A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer

INTERVENTION: S‐1 60mg/m2/day is administered orally twice daily from the evening of day 1 to the morning of day 15 followed by a one week rest. Gemcitabine 1000mg/m2 was administered in a 30‐min intravenous infusion on days 8 and 15 of each cycle. The cycle was repeated every 21 days until disease progression. Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression. CONDITION: pancreatic cancer PRIMARY OUTCOME: progression free survival INCLUSION CRITERIA: (1)Histopathologically proven advanced pancreatic cancer (2)20 ‐ 79 years of age, (3)ECOG PS 0 or 1 (4)No prior chemotherapy or radiotherapy (5)Oral intake is possible (6)Written informed consent (7)Adequate organ function