Title: Phase II Trial of heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology1
Principal Investigator: Jeremy L. Davis, MD, National Cancer Institute (NCI)
Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT03092518), researchers are investigating the efficacy of surgical resection plus heated intraperitoneal chemotherapy (HIPEC) for improving survival outcomes among patients with gastric cancer.
Patients will undergo surgery to excise as many gastric tumors as possible, then will receive intraperitoneal HIPEC with cisplatin 90 mg/m2 plus mitomycin C 10 mg/m2 over 90 minutes. Sodium thiosulfate continuous intravenous infusion will be initiated directly before chemotherapy and continued for 12 hours.
The primary outcome is median survival after surgery.
The estimated study enrollment is 40 patients.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03092518.
Status: Open and recruiting patients as of February 23, 2018.
This study is sponsored by the NCI.
- ClinicalTrials.gov. Heated intraperitoneal chemotherapy and gastrectomy for gastric cancer with positive peritoneal cytology. NCT03092518. https://clinicaltrials.gov/ct2/show/NCT03092518. Accessed February 23, 2018.