A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University; Leiden University Medical Center
• Collaborators: Anticancer Fund, Belgium; Dutch Colorectal Cancer Group; Fonds NutsOhra; Innovatiefonds Zorgverzekeraars; Stichting Geriatrische Oncologie Nederland (GeriOnNe); Stichting voor Patienten met Kanker aan het Spijsverteringskanaal (SPKS)
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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