Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer

INTERVENTION: S‐1 40mg/m2 is administered orally twice daily from day 1 to day 14 followed by a two‐week rest. Gemcitabine 1,000mg/m2 was administered as a 30‐min intravenous infusion on day 1 and 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal or unacceptable toxicity. Gemcitabine 1,000mg/m2 was administered as a 30‐min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal, or unacceptable toxicity. CONDITION: Advanced nonresectable pancreatic cancer PRIMARY OUTCOME: Progression‐free Survival; Overall Survival; Response Rate SECONDARY OUTCOME: Clinical Benefit Response; Tumor Marker; Adverse effects INCLUSION CRITERIA: The study is designed to enroll patients with nonresectable, pathologically proven, locally advanced or metastatic pancreatic cancer. Other eligibility criteria includes no prior therapy, performance status of 0‐2, age between 20 and 79 years, life expectancy more than 3 months, and adequate organ function defined as white blood cell count >=3,000/mm3;, platelet count>=100,000/mm3;, hemoglobin>=10g/dl, total and direct bilirubin <=2 times the upper limit of normal, AST and ALT <=5 times the upper limit of nomal, and creatinine <=1.5 times the upper limit of normal, creatinine clearance>=50ml/ml. Written informed consent is required from all patients.