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Active, not recruiting Phase 3

ASPIRIN Trial Belgium

NCT03464305 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 3
Started
2018-02-22
Last updated
2024-03-19

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

acetylsalicylic acid →Placebo

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: Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

Study summary

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

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 5 year overall survival — 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.

Trial sites (29)

FacilityCityRegionStatus
AZ Rivierenland campus Bornem (Sint Jozefkliniek) Bornem Antwerpen
AZ Klina Brasschaat Antwerpen
AZ Monica Deurne Antwerpen
UZ Antwerpen Edegem Antwerpen
AZ Rivierenland campus Rumst (Heilige Familie) Rumst Antwerpen
VITAZ (AZ Nikolaas) Sint-Niklaas Oost-Vlaanderen
Ziekenhuis Netwerk Antwerpen (ZNA) Antwerp Belgium
Gasthuiszusters Ziekenhuizen (GZA) Antwerp Belgium
Clinique Saint-Luc Bouge Belgium
AZ Sint-Lucas Bruges Belgium
CHIREC Brussels Belgium
Grand Hôpital de Charleroi Charleroi Belgium
AZ Sint-Blasius Dendermonde Belgium
AZ Alma Eeklo Belgium
AZ Sint-Dimpna Geel Belgium
AZ Maria Middelares Ghent Belgium
Jessa Ziekenhuis Hasselt Belgium
AZ Groeninge Kortrijk Belgium
RZ Heilig Hart Leuven Belgium
CH de l'Ardenne Libramont Belgium
CHR de la Citadelle Liège Belgium
CHU Ambroise Paré Mons Belgium
CH de Mouscron Mouscron Belgium
CHU UCL Namur Site de Sainte-Elisabeth Namur Belgium
Clinique Saint-Pierre Ottignies-Louvain-la-Neuve Belgium
AZ Glorieux Ronse Belgium
AZ Sint-Trudo Sint-Truiden Belgium
CHR Verviers Verviers Belgium
OLV van Lourdes Ziekenhuis Waregem Belgium
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03464305 on ClinicalTrials.gov ↗ ← All trials in Belgium