Clinical trialPhase 2Withdrawn
HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma
Hyperthermic Intraperitoneal Chemotherapy as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma: A Prospective, Phase II, Proof-of-concept Study
- Outcome
- Stopped earlyno accrual rate (Enrollment)
- Phase
- Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- February 2016
- Expected end
- December 2016
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Peritoneal disease-free survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 27 April 2022
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Brief summary public domain (ClinicalTrials.gov)
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.