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NCT03464305Active, not recruitingPhase 3

ASPIRIN Trial Belgium

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

Source: ClinicalTrials.gov · Last updated 19 Mar 2024

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
148 (actual)
First submitted
7 Mar 2018
Start date
22 Feb 2018
Primary completion date
31 Dec 2027
Lead sponsor
University Hospital, Antwerp
NCT number
NCT03464305

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 148
  • From 22 Feb 2018 to the primary completion date, 31 Dec 2027
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 currently taking high dose systemic glucocorticoids (≥ 30 mg predniso(lo)n or equivalent)

Other illness

  • Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
  • Patients with a history of bleeding disorders or active gastric or duodenal ulcers
  • 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

Who the study is looking for

  • 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

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ziekenhuis Netwerk Antwerpen (ZNA)
Coordinator of this site? Confirm its status
AntwerpBelgiumUnknown status
Gasthuiszusters Ziekenhuizen (GZA)
Coordinator of this site? Confirm its status
AntwerpBelgiumUnknown status
AZ Rivierenland campus Bornem (Sint Jozefkliniek)
Coordinator of this site? Confirm its status
BornemBelgiumUnknown status
Clinique Saint-Luc
Coordinator of this site? Confirm its status
BougeBelgiumUnknown status
AZ KLINA
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BrasschaatBelgiumUnknown status
AZ Sint-Lucas
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BrugesBelgiumUnknown status
CHIREC
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BrusselsBelgiumUnknown status
Grand Hopital de Charleroi
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CharleroiBelgiumUnknown status
AZ Sint-Blasius
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DendermondeBelgiumUnknown status
AZ Monica
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DeurneBelgiumUnknown status
UZ Antwerpen
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EdegemBelgiumUnknown status
AZ Alma
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EekloBelgiumUnknown status
AZ Sint-Dimpna
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GeelBelgiumUnknown status
AZ Maria Middelares
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GhentBelgiumUnknown status
JESSA Ziekenhuis
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HasseltBelgiumUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
RZ Heilig Hart
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LeuvenBelgiumUnknown status
CH de l'Ardenne
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LibramontBelgiumUnknown status
CHR de la Citadelle
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LiègeBelgiumUnknown status
CHU Ambroise Paré
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MonsBelgiumUnknown status
CH de Mouscron
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MouscronBelgiumUnknown status
CHU UCL Namur - Site De Sainte-Elisabeth
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NamurBelgiumUnknown status
Clinique Saint Pierre
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Ottignies-Louvain-la-NeuveBelgiumUnknown status
az Glorieux
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RonseBelgiumUnknown status
AZ Rivierenland campus Rumst (Heilige Familie)
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RumstBelgiumUnknown status
VITAZ (AZ Nikolaas)
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Sint-NiklaasBelgiumUnknown status
AZ Sint-Trudo
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Sint-TruidenBelgiumUnknown status
CHR Verviers
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VerviersBelgiumUnknown status
OLV van Lourdes Ziekenhuis
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WaregemBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.