Table 3.

Study end points.

Primary end point   - Adverse events defined by NCI CTCAE version 5.0 Secondary end points   - Efficacy, measured by RECIST 1.1, Peritoneal Regression Grading Score and Peritoneal Carcinomatosis Index   - Post-operative surgical complications, measured by Clavien-Dindo classification 4 weeks after each PIPAC   - Overall survival, measured by time from initiation of treatment to death   - Progression-free survival, measured by time from initiation of treatment to progression   - Patient-reported health status/quality of life and symptoms before treatment and at 6-week intervals until the patient comes off study, as measured by the EQ-5D-5L and MDASI   - Functional status, as measured by the number of daily steps before and after treatments (wristband pedometer) Exploratory end point   - Nab-paclitaxel concentrations in plasma and tissues

CTCAE: Common Terminology Criteria for Adverse Events; MDASI: MD Anderson Symptom Inventory; NCI: National Cancer Institute; PIPAC: Pressurized intraperitoneal aerosolized chemotherapy; RECIST: Response Evaluation Criteria in Solid Tumors.