CT2 - A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology

Background Current national guidelines do not include hyperthermic intraperitoneal chemoperfusion (HIPEC) as treatment for gastric cancer, and there are no completed clinical trials of cytoreduction, gastrectomy, and HIPEC from the U.S. However, recent international studies report long-term survival rates of approximately 20% with cytoreduction/gastrectomy/HIPEC. Methods Patients with gastric adenocarcinoma and positive peritoneal cytology or carcinomatosis who had completed systemic chemotherapy and laparoscopic HIPEC underwent cytoreduction, gastrectomy, and HIPEC with 30 mg mitomycin C and 200 mg cisplatin. The primary end point was overall survival (OS), with secondary end points of safety and postoperative complications (NCT02891447). Results We enrolled 20 patients from 9/2016 to 3/2019, with a median age of 58 years (range, 20-75 years). Six patients had positive cytology only at diagnosis of stage IV disease, whereas 14 had carcinomatosis. All patients were treated with systemic chemotherapy with a median of 8 cycles (range, 5-11 cycles) and at least one laparoscopic HIPEC. The median peritoneal carcinomatosis index at cytoreduction/gastrectomy/HIPEC was 2 (range, 0-13). After surgery, the 90-day morbidity and mortality rates were 70% and 0%, respectively. Median length of hospital stay was 13 days (range, 7-23 days). Median follow-up was 1.8 years. Median OS from the date of diagnosis of metastatic disease was 2.1 years. Median OS from the date of cytoreduction, gastrectomy, and HIPEC was 1.4 years. One, 2, and 3-year OS rates from the diagnosis of metastatic disease are 90%, 54%, and 29%. Conclusions Survival rates for patients with gastric adenocarcinoma and peritoneal disease treated with cytoreduction, gastrectomy, and HIPEC are encouraging; our early results are similar to those of recent prospective registry studies. Multi-institutional and cooperative group trials should be supported and will be required to confirm survival and safety outcomes.