Overview

ASPIRIN Trial Belgium

Status:
Recruiting

Trial end date:
2026-12-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Antwerp

Collaborators:

Anticancerfund
Kom Op Tegen Kanker

Treatments:

Aspirin

Criteria

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