Study Design
This is a phase I nonrandomized and uncontrolled single-arm clinical trial without dose escalation to establish the safety of oxaliplatin PIPAC in cycle 1, and the combination of oxaliplatin PIPAC with 5-FU/LV in cycles 2–3 given within 24 h of the PIPAC. The rules for accrual were based on limiting the risk to that of the traditional 3+3 phase I trial design with modifications that allow for reduced time to complete the study without compromising patient risk.