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

Inclusion Criteria

• •1. Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma.
• •2. No evidence of distant metastasis representing stage IV metastatic disease.
• •3. 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.
• •4. 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.
• •5. Age \> 18 years old
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •7. Patients must have adequate bone marrow function:
• •* Platelets \>100,000 cells/mm3
• •* Hemoglobin \> 9.0 g/dL
• •* Absolute Neutrophil Count \> 1,500 cells/mm3
• •8. Patients must have adequate liver function:
• •* aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2.5 X upper limit of normal
• •* Alkaline phosphatase \< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
• •* Total bilirubin \< 1.5 mg/dL
• •9. Patients must have adequate renal function: creatinine \<1.5 mg/dL is recommended; however, institutional norms are acceptable. Creatinine within institutional limits of normal or creatinine clearance (CrCl) \> 50 mL/min calculated using the Cockcroft-Gault equation.
• •10. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
• •11. Negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential.
• •12. Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE 4.03).
• •13. Ability to understand and willingness to sign a written informed consent.