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AzTrials

Colon CancerPhase 3ASPIRINNCT03464305

ASPIRIN Trial Belgium

A Phase 3 study testing acetylsalicylic acid in people with Colon Cancer, run by University Hospital, Antwerp at 29 sites in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 45 years and older
Conditions the study is for
Colon Cancer
What is being tested?
acetylsalicylic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
29 sitesBelgium
Study dates
22 Feb 2018to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Belgium29 sites

  • Ziekenhuis Netwerk Antwerpen (ZNA)

    Antwerp, 2020

  • Gasthuiszusters Ziekenhuizen (GZA)

    Antwerp, 2610

  • AZ Rivierenland campus Bornem (Sint Jozefkliniek)

    Bornem, Antwerpen, 2880

  • Clinique Saint-Luc

    Bouge, 5004

  • AZ Klina

    Brasschaat, Antwerpen, 2930

  • AZ Sint-Lucas

    Bruges, 8310

  • CHIREC

    Brussels, 1160

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • AZ Sint-Blasius

    Dendermonde, 9200

  • AZ Monica

    Deurne, Antwerpen, 2100

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • AZ Alma

    Eeklo, 9900

  • AZ Sint-Dimpna

    Geel, 2440

  • AZ Maria Middelares

    Ghent, 9000

  • Jessa Ziekenhuis

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • RZ Heilig Hart

    Leuven, 3000

  • CH de l'Ardenne

    Libramont, 6800

  • CHR de la Citadelle

    Liège, 4000

  • CHU Ambroise Paré

    Mons, 7000

  • CH de Mouscron

    Mouscron, 7700

  • CHU UCL Namur Site de Sainte-Elisabeth

    Namur, 5000

  • Clinique Saint-Pierre

    Ottignies-Louvain-la-Neuve, 1340

  • AZ Glorieux

    Ronse, 9600

  • AZ Rivierenland campus Rumst (Heilige Familie)

    Rumst, Antwerpen, 2840

  • VITAZ (AZ Nikolaas)

    Sint-Niklaas, Oost-Vlaanderen, 9100

  • AZ Sint-Trudo

    Sint-Truiden, 3800

  • CHR Verviers

    Verviers, 4800

  • OLV van Lourdes Ziekenhuis

    Waregem, 8790

Other trials in Belgium

About this study

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

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

Read the 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
Being tested
acetylsalicylic acid, Placebo
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
Medical subject headings
Colonic Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Colonic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acetylsalicylic acidDrug

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

  • PlaceboDrug

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

Study groups in NCT03464305
Study groupRoleWhat they receive
AspirinExperimentalPatients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
Receives: Drug: acetylsalicylic acid
PlaceboPlacebo comparatorPatients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

Secondary outcomes (2)

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2018
  2. Study start22 Feb 2018
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03464305
Sponsor's protocol ID
BE 2017-001397-41
Acronym
ASPIRIN
Status last verified
Mar 2024
First submitted
7 Mar 2018
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing acetylsalicylic acid in people with Colon Cancer, run by University Hospital, Antwerp at 29 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5 year overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03464305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.

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