ASPIRIN Trial Belgium

Phase 3

Active, not recruiting

• Conditions: Colon Cancer
• Interventions: Drug: Placebo; Drug: acetylsalicylic acid

• Registration Number: NCT03464305
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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

Detailed Description

The purpose of this study is to determine 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 of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (\<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Study Timeline

• Study Start: 2018-02-22
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Aspirin	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	5 years	The time to an event for DFS is defined as the time interval between the date of randomisation and the date of disease recurrence or death, whichever comes first. Recurrence of a disease can be a loco-regional recurrence, a distant recurrence or a new primary colon cancer. The evidence for recurrence must be documented in the patients' file.
Time to Treatment Failure	5 years	The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.

Trial Locations

Locations (29)

Ziekenhuis Netwerk Antwerpen (ZNA); 🇧🇪 Antwerpen, Belgium

AZ Klina; 🇧🇪 Brasschaat, Antwerpen, Belgium

AZ Sint-Lucas; 🇧🇪 Brugge, Belgium

AZ Alma; 🇧🇪 Eeklo, Belgium

AZ Sint-Blasius; 🇧🇪 Dendermonde, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, 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

CHR Verviers; 🇧🇪 Verviers, Belgium

RZ Heilig Hart; 🇧🇪 Leuven, Belgium

AZ Glorieux; 🇧🇪 Ronse, Belgium

OLV van Lourdes Ziekenhuis; 🇧🇪 Waregem, Belgium

AZ Rivierenland campus Rumst (Heilige Familie); 🇧🇪 Rumst, Antwerpen, Belgium

Gasthuiszusters Ziekenhuizen (GZA); 🇧🇪 Antwerpen, Belgium

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium

AZ Rivierenland campus Bornem (Sint Jozefkliniek); 🇧🇪 Bornem, Antwerpen, Belgium

AZ Monica; 🇧🇪 Deurne, Antwerpen, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium

CHIREC; 🇧🇪 Brussels, Belgium

AZ Sint-Dimpna; 🇧🇪 Geel, Belgium

CH de l'Ardenne; 🇧🇪 Libramont, Belgium

Clinique Saint-Pierre; 🇧🇪 Ottignies-Louvain-la-Neuve, Belgium

VITAZ (AZ Nikolaas); 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

Clinique Saint-Luc; 🇧🇪 Bouge, Belgium

AZ Sint-Trudo; 🇧🇪 Sint-Truiden, Belgium