ASPIRIN Trial Belgium

NCT ID: NCT03464305

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2027-12-31

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aspirin

Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.

Group Type: EXPERIMENTAL

acetylsalicylic acid

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

Anticancerfund

UNKNOWN

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

ethisch.comite@uza.be

Prof. dr. Marc Peeters, Diensthoofd Oncologie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Peeters, Prof dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

AZ Rivierenland campus Bornem (Sint Jozefkliniek)

Bornem, Antwerpen, Belgium

AZ Klina

Brasschaat, Antwerpen, Belgium

AZ Monica

Deurne, Antwerpen, Belgium

UZ Antwerpen

Edegem, Antwerpen, Belgium

AZ Rivierenland campus Rumst (Heilige Familie)

Rumst, Antwerpen, Belgium

VITAZ (AZ Nikolaas)

Sint-Niklaas, Oost-Vlaanderen, Belgium

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

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.lumc.nl/org/atcg/participating-trials/ASPIRINBE/

Aspirin Trialist Collaborative Group

Other Identifiers

BE 2017-001397-41

Identifier Type: -

Identifier Source: org_study_id