Ricerc@Sapienza

Among peritoneal surface malignancy settings, in patients with peritoneal metastases from gastric cancer integrated therapies have unfortunately to date have achieved modest results. Despite numerous series using combined cytoreductive surgery (CRS) with intraperitoneal hyperthermic chemotherapy (HIPEC) preoperative neoadjuvant therapy has proved indispensable to downstage disease and increase the number of patients scheduled for radical surgery. In choosing the ideal neoadjuvant therapy for these patients approaches differ widely among Asian and Western authors. Whereas Western series invariably use systemic chemotherapy (SC) variously integrated with biologic drugs, Asian researchers, especially Japanese, have for many years undertaken a therapeutic neoadjuvant approach foreseeing intraperitoneal normothermic chemotherapy combined with SC and prepared with oral fluoro according to a scheme known under the acronym neoadjuvant intraperitoneal and systemic chemotherapy (NIPS). These two strategies, also owing to their geographically distant locations, have been hard to compare and even when compared problems concerning patient selection have made the results difficult to interpret. Our randomized control study intends to select two homogeneous groups of patients and thus test the efficacy of the two neoadjuvant approaches. The underlying rationale is that, apart from tolerability and adverse effects, by using a more aggressive approach (NIPS) we can increase the percentage of patients likely to benefit from radical surgery. Our multicenter randomized control trial will enroll 184 patients with PMs from GC (92 in each arm) having homogenous clinical pathological characteristics related to PM extent and spread, who will undergo SC or NIPS.