A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation
Status:
Recruiting
Trial end date:
2028-07-31
Target enrollment:
Participant gender:
Summary
Stomach cancer is the fifth most common digestive cancer and third main cause of death from
cancer in the world. Modern management of Gastric cancer involves a multi-disciplinary
approach involving surgical oncologists, medical oncologists, gastroenterologists and
oncological radiologists. The most common clinical approach to Gastric adenocarcinoma is to
begin with staging, which usually involves CT scan/ MRI combined with endoscopic US for more
accurate T, N staging. Once the patient is deemed to have locally advanced gastric cancer
(T3/T4,N0/+), a staging laparoscopy is recommended to rule out obvious or microscopic
peritoneal metastatic disease. Additionally, neoadjuvant chemotherapy is initiated and
followed by surgery +/- adjuvant radiation and chemotherapy.This protocol involves the
addition of neoadjuvant HIPEC at the time of diagnostic laparoscopy as well as neoadjuvant
radiation therapy for improved local and systemic control. The goal of this phase II clinical
trial is to evaluate the efficacy of a multi-modality approach to treating patients with
locally advanced Gastric cancer by incorporating diagnostic laparoscopy with HIPEC,
neo-adjuvant chemo-radiotherapy, followed by surgical resection and adjuvant chemotherapy.
The trial aims to assess this multi-modality approach in inducing pathological complete
response; decreased rates of disease progression during neoadjuvant therapy; and increased
overall, disease-free, and peritoneal disease-free survival.