Phase 1 Study of Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer
Researchers are evaluating the feasibility and safety of adjuvant HIPEC in patients with locally advanced gastric cancer.
Title: Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer1
Principal Investigator: Maheswari Senthil, MD, Loma Linda University Cancer Center
Description: For this open-label phase 1 study (ClinicalTrials.gov Identifier: NCT02672865), researchers are evaluating the feasibility and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with locally advanced gastric cancer.
Eligible patients will have their abdominal cavity bathed in a 40° to 42° Celsius solution of mitomycin 15 mg/m2 and cisplatin 50 mg/m2 for 90 minutes after surgical resection.
The primary outcome is post-operative complications, for which patients will be monitored for 90 days. A modified Clavien-Dindo classification will be used to grade any complications that occur.
The estimated study enrollment is 15 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02672865.
Status: Open and recruiting patients as of December 15, 2017.
This study is sponsored by Loma Linda University.
- ClinicalTrials.gov. Adjuvant hyperthermic intraperitoneal chemotherapy for locally advanced gastric cancer. NCT02672865. https://clinicaltrials.gov/ct2/show/NCT02672865. Accessed December 15, 2017.