Resected colon cancer with PI3K mutation stage III or II high risk
Conditions
Brief summary
Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first
Detailed description
Disease-free survival at 5 years, Overall survival at 5 years, Compliance to aspirin (comptability of containers), Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0, Adverse event reported and graded according to NCI-CTC grading 4.0, Serious Adverse events will also be described, Subgroups analyses regarding mutations (KRAS and BRAF) for DFS and OS
Interventions
DRUGPlacebo for Aspirin Protect (Cellulose powder
DRUGstarch)
Sponsors
Centre Hospitalier Universitaire Rouen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival at 3 years defined as the time from date of randomisation to date of first local or distant recurrence or second colorectal cancer or death from any cause, whichever occurred first | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival at 5 years, Overall survival at 5 years, Compliance to aspirin (comptability of containers), Severe bleeding grade 3-4 events and hospitalization according to NCI-CTC grading 4.0, Adverse event reported and graded according to NCI-CTC grading 4.0, Serious Adverse events will also be described, Subgroups analyses regarding mutations (KRAS and BRAF) for DFS and OS | — |
Countries
France
Outcome results
None listed