Status:
ACTIVE_NOT_RECRUITING
A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients
Lead Sponsor:
Leiden University
Collaborating Sponsors:
Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
Dutch Colorectal Cancer Group
Conditions:
Colon Cancer
Adjuvant Therapy
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether acetylsalicylic acidis 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
- Age ≥45 years
- Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of \>1 tumour: largest tumour is stage II or III)
- Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation
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
- Patients currently taking acetylsalicylic acid 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)
- 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 a history of other malignancies in the last 5 years, except for SCC or CIN.
- 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 :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT02301286
Start Date
January 1 2015
End Date
December 1 2027
Last Update
March 18 2024
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
Ziekenhuisgroep Twente
Almelo, Netherlands
2
Meander MC
Amersfoort, Netherlands
3
Wilhelmina Ziekenhuis
Assen, Netherlands
4
Amphia Ziekenhuis
Breda, Netherlands