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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Meander Medical Center Amersfoort The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Slingeland Ziekenhuis Doetinchem The Netherlands
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Haga Hospital Hague The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Wilhelmina Ziekenhuis Assen Assen The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Amphia Hospital Breda The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Elkerliek Ziekenhuis Helmond The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Ziekenhuis St Jansdal Harderwijk The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Elisabeth-Tweesteden Ziekenhuis Tilburg The Netherlands
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Sggqvha Gxfzbhiw Haarlem The Netherlands
Mh Zrhlppsrc Lelystad The Netherlands
Mdyibz Mf Eindhoven The Netherlands
Scnghkbppulqtnkq Ksjwfzid Bhkzjsd Winterswijk The Netherlands
Lscaxcyql Zzhwmvdiad Zoetermeer The Netherlands
Ighjrupxty Zppvnavysr Capelle Aan Den Ijssel The Netherlands
Akhtrvqy Dl Rvvkmj Zqiagdrjtx Bocu Goes The Netherlands
Axsjjlis zaeljnbcia Snlhr Sneek The Netherlands
Bbuxple Ziubwytbyd Gorinchem The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.09.2014

Trial locations

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.

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 ID:
2022-502324-48-00
Protocol code:
NL38132.058.14
NCT ID:
NCT02301286
Trial Phase:
Therapeutic confirmatory (Phase III)

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