ASPIRIN Trial Belgium

Colon Cancer Clinical Trial

— ASPIRIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03464305
• Other study ID #: BE 2017-001397-41
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 22, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Gasthuiszusters Ziekenhuizen (GZA)	Antwerpen
Belgium	Ziekenhuis Netwerk Antwerpen (ZNA)	Antwerpen
Belgium	AZ Rivierenland campus Bornem (Sint Jozefkliniek)	Bornem	Antwerpen
Belgium	Clinique Saint-Luc	Bouge
Belgium	AZ Klina	Brasschaat	Antwerpen
Belgium	AZ Sint-Lucas	Brugge
Belgium	CHIREC	Brussels
Belgium	Grand Hôpital de Charleroi	Charleroi
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	AZ Monica	Deurne	Antwerpen
Belgium	UZ Antwerpen	Edegem	Antwerpen
Belgium	AZ Alma	Eeklo
Belgium	AZ Sint-Dimpna	Geel
Belgium	AZ Maria Middelares	Gent
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 Rivierenland campus Rumst (Heilige Familie)	Rumst	Antwerpen
Belgium	VITAZ (AZ Nikolaas)	Sint-Niklaas	Oost-Vlaanderen
Belgium	AZ Sint-Trudo	Sint-Truiden
Belgium	CHR Verviers	Verviers
Belgium	OLV van Lourdes Ziekenhuis	Waregem

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Anticancerfund, Kom Op Tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease Free Survival	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.	5 years
Secondary	Time to Treatment Failure	The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.	5 years

External Links

•   Aspirin Trialist Collaborative Group