This phase II trial studies how well laparoscopic hyperthermic intraperitoneal chemoperfusion works in treating patients with peritoneal carcinomatosis from gastric or gastroesophageal cancer. Peritoneal carcinomatosis is a condition in which the cancer has spread to the peritoneum, the tissue that lines the wall of the abdomen and the abdominal organs. Heating a chemotherapy solution and infusing it directly into the abdomen (hyperthermic intraperitoneal chemoperfusion) may increase the effects of chemotherapy and kill more tumor cells.
Additional locations may be listed on ClinicalTrials.gov for NCT02092298.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric and gastroesophageal cancer and positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration.
SECONDARY OBJECTIVES:
I. To assess the safety of laparoscopic hyperthermic intraperitoneal chemotherapy administration for subjects with gastric and gastroesophageal cancer and positive cytology or imaging occult carcinomatosis.
II. To assess the gastric resection rate in subjects with stage IV gastric and gastroesophageal cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration.
OUTLINE:
At least 3 weeks after completion of systemic chemotherapy, patients undergo laparoscopic hyperthermic intraperitoneal chemoperfusion (HIPEC) comprising mitomycin and cisplatin over 60 minutes. Treatment may repeat every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. At least 2 weeks after HIPEC, patients without progression undergo diagnostic laparoscopy and possible exploratory laparotomy to assess resectability. Patients with resectable disease, undergo gastrectomy.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBrian D. Badgwell
