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Active Not RecruitingNCT02301286

A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

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
770 (actual)
Sponsor
Leiden University · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether acetylsalicylic acidis 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

Interventions

TypeNameDescription
DRUGAcetylsalicylic acid
DRUGPlacebo Acetylsalicylic acid

Timeline

Start date
2015-01-01
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2014-11-25
Last updated
2024-03-18

Locations

32 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02301286. Inclusion in this directory is not an endorsement.