Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.

Inclusion Criteria:Restricted to 18 to 80 years of ageEastern Cooperative Oncology Group (ECOG) performance status =< 2Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomasAbsolute neutrophil count >= 1,500 / uLPlatelets >= 50,000 / UlSerum creatinine <= 1.5 mg / dLAdequate nutritional status (Albumin >= 3.5)Metastasis confined to the peritoneum:Positive peritoneal cytologyPeritoneal metastasis on diagnostic laparoscopyPeritoneal metastasis on imagingResponse to systemic chemotherapy defined as at least one of the following:Reduction ( >= 30%) in standardized uptake value (SUV) max (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging ( >= 20% decrease in the longest diameter of target lesion) RECIST criteriaReduction ( >= 30%) in Peritoneal Carcinomatosis Index [PCI] or conversion of peritoneal cytologyReduction ( >= 30%) in serum tumor markers CEA or CA 19-9Peritoneal Carcinomatosis Index (PCI) =< 7 and surgeon deems high likelihood for a complete cytoreductionBody Mass Index (BMI) =< 35 kg/m^2Must enroll in Institutional Review Board (IRB) 14-009873 (NCT02530983)Exclusion Criteria:Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)Malignant ascites at time of study enrollmentComorbidities that would preclude protocol therapySubjects deemed unable to comply with study and/or follow-up proceduresSubjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity