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Study on Aspirin for Preventing Recurrence and Improving Survival in Patients with Resected Colon Cancer

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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 colon cancer treatment. The trial involves patients who have had surgery to remove colon cancer. The treatment being tested is acetylsalicylic acid, commonly known as aspirin, which is given in a dose of 80 milligrams once daily. The study will compare the effects of aspirin with a placebo, which looks like the aspirin tablet but does not contain any active medication.

The purpose of the study is to understand how aspirin affects the chances of cancer coming back and the overall survival of patients with stage II and III colon cancer. Participants in the study will take either aspirin or a placebo every day for up to five years. The study is designed to be "double-blind," meaning neither the participants nor the researchers know who is receiving aspirin and who is receiving the placebo, to ensure unbiased results.

Throughout the study, researchers will monitor the participants' health to see if the cancer returns and to track their overall survival. The main goal is to see if taking aspirin can help improve survival rates over five years. The study will also look at how long patients remain free from cancer and how long they can continue the treatment without any issues. This research aims to provide valuable insights into the potential benefits of aspirin for patients who have undergone surgery for colon cancer.

The research process

The trial runs in 4 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, you will be randomly assigned to one of two groups. One group will receive the medication acetylsalicylic acid, commonly known as aspirin, and the other group will receive a placebo, which is a substance with no active medication.

    This process is called a 'double-blind' study, meaning neither you nor the researchers will know which group you are in. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    If you are in the group receiving acetylsalicylic acid, you will take a dose of 80 mg orally once a day.

    This medication will be taken daily for a duration of 5 years.

  3. Step 3

    Regular follow-up

    Throughout the study, regular follow-up appointments will be scheduled to monitor your health and any effects of the treatment.

    These appointments will include assessments to check for any recurrence of colon cancer and to evaluate your overall health status.

  4. Step 4

    End of study

    The study is expected to conclude by December 31, 2027.

    At the end of the study, the data collected will be analyzed to determine the effect of acetylsalicylic acid on the recurrence and survival of colon cancer patients.

Who can join the trial?

5 criteria

  • Patients must be 45 years and older.
  • Patients must have a confirmed diagnosis of adenocarcinoma of the colon. This means a specific type of colon cancer has been identified through a tissue examination.
  • Patients must have a TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2. This refers to the size and extent of the tumor (T), whether cancer has spread to nearby lymph nodes (N), and whether there is any spread to other parts of the body (M). The stages mentioned are part of UICC stage II and III, which are specific classifications of cancer stages.
  • Patients must have had a curative radical resection (R0 resection) within 12 weeks before joining the study. This means the cancerous part of the colon was surgically removed, and no cancer cells were left behind.
  • Patients must provide written informed consent according to national and local regulations. This means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

10 criteria

  • Patients who have not had their colon cancer surgically removed cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are unable to take the study medication, which is 80mg of acetylsalicylic acid (a type of aspirin), cannot participate.
  • Patients who are allergic to aspirin or similar medications cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have a history of bleeding disorders cannot participate.
  • Patients who have a history of stomach ulcers cannot participate.
  • Patients who have severe liver or kidney disease cannot participate.
  • Patients who have a history of heart disease or stroke cannot participate.
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Investigated drugs

Aspirin is a medication that is being studied in this trial to see if it can help improve the chances of survival for people with stage II and III colon cancer. In this study, patients take aspirin once a day for five years. The researchers want to find out if taking aspirin can help prevent the cancer from coming back and help patients live longer. Aspirin is commonly used to relieve pain and reduce inflammation, but in this trial, it is being tested for its potential benefits in cancer treatment.

What is already known about the treatment

Aspirin – Aspirin is taken orally in the form of a pill, usually once a day. It is currently being studied in clinical trials for its potential benefits in improving survival rates in patients with colon cancer. The main therapeutic use being investigated is its ability to help prevent the recurrence of colon cancer after surgery. At the molecular level, aspirin works by inhibiting certain enzymes that promote inflammation and blood clotting, which may also play a role in cancer progression. It is classified as a non-steroidal anti-inflammatory drug (NSAID).

Investigated diseases

Colon Carcinoma – Colon carcinoma is a type of cancer that begins in the large intestine, which is part of the digestive tract. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, the cancer can grow deeper into the walls of the colon and potentially spread to nearby lymph nodes and other organs. The progression of colon carcinoma can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502798-40-00Protocol codeBE 2017-001397-41Estimated enrolment400 patientsSponsorAntwerp University Hospital

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