This phase II trial tests how well concentrating heated (hyperthermic) chemotherapy in the area that contains the abdominal organs (intraperitoneal [IP]) at the time of surgery works in treating patients with gastric or gastroesophageal junction adenocarcinoma at high risk of the cancer coming back to the abdominal cavity (peritoneal) after a period of improvement (recurrence). Recurrence in the peritoneum often occurs within the first 18 months after surgery. This is thought to be due to tumor cells that may scatter and spread during surgery. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Paclitaxel alone and in combination with other chemotherapy agents have been shown to be effective treatments for gastric tumors. However, systemic delivery of these drugs has not been shown to be effective in treating peritoneal metastasis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure that involves the infusion of a heated chemotherapy solution, such as cisplatin and paclitaxel, that circulates into the abdominal cavity. Giving HIPEC with cisplatin and paclitaxel at the time of surgery may reduce peritoneal recurrence in patients with gastric or gastroesophageal junction adenocarcinoma at high risk.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07139951.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Travis Edward Grotz
Phone: 507-284-2511
PRIMARY OBJECTIVE:
I. To evaluate the reduction in the peritoneal recurrence at 18 months for patients receiving prophylactic (p)-HIPEC.
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of the p-HIPEC specifically, the incidence of (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5) grade 3 neutropenia, thrombocytopenia, and the incidence of acute kidney injury (defined by the glomerular filtration rate [GFR] criteria of the RIFLE [Risk, Injury, Failure,Loss of kidney function and End-stage kidney disease]) classification.
II. To compare the operative time, estimated blood loss, hospital length of stay, incidence of 30- day and 90- day complications, 90-day readmission rate, 90- day reoperation rate, 90- day mortality rate to recent historical controls treated without p-HIPEC.
III. To investigate the 3-, and 5-year overall survival (OS) following p-HIPEC.
TERTIARY AND CORRELATIVE OBJECTIVE:
I. To biobank blood and gastric primary tumor specimens for organoid studies for drug testing and multiomic studies such as multiplex imaging studies.
OUTLINE:
Patients undergo gastrectomy with reconstruction per surgeon discretion and D2 lymphadenectomy and receive p-HIPEC with cisplatin and paclitaxel IP over 90 minutes on study. Patients also undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) throughout the study, as well as laparoscopy with biopsy during screening.
After completion of study treatment, patients are followed at 45 days, at 3, 6, 12 and 18 months, every 3 months for up to 3 years and at 5 years.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorTravis Edward Grotz
