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
- Diseases
- Colorectal cancer
- 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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Netwerk Antwerpen (ZNA) Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Gasthuiszusters Ziekenhuizen (GZA) Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| AZ Rivierenland campus Bornem (Sint Jozefkliniek) Coordinator of this site? Confirm its status | Bornem | Belgium | Unknown status |
| Clinique Saint-Luc Coordinator of this site? Confirm its status | Bouge | Belgium | Unknown status |
| AZ KLINA Coordinator of this site? Confirm its status | Brasschaat | Belgium | Unknown status |
| AZ Sint-Lucas Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| CHIREC Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| AZ Sint-Blasius Coordinator of this site? Confirm its status | Dendermonde | Belgium | Unknown status |
| AZ Monica Coordinator of this site? Confirm its status | Deurne | Belgium | Unknown status |
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| AZ Alma Coordinator of this site? Confirm its status | Eeklo | Belgium | Unknown status |
| AZ Sint-Dimpna Coordinator of this site? Confirm its status | Geel | Belgium | Unknown status |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| RZ Heilig Hart Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CH de l'Ardenne Coordinator of this site? Confirm its status | Libramont | Belgium | Unknown status |
| CHR de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| CHU Ambroise Paré Coordinator of this site? Confirm its status | Mons | Belgium | Unknown status |
| CH de Mouscron Coordinator of this site? Confirm its status | Mouscron | Belgium | Unknown status |
| CHU UCL Namur - Site De Sainte-Elisabeth Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| Clinique Saint Pierre Coordinator of this site? Confirm its status | Ottignies-Louvain-la-Neuve | Belgium | Unknown status |
| az Glorieux Coordinator of this site? Confirm its status | Ronse | Belgium | Unknown status |
| AZ Rivierenland campus Rumst (Heilige Familie) Coordinator of this site? Confirm its status | Rumst | Belgium | Unknown status |
| VITAZ (AZ Nikolaas) Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Unknown status |
| AZ Sint-Trudo Coordinator of this site? Confirm its status | Sint-Truiden | Belgium | Unknown status |
| CHR Verviers Coordinator of this site? Confirm its status | Verviers | Belgium | Unknown status |
| OLV van Lourdes Ziekenhuis Coordinator of this site? Confirm its status | Waregem | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.