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ASPIRIN Trial Belgium (ASPIRIN)

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
acetylsalicylic acid
Placebo
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring 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

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Rivierenland campus Bornem (Sint Jozefkliniek)Recruiting
  • AZ KlinaRecruiting
  • AZ Monica
  • UZ AntwerpenRecruiting
  • AZ Rivierenland campus Rumst (Heilige Familie)
  • AZ NikolaasRecruiting
  • Ziekenhuis Netwerk Antwerpen
  • Gasthuiszusters ZiekenhuizenRecruiting
  • Clinique Saint-LucRecruiting
  • AZ Sint-LucasRecruiting
  • CHIRECRecruiting
  • Grand Hôpital de CharleroiRecruiting
  • AZ Sint-BlasiusRecruiting
  • AZ Alma
  • AZ Sint-Dimpna
  • AZ Maria MiddelaresRecruiting
  • Jessa Ziekenhuis
  • AZ GroeningeRecruiting
  • RZ Heilig Hart
  • CH de l'ArdenneRecruiting
  • CHR de la CitadelleRecruiting
  • CHU Ambroise Paré
  • CH de Mouscron
  • CHU UCL Namur Site de Sainte-Elisabeth
  • Clinique Saint-PierreRecruiting
  • AZ Glorieux
  • AZ Sint-Trudo
  • CHR VerviersRecruiting
  • OLV van Lourdes ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aspirin

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 7, 2018
Last Updated
December 17, 2020
Sponsor
University Hospital, Antwerp
Collaborators
Kom Op Tegen Kanker, Anticancerfund
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1. Study Identification

Unique Protocol Identification Number
NCT03464305
Brief Title
ASPIRIN Trial Belgium
Acronym
ASPIRIN
Official Title
A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Kom Op Tegen Kanker, Anticancerfund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Primary Outcome Measure Information:
Title
5 year overall survival
Description
The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
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 Frame
5 years
Title
Time to Treatment Failure
Description
The time elapsed between randomisation until treatment discontinuation due to disease progression, unacceptable toxicity, death or any other event of interest.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Raats, Bach
Phone
+3238214215
Email
aspirin@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Sven De Keersmaecker, Bach
Phone
+3238214279
Email
aspirin@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Peeters, MD PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Rivierenland campus Bornem (Sint Jozefkliniek)
City
Bornem
State/Province
Antwerpen
ZIP/Postal Code
2880
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Rondou, Dr
Email
tim.rondou@azr.be
First Name & Middle Initial & Last Name & Degree
Lisbeth Vandenabeele, Dr
Email
lisbeth.vandenabeele@azr.be
First Name & Middle Initial & Last Name & Degree
Tim Rondou, Dr
First Name & Middle Initial & Last Name & Degree
Lisbeth Vandenabeele, Dr
Facility Name
AZ Klina
City
Brasschaat
State/Province
Antwerpen
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Demey, Dr
Phone
+3236505053
First Name & Middle Initial & Last Name & Degree
Charis Loos
Phone
+3236505399
First Name & Middle Initial & Last Name & Degree
Wim Demey, Dr
Facility Name
AZ Monica
City
Deurne
State/Province
Antwerpen
ZIP/Postal Code
2100
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjon De Roose
Phone
+3238214082
Email
marjon.deroose@uza.be
First Name & Middle Initial & Last Name & Degree
Marc Peeters, Prof dr
Facility Name
AZ Rivierenland campus Rumst (Heilige Familie)
City
Rumst
State/Province
Antwerpen
ZIP/Postal Code
2840
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Nikolaas
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Gorleer, Dr
Email
koen.gorleer@aznikolaas.be
First Name & Middle Initial & Last Name & Degree
Roos Haeck
Email
roos.haeck@aznikolaas.be
First Name & Middle Initial & Last Name & Degree
Koen Gorleer, Dr
Facility Name
Ziekenhuis Netwerk Antwerpen
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Gasthuiszusters Ziekenhuizen
City
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Maurissen, Dr
Email
isabelle.maurissen@gza.be
First Name & Middle Initial & Last Name & Degree
Isabelle Maurissen, Dr
Facility Name
Clinique Saint-Luc
City
Bouge
ZIP/Postal Code
5004
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Delescaille
Email
pauline.delescaille@slbo.be
First Name & Middle Initial & Last Name & Degree
Lionel Leclere
Email
lionel.leclere@slbo.be
First Name & Middle Initial & Last Name & Degree
Marylène Clausse, Dr
Facility Name
AZ Sint-Lucas
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Maerten
Email
tania.maerten@stlucas.be
First Name & Middle Initial & Last Name & Degree
Annelies Holvoet, Dr
Facility Name
CHIREC
City
Brussels
ZIP/Postal Code
1160
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugène Mucyo
Email
eugene.mucyo@chirec.be
First Name & Middle Initial & Last Name & Degree
Sandrine Roland, Dr
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janique Dewelle
Email
janique.dewelle@ghdc.be
First Name & Middle Initial & Last Name & Degree
Véronique Pêtre
Email
veronique.petre@ghdc.be
First Name & Middle Initial & Last Name & Degree
Isabelle Sinapi, Dr
Facility Name
AZ Sint-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An Pieters, Dr
Email
an.pieters@azsintblasius.be
First Name & Middle Initial & Last Name & Degree
An Pieters, Dr
First Name & Middle Initial & Last Name & Degree
Marijke Paelinck, Dr
Facility Name
AZ Alma
City
Eeklo
ZIP/Postal Code
9900
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Sint-Dimpna
City
Geel
ZIP/Postal Code
2440
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrien De Bosschere
Email
katrien.debosschere@azmmsj.be
First Name & Middle Initial & Last Name & Degree
Els Monsaert, Dr
First Name & Middle Initial & Last Name & Degree
Erik Vanderstraeten, Dr
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fien Verplancke
Email
fien.verplancke@azgroeninge.be
First Name & Middle Initial & Last Name & Degree
Philippe Vergauwe, Dr
Facility Name
RZ Heilig Hart
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
CH de l'Ardenne
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Baudesson
Email
isabelle.baudesson@vivalia.be
First Name & Middle Initial & Last Name & Degree
Frédéric Forget, Dr
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Lallemant
Email
elisabeth.lallemant@chrcitadelle.be
First Name & Middle Initial & Last Name & Degree
André Frère, Dr
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
CH de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
CHU UCL Namur Site de Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Clinique Saint-Pierre
City
Ottignies-Louvain-la-Neuve
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Vanbellinghen
Email
isabelle.vanbellinghen@cspo.be
First Name & Middle Initial & Last Name & Degree
Jean-Charles Coche, Dr
Facility Name
AZ Glorieux
City
Ronse
ZIP/Postal Code
9600
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Sint-Trudo
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
CHR Verviers
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Rouchet
Email
nathalie.rouchet@chrverviers.be
First Name & Middle Initial & Last Name & Degree
Valérie Graindorge
Email
valerie.graindorge@chrverviers.be
First Name & Middle Initial & Last Name & Degree
Hassan Kalantari, Dr
Facility Name
OLV van Lourdes Ziekenhuis
City
Waregem
ZIP/Postal Code
8790
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronique Buyse, Dr
Email
veronique.buyse@ziekenhuiswaregem.be
First Name & Middle Initial & Last Name & Degree
Veronique Buyse, Dr

12. IPD Sharing Statement

Links:
URL
https://www.lumc.nl/org/atcg/participating-trials/ASPIRINBE/
Description
Aspirin Trialist Collaborative Group

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