disease-free survival rate, which refers to the length of time after treatment during which the patient remains free of cancer. Additionally, the study will monitor overall survival rates and any side effects, such as severe bleeding or other adverse events. The results will help determine if aspirin is effective in improving outcomes for patients with this type of colon cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of colon cancer, and genetic mutations.

    Written consent is required to participate in the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either aspirin or a placebo.

    The study is double-blind, meaning neither the participants nor the researchers know who receives aspirin or placebo.

  3. Step 3

    Medication administration

    Participants take one gastro-resistant tablet daily.

    The tablet contains either 100 mg of acetylsalicylic acid (aspirin) or a placebo made of cellulose powder and starch.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor health and any side effects.

    Participants are observed for disease-free survival over a period of 3 years.

  5. Step 5

    End of study

    The study concludes after 3 years of monitoring.

    Data on disease recurrence, new cancer development, or any cause of death is collected to evaluate the effectiveness of aspirin.

Who can join the trial?

9 criteria

  • Must be **18 years or older**.
  • Must have **colon cancer** that is either stage III or stage II with high risk. This means the cancer has certain characteristics that make it more serious.
  • Must have a **PI3K mutation** in the tumor, specifically in exon 9 or 20. This is a specific change in the cancer's genetic material.
  • Must know the **RAS status**. This is another genetic detail about the cancer.
  • Must have had a **successful surgery** to remove the cancer, known as R0 resection, meaning no cancer cells were left behind.
  • Must have a **WHO performance status** of 0 to 2. This is a measure of how well you can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Must have had a **chest and abdominal CT scan** within the last 12 weeks. This is an imaging test to check for any remaining cancer.
  • Must have **signed a written consent** to participate in the study.
  • Women who can have children must agree to use **effective birth control** during the study.

Who cannot join the trial?

5 criteria

  • Patients who have not had surgery to remove colon cancer.
  • Patients whose colon cancer does not have a PI3K mutation. A PI3K mutation is a change in a specific gene that can affect cancer growth.
  • Patients with colon cancer that is not at stage III or stage II high risk. These stages describe how advanced the cancer is.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study does not include.
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Investigated drugs

Aspirin is being tested in this clinical trial to see if it can help improve disease-free survival in patients who have had surgery for colon cancer with a specific genetic mutation called PI3K. The study aims to find out if taking aspirin can prevent the cancer from coming back within three years after surgery.

What is already known about the treatment

Aspirin – Aspirin is typically administered orally in tablet form. It is a well-established medication widely used in medicine, with extensive literature supporting its use. In this clinical trial, aspirin is being investigated for its potential to improve disease-free survival in patients with resected colon cancer with a PI3K mutation, specifically at stage III or high-risk stage II. Aspirin works by inhibiting an enzyme called cyclooxygenase, which plays a role in inflammation and blood clotting. It is classified as a non-steroidal anti-inflammatory drug (NSAID).

Investigated diseases

Colon Cancer with PI3K Mutation – This is a type of colon cancer characterized by a mutation in the PI3K gene, which can influence the growth and spread of cancer cells. It typically occurs in the colon, which is part of the large intestine. The disease is often classified into stages, with stage III indicating more advanced local spread and stage II high risk suggesting a significant potential for progression. After surgical removal of the tumor, the focus is on monitoring for any recurrence of cancer. The progression of this disease can involve local or distant recurrence, or the development of a second colorectal cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516007-16-00Protocol codePRODIGE 50 - ASPIKEstimated enrolment264 patientsSponsorCentre Hospitalier Universitaire Rouen

sourced from the EU Clinical Trials Register and site verification

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