NCT03464305

ASPIRIN Trial Belgium

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
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.
DRUG	Placebo	Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Timeline

• Start date: 2018-02-22
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2018-03-14
• Last updated: 2024-03-19

Locations

29 sites across 1 country: Belgium