Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Inclusion Criteria

• Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma.
• No evidence of distant metastasis representing stage IV metastatic disease.
• R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture.
• BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short-segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall.
• Age > 18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients must have adequate bone marrow function:
• Platelets >100,000 cells/mm3
• Hemoglobin > 9.0 g/dL
• Absolute Neutrophil Count > 1,500 cells/mm3
• Patients must have adequate liver function:
• aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) 50 mL/min calculated using the Cockcroft-Gault equation.
• Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
• Negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential.
• Patients must have grade 1).
• Patients with clinically significant cardiac disease (New York Heart Association Classification III or IV and cardiac arrhythmias not well controlled with medication), or myocardial infarction within the previous six months.
• Serious, uncontrolled, concurrent infection(s) requiring antibiotics.
• Pregnant or breastfeeding women: positive pregnancy test within 7 days of starting treatment.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• Patients with external biliary drains.