Clinical trial NCT03464305: ASPIRIN Trial Belgium
Official title: A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Aspirin
Recurrence
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
name: Anticancerfund
First posted: 2018-03-14
Enrollment: 148
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 5 year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
measure: Time to Treatment Failure
timeFrame: 5 years
Other outcomes:
Locations:
city: Bornem
country: Belgium
facility: AZ Rivierenland campus Bornem (Sint Jozefkliniek)
state: Antwerpen
city: Brasschaat
country: Belgium
facility: AZ Klina
state: Antwerpen
city: Deurne
country: Belgium
facility: AZ Monica
state: Antwerpen
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Rumst
country: Belgium
facility: AZ Rivierenland campus Rumst (Heilige Familie)
state: Antwerpen
city: Sint-Niklaas
country: Belgium
facility: VITAZ (AZ Nikolaas)
state: Oost-Vlaanderen
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen (ZNA)
city: Antwerpen
country: Belgium
facility: Gasthuiszusters Ziekenhuizen (GZA)
city: Bouge
country: Belgium
facility: Clinique Saint-Luc
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Brussels
country: Belgium
facility: CHIREC
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Eeklo
country: Belgium
facility: AZ Alma
city: Geel
country: Belgium
facility: AZ Sint-Dimpna
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: RZ Heilig Hart
city: Libramont
country: Belgium
facility: CH de l'Ardenne
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Mouscron
country: Belgium
facility: CH de Mouscron
city: Namur
country: Belgium
facility: CHU UCL Namur Site de Sainte-Elisabeth
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Clinique Saint-Pierre
city: Ronse
country: Belgium
facility: AZ Glorieux
city: Sint-Truiden
country: Belgium
facility: AZ Sint-Trudo
city: Verviers
country: Belgium
facility: CHR Verviers
city: Waregem
country: Belgium
facility: OLV van Lourdes Ziekenhuis
Study officials:
affiliation: University Hospital, Antwerp
name: Marc Peeters, Prof dr
role: PRINCIPAL_INVESTIGATOR
References: