colon cancer, aspirin, survival, elderly coloncarcinoom, aspirine, survival, ouderen
Conditions
Interventions
Aspirin 80 mg once daily during 5 years or placebo after surgery.
Follow-up of the colon cancer according to national guidelines, no additional visits or interventions besides aspirin or placebo.
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the colon 2. TNM stage: 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) 3. Age ≥ 45 years 4. Completed surgical resection (R0) within 12 weeks of randomisation 5. Written informed consent according to local Ethics Committee requirements
Exclusion criteria
Exclusion criteria: 1. Rectal cancer (defined as tumor within 15 cm from the anal verge) 2. Currently taking oral anti-coagulants. 3. Currently taking (low-dose) aspirin for any reason 4. History of bleeding disorders or active gastric or duodenal ulcers 5. Currently taking high dose (≥ 30 mg predniso(lo)ne) systemic glucocorticoids 6. Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome) 7. Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member 8. Local or distant recurrent disease 9. Allergy or intolerance for salicylates 10. History of other malignancies in the last 5 years, except for SSC, BCC or CIN 11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the effect of acetylsalicylic acid on 3 year disease free survival (DFS) 2. To study the effect of acetylsalicylic acid on time to treatment failure (TTF) 3. To study the effect of acetylsalicylic acid on toxicity, for example the interaction of acetylsalicylic acid with chemotherapy. | — |
Contacts
Public ContactDatacenter Heelkunde
Leids Universitair Medisch Centrum
Outcome results
None listed