ASPIRIN Trial Belgium
ASPIRIN
A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
1 other identifier
interventional
148
1 country
29
Brief Summary
The purpose of this study is to determine whether acetylsalicylic acid is effective on the recurrence and survival of colon cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2018
Longer than P75 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2018
CompletedFirst Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 19, 2024
March 1, 2024
9.9 years
March 7, 2018
March 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
5 year overall survival
The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.
5 years
Secondary Outcomes (2)
Disease Free Survival
5 years
Time to Treatment Failure
5 years
Study Arms (2)
Aspirin
EXPERIMENTALPatients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Placebo
PLACEBO COMPARATORPatients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Interventions
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Kom Op Tegen Kankercollaborator
- Anticancerfundcollaborator
Study Sites (29)
AZ Rivierenland campus Bornem (Sint Jozefkliniek)
Bornem, Antwerpen, 2880, Belgium
AZ Klina
Brasschaat, Antwerpen, 2930, Belgium
AZ Monica
Deurne, Antwerpen, 2100, Belgium
UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
AZ Rivierenland campus Rumst (Heilige Familie)
Rumst, Antwerpen, 2840, Belgium
VITAZ (AZ Nikolaas)
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Ziekenhuis Netwerk Antwerpen (ZNA)
Antwerp, 2020, Belgium
Gasthuiszusters Ziekenhuizen (GZA)
Antwerp, 2610, Belgium
Clinique Saint-Luc
Bouge, 5004, Belgium
AZ Sint-Lucas
Bruges, 8310, Belgium
CHIREC
Brussels, 1160, Belgium
Grand Hôpital de Charleroi
Charleroi, 6000, Belgium
AZ Sint-Blasius
Dendermonde, 9200, Belgium
AZ Alma
Eeklo, 9900, Belgium
AZ Sint-Dimpna
Geel, 2440, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
RZ Heilig Hart
Leuven, 3000, Belgium
CH de l'Ardenne
Libramont, 6800, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
CHU Ambroise Paré
Mons, 7000, Belgium
CH de Mouscron
Mouscron, 7700, Belgium
CHU UCL Namur Site de Sainte-Elisabeth
Namur, 5000, Belgium
Clinique Saint-Pierre
Ottignies-Louvain-la-Neuve, 1340, Belgium
AZ Glorieux
Ronse, 9600, Belgium
AZ Sint-Trudo
Sint-Truiden, 3800, Belgium
CHR Verviers
Verviers, 4800, Belgium
OLV van Lourdes Ziekenhuis
Waregem, 8790, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Peeters, Prof dr
University Hospital, Antwerp
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Marc Peeters, Diensthoofd Oncologie
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
February 22, 2018
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 19, 2024
Record last verified: 2024-03