HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma
Status:
Withdrawn
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This single-center, prospective proof-of-concept study is designed to evaluate the surgical
outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal
chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT;
neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients
having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk
clinical features. The investigators hypothesize that HIPEC administered in this clinical
course will reduce postoperative peritoneal disease recurrence. The investigators also expect
that local recurrence of disease will be reduced. The primary aim of this study is to compare
2-year peritoneal disease-free survival between patients receiving the experimental therapy
(neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy (SCT +
PD). Secondary aims are to determine the clinical feasibility and outcomes of neoadjuvant
HIPEC for resectable PDAC using patient demographics and disease characteristic data.