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Study on Aspirin for Preventing Recurrence and Improving Survival in Patients with Stage II and III 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. Specifically, it examines the use of acetylsalicylic acid, commonly known as aspirin, in patients who have had surgery to remove colon cancer. The trial aims to understand how taking 80 mg of aspirin daily for five years might affect the chances of cancer returning and overall survival in patients with stage II and III colon cancer. Stage II and III refer to the extent of cancer spread, with stage III being more advanced than stage II.

Participants in the study will be randomly assigned to receive either aspirin or a placebo, which is a tablet that looks like aspirin but does not contain any active medication. This is done to compare the effects of aspirin against no active treatment. 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.

The main goal of the study is to see if aspirin can improve the five-year overall survival rate, which is the percentage of people who are still alive five years after treatment. Additionally, the study will look at other outcomes such as disease-free survival, which measures the time patients remain free from cancer, and time to treatment failure, which tracks how long the treatment remains effective. The trial is expected to continue until the end of 2027.

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 is done to ensure unbiased results.

  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 check-ups

    Throughout the study, you will have regular check-ups to monitor your health and any effects of the medication.

    These check-ups are important to ensure your safety and to gather data on the medication's effectiveness.

  4. Step 4

    End of study

    The study is expected to conclude by the end of 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, which is a type of colon cancer.
  • Patients must have a specific stage of colon cancer known as stage II or III. This is determined by a system called TNM, which describes the size and spread of the cancer.
  • Patients must have had a successful surgery to remove the cancer (called R0 resection) within the last 12 weeks before joining the study.
  • Patients must provide written informed consent, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

5 criteria

  • Patients who have not had surgery to remove their colon cancer.
  • Patients who are not in stage II or stage III of colon cancer.
  • Patients who are not able to take acetylsalicylic acid (a type of medication also known as aspirin).
  • Patients who are younger than 18 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Aspirin is a medication commonly used to relieve pain, reduce inflammation, and lower fever. In this clinical trial, it is being studied for its potential to improve survival rates in patients with stage II and III colon cancer. The trial is investigating whether taking aspirin daily for five years can help prevent the recurrence of cancer and increase the overall survival of these patients. Aspirin is taken orally, meaning it is swallowed in pill form.

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 to improve survival rates in patients with resected colon cancer. The main therapeutic use being investigated is its ability to prevent cancer recurrence and improve overall survival in these patients. At the molecular level, aspirin works by inhibiting 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, also known as colon cancer, is a type of cancer that begins in the large intestine (colon), which is the final 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, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colon carcinoma is often categorized into stages, with stage II and III indicating more advanced disease where the cancer has spread beyond the colon to nearby tissues or lymph nodes. Symptoms may include changes in bowel habits, blood in the stool, persistent abdominal discomfort, and unexplained weight loss.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502324-48-00Protocol codeNL38132.058.14Estimated enrolment1 588 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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