Trial management plan

A detailed planning and trial setup and submission package for ethical approval will be prepared for the accrual of 3 times 5 healthy subjects as well as 150 patients with metastasised colon cancer in Pisa 50 Amsterdam 50 and Cambridge 50 taking into account gender balance Based on our CAIRO2 CAPOXB treatment arm data and given a uniform accrual of 150 colorectal cancer patients over a time course of 1 year with a minimum followup of two treatment cycles ie 29 weeks and with a maximum of 6 FOLFOX cycles we expect 65 cases to end in progression within the timespan of the project