Application of the method of intraoperative intraperitoneal aerosol chemotherapy (PIPAC) in complex treatment of locally advanced gastric cancer with cytologically negative peritoneal lavages: the protocol for GASPACCO clinical trial

Concept of regional impact on tumor cells, based on the delivery of high doses of a chemotherapeutic drug with an acceptable level of systemic toxicity directly into the peri¬toneum, is thought to be a promising strategy for prevention and treatment of peritoneal carcinomatosis. Intra‐abdominal pressurized ‐ aerosol chemotherapy (PIPAC ‐ Pressurized Intraperitoneal Aerosol Chemotherapy) is a new technology for delivering a chemotherapy drug to the peritoneum for prophylactic purposes in case of advanced gastric cancer, the efficacy and safety of which has not yet been confirmed in randomized clinical trials. Materials and methods. The clinical trial protocol GAS‐ PACCO (Oncological Benefits of PIPAC in Patients With T3‐4 Gastric Cancer Cyt‐), initiated by First Pavlov State Medical University of St. Petersburg has been presented. The clinical trial has been registered on the ClinicalTrials.gov portal under NCT04595929 number. The study design: a single‐center, prospective, randomized clinical trial evaluating the benefits of the intraoperative intra¬peritoneal aerosol chemotherapy (PIPAC) method in the course of the complex treatment of locally advanced T3‐4 gastric cancer and/or with regional lymph nodes affected without dis¬tant metastases and negative cytology from peritoneal lavage • (cyt‐), as compared to standard treatment. Primary cndpoint of the study is overall survival (during the follow‐up). Secondary endpoints of the study are recur¬rence‐free survival, incidence of peritoneal carcinomatosis, incidence of serious adverse events, quality of the patients' life during the postoperative period (EORTC QLQ‐C30), in¬tensity of pain syndrome, postoperative mortality and com¬plications. Materials and methods. Randomization 1:1 for inclu¬sion of 152 patients in each of two arms: the PIPAC group of the active comparison (4 cycles of neoadjuvant chemo¬therapy FLOT ‐ gastrectomy with D2 lymph nodes dis¬section ‐ PIPAC) and the active control group (neoadjuvant chemotherapy ‐ gastrectomy with D2 lymph nodes dissection without PIPAC). Results and discussion. In order to assess the benefits of using the PIPAC method in the course of complex treatment of locally advanced cancer, as compared to standard treatment, 304 patients with locally advanced gastric cancer are planned to be included in the GASPACCO clinical trial.