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

Trial Status Open for recruitment
Phase Phase III
Type of cancer Colon cancer
Study design

A phase III double-blind placebo-controlled randomised trial is proposed. Stage II and III colon cancer patients with or without adjuvant chemotherapy will be randomised between low-dose acetylsalicylic acid (80 mg) or placebo, within 12 weeks after radical resection. Treatment will start at least 10 days after surgery. Study medication will be continued for 5 years. The research question will be addressed in patients with and without adjuvant chemotherapy by means of two parallel studies.


Primary Objective:
• To study 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
Secondary Objective(s):
• To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS)
• To study the effect of acetylsalicylic acid on time to treatment failure (TTF)
• To study the effect of acetylsalicylic acid on toxicity, for example the interaction of acetylsalicylic acid with chemotherapy
Tertiary Objective (s):
• Genetic analysis on surgical specimen from all patients: PIK3CA, BRAF and RAS mutation analysis
•  Evaluation of therapeutic compliance (using a diary on paper and/or via smartphone) and patient reported outcomes (using a web-based customized survey with patient access)
•  Define subpopulations with greater adjuvant benefit using acetylsalicylic acid

Inclusion Main criteria

• Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
• Patients 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 (UICC stage II and III) (in case of >1 tumour: more advanced tumour is stage II or III)
• Patients who have undergone curative radical resection (R0 resection) within 12 weeks prior to study entry
• Written informed consent according to national and local regulation

Exclusion Main criteria

• Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
• Patients currently taking (low-dose) acetylsalicylic acid for any reason
• Patients currently taking oral anti-coagulants or use of LMWH
• 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 (father/mother/brother/sister/son/daughter)
• Allergy or intolerance to salicylates
• Patients with local or distant recurrent disease
• Previous malignancies other than CIN, BCC 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

Treatment schedule

Patients will be randomised to either receive orally acetylsalicylic acid 80 mg once daily or placebo.

Study Period

–Enrolment: 2018- 2021

–End of study 2026 (5 years follow-up)

Study Coordinators

Prof. Dr. Marc Peeters

Participating Groups

Leids Universitair Medisch Centrum (LUMC), the Netherlands

Participating centres

AZ Klina,
AZ Monica
AZ Nikolaas
AZ Heilige Familie
SJK Bornem
AZ Maria Middelares
AZ Glorieux, AZ Sint-Lucas
AZ Sint-Blasius Dendermonde
AZ Sint Dimpna Geel
GZA Antwerpen
OLV van Lourdes zh Waregem
AZ Groeninge
AZ Alma Eeklo
RZ Sint-Trudo
Jessa Ziekenhuis
RZ Heilig Hart Leuven
CHR Verviers
CH de Mouscron
Clinique Saint-Pierre Ottignies
CHU Ambroise Paré
Clinique Saint-Luc Bouge
CH de l'Ardenne
Grand Hôpital de Charleroi

Protocol summary
NCT number NCT03464305
EudraCT 2017-001397-41
Interest to participate
More info