Gastric Adenocarcinoma Clinical Trial
Official title:
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
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.
PRIMARY OBJECTIVE: I. To assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy. SECONDARY OBJECTIVES: I. To obtain a biorepository for additional translational research including: Ia. Stool samples for shotgun metagenomic sequencing and metabolomic quantification of the fecal microbiome before and after gastrectomy; Ib. Blood and peritoneal tissue biobanked for future investigations; Ic. Patient reported outcomes using the Mayo Clinic Upper Digestive Disease Survey questionnaires at 1, 3, 6 and 12 months. OUTLINE: Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT scans throughout the trial. ;
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