Status:
ACTIVE_NOT_RECRUITING
ASPIRIN Trial Belgium
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Kom Op Tegen Kanker
Anticancerfund
Conditions:
Colon Cancer
Eligibility:
All Genders
45+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03464305
Start Date
February 22 2018
End Date
December 31 2027
Last Update
March 19 2024
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Rivierenland campus Bornem (Sint Jozefkliniek)
Bornem, Antwerpen, Belgium, 2880
2
AZ Klina
Brasschaat, Antwerpen, Belgium, 2930
3
AZ Monica
Deurne, Antwerpen, Belgium, 2100
4
UZ Antwerpen
Edegem, Antwerpen, Belgium, 2650