ASPIRIN Trial Belgium (ASPIRIN)

March 16, 2024 updated by: ethisch.comite@uza.be, University Hospital, Antwerp

A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

The purpose of this study is to determine whether acetylsalicylic acid is effective on the recurrence and survival of colon cancer patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Silke Raats, Bach
  • Phone Number: +3238214215
  • Email: aspirin@uza.be

Study Contact Backup

  • Name: Sven De Keersmaecker, Bach
  • Phone Number: +3238214279
  • Email: aspirin@uza.be

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Ziekenhuis Netwerk Antwerpen (ZNA)
      • Antwerpen, Belgium, 2610
        • Gasthuiszusters Ziekenhuizen (GZA)
      • Bouge, Belgium, 5004
        • Clinique Saint-Luc
      • Brugge, Belgium, 8310
        • AZ Sint-Lucas
      • Brussels, Belgium, 1160
        • CHIREC
      • Charleroi, Belgium, 6000
        • Grand Hopital de Charleroi
      • Dendermonde, Belgium, 9200
        • AZ Sint-Blasius
      • Eeklo, Belgium, 9900
        • AZ Alma
      • Geel, Belgium, 2440
        • AZ Sint-Dimpna
      • Gent, Belgium, 9000
        • AZ Maria Middelares
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • RZ Heilig Hart
      • Libramont, Belgium, 6800
        • CH de l'Ardenne
      • Liège, Belgium, 4000
        • CHR de la Citadelle
      • Mons, Belgium, 7000
        • CHU Ambroise Pare
      • Mouscron, Belgium, 7700
        • CH de Mouscron
      • Namur, Belgium, 5000
        • CHU UCL Namur Site de Sainte-Elisabeth
      • Ottignies-Louvain-la-Neuve, Belgium, 1340
        • Clinique Saint-Pierre
      • Ronse, Belgium, 9600
        • AZ Glorieux
      • Sint-Truiden, Belgium, 3800
        • AZ Sint-Trudo
      • Verviers, Belgium, 4800
        • CHR Verviers
      • Waregem, Belgium, 8790
        • OLV van Lourdes Ziekenhuis
    • Antwerpen
      • Bornem, Antwerpen, Belgium, 2880
        • AZ Rivierenland campus Bornem (Sint Jozefkliniek)
      • Brasschaat, Antwerpen, Belgium, 2930
        • AZ Klina
      • Deurne, Antwerpen, Belgium, 2100
        • AZ Monica
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
      • Rumst, Antwerpen, Belgium, 2840
        • AZ Rivierenland campus Rumst (Heilige Familie)
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • VITAZ (AZ Nikolaas)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
  • Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (Union for International Cancer Control (UICC) stage II and III) (in case of >1 tumour: more advanced tumour is stage II or III)
  • Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomization

Exclusion Criteria:

  • Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
  • Patients currently taking oral anti-coagulants or use of LMWH or use of DOACs
  • Patients currently taking (low-dose) acetylsalicylic acid or other anti-aggregantia for any reason
  • Patients with a history of bleeding disorders or active gastric or duodenal ulcers
  • Patients currently taking high dose systemic glucocorticoids (≥ 30 mg predniso(lo)n or equivalent)
  • Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
  • Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
  • Allergy or intolerance to salicylates
  • Patients with local or distant recurrent disease
  • Previous malignancies other than CIN or SCC with a disease free survival less than 5 years
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Drug: acetylsalicylic acid
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Placebo Comparator: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Drug: Placebo
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 year overall survival
Time Frame: 5 years
The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: 5 years
The time to an event for DFS is defined as the time interval between the date of randomisation and the date of disease recurrence or death, whichever comes first. Recurrence of a disease can be a loco-regional recurrence, a distant recurrence or a new primary colon cancer. The evidence for recurrence must be documented in the patients' file.
5 years
Time to Treatment Failure
Time Frame: 5 years
The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Kom Op Tegen Kanker
Anticancerfund

Investigators

  • Principal Investigator: Marc Peeters, Prof dr, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE 2017-001397-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Cancer

Clinical Trials on acetylsalicylic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe