HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrium Health; Carolinas Medical Center
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Primary diagnosis of pancreatic ductal adenocarcinoma (PDAC) confined to the head of the pancreas classified as T1-T3 with one or more of the following high-risk clinical features:

• Carbohydrate antigen (CA) 19-9 greater than 1,000 U/mL with a normal bilirubin;

• Vascular involvement; and/or

• Suspicious regional lymphadenopathy

• Intention to undergo open pancreaticoduodenectomy (standard Whipple or pylorus-preserving pancreaticoduodenectomy) as treatment for PDAC

• Adequate clinical condition to undergo preoperative (neoadjuvant) hyperthermic intraperitoneal chemotherapy

• Adequate clinical condition to undergo perioperative systemic chemotherapy

• White blood cell count of at least 3000/mL

• Platelet count of at least 100,000/mL

• Normal creatinine (< 2 mg/dL) or creatinine clearance of at least 50 mL/min

• Willing and able to give informed consent

Exclusion Criteria:

• Evidence of locoregional spread (carcinomatosis of peritoneal surfaces, mesenteric arteries, or body/tail of pancreas) or distant (liver, lung, or other) metastases (histological, CT, or MRI confirmation)

• Non-curative intent of treatment (≥R2 resection)

• Body mass index (BMI) > 35

• Previous history of pancreatic resections for tumors in the body and/or tail of the pancreas, distal cholangiocarcinoma, duodenal carcinoma, neuroendocrine tumors, cyst-adenocarcinoma, or solid and papillary tumors.

• Unstable or uncompensated respiratory or cardiac disease

• Severe hepatic or renal dysfunction

• Bleeding diathesis or coagulopathy

• Pregnant or nursing women