A clinical phase-II trial of neoadjuvant chemoradiotherapy with S-1 and Gemcitabine for locally advanced pancreatic cancer (PerSeUS-GP02)

INTERVENTION: After chemoradiation therapy with S‐1 and Gemcitabine, surgical resection is carried out. Post operative chemotherapy with S‐1 is continued for 1 year. S‐1; 80mg/m2/day (administration on the day of radiation therapy) Gemcitabine; 1000mg/m2/day, day1, 15, 29 Radiation therapy; a total dose of 39.6Gy by 22 fractions. Post operative chemotherapy with S‐1: S‐1; 80mg/m2 administration for 14 days, followed by a resting period for 7 days. CONDITION: Locally advanced pancreatic cancer PRIMARY OUTCOME: 1‐year survival rate SECONDARY OUTCOME: Progression free survival; Surgical resection rate; Curative resection rate; Response rate; Safety INCLUSION CRITERIA: 1. Histologically, cytologically or radiographically proven pancreatic cancer 2. Stage IVa borderline resectable pancreatic cancer defined in NCCN guidelines 2012 pancreatic adenocarcinoma 3. At least one measurable lesion 4. No prior history of the treatment such as surgical operation, radiotherapy, and chemotherapy for the lesion 5. ECOG performance status of 0‐1. 6. Adequate oral intakes 7. Sufficient organ function: Leukocytes: >= 3,500/mm3 Neutrophil: >= 2,000/mm3 Platelets: >= 100,000/mm3 Hemoglobin: >= 9g/dL Serum total bilirubin: <= 2.0mg/dL (or 3.0mg/dL in cases after biliary drainage) Serum transaminases: AST <= 100U/L (or 150U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases after biliary drainage) Serum creatinine: <= 1.2mg/dL Creatinine clearance: >= 50ml/min (option) 8. Life expectancy of more than 3 months 9. Written informed consent