PIPAC EstoK 01: Pressurized IntraPeritoneal Aerosol Chemotherapy with cisplatin and doxorubicin (PIPAC C/D) in gastric peritoneal metastasis: a randomized and multicenter phase II study.

backgroundPeritoneal metastasis (PM) from gastric cancer often remains undiagnosed until it reaches an advanced stage. Despite curative management combining perioperative systemic chemotherapy, cytoreductive surgery (CRS), and hyperthermic intraperitoneal chemotherapy (HIPEC), treated patients' 5 year survival rate remains under 20 % when patients are carefully selected. Palliative intravenous chemotherapy in patients with non-resectable cancer is frequently associated with poor long-term benefit and an estimated survival time below 1 year. Recently, two retrospectives studies reported that Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) improves patients' overall survival without impairing their quality of life (QoL). This promising result needs however to be studied on large randomized clinical trial to validate the effect of PIPAC on survival and QoL of patients with gastric PM.

methodsPIPAC EstoK 01 is a prospective, open, randomized multicenter phase II clinical study with two arms that aims at evaluating the effects of PIPAC with doxorubicin and cisplatin on patients with PM of gastric cancer with peritoneal cancer index (PCI)>8, treated with systemic chemotherapy between two PIPAC procedures. Patients were randomized at the end of explorative laparoscopy and after signing a written consent. Patients received in the first experimental arm a treatment associating PIPAC and systemic chemotherapy (1 PIPAC then 2 IV Chemo) and systemic chemotherapy only in the control arm. Primary endpoint was progression-free survival from the date of surgery to the date of death, or to the end of the 5 year follow-up. Secondary endpoint was 2 year overall survival, morbidity, QoL and secondary resectability rate. The number of patients randomized was calculated to be 94.

trial registrationRetrospectively registered.