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

3 1 1

What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Grand Hopital De Charleroi	Charleroi	Belgium
Centre Hospitalier de Mouscron	Mouscron	Belgium
A Z Monica	Antwerp	Belgium
Sint-Lucas General Hospital	Brugge	Belgium
Jessa Ziekenhuis	Hasselt	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Algemeen Ziekenhuis Klina	Brasschaat	Belgium
Chirec	Brussels	Belgium
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Az Maria Middelares Gent	Gent	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Vitaz	Sint-Niklaas	Belgium
Hopital De Libramont	Libramont-Chevigny	Belgium
CHR Verviers	Verviers	Belgium
O.L.Vrouw van Troost	Dendermonde	Belgium
AZ Rivierenland	Rumst	Belgium
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Oxbstk vyl Lrgqmlr Zwvfoziyjk Wiqdgwe	Waregem	Belgium
Stxjuvfpws Zgwojrztfo	Sint-Truiden	Belgium
Rhykriikx zebmetlqkf Hgvlkm Hxji Lznxyv	Leuven	Belgium
Ab Rhpzdqemmoav cctqnn Bevfsg	Bornem	Belgium
Al Ghjsacaj	Ronse	Belgium
Sfibf ec Prauotolyp	Namur	Belgium
Agupcnls Znbmvpxfyb Aesk	Eeklo	Belgium
Cfo Hmcrby	Mons	Belgium
Huq Zjncgxtylqcsvktan Afrakxloo	Antwerp	Belgium
Ujfdfhmtan Of Aiykyus	Edegem	Belgium
Zttecxgtzr Giap	Geel	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.01.2018

Trial locations

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.

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 ID:

2022-502798-40-00

Protocol code:

BE 2017-001397-41

NCT ID:

NCT03464305

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?