Clinical trial · Interventional
ASPIRIN Trial Belgium
A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
NCT03464305CI-TRIAL-00075201ASPIRINactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether acetylsalicylic acid is effective on the recurrence and survival of colon cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylsalicylic acid | Drug | Aspirin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aspirin
- description
- Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
- interventionNames
- Drug: acetylsalicylic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- 5 year overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.