Randomized phase III trial of adjuvant chemotherapy with gemcitabine versus S-1 in patients with resected pancreatic cancer: Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC-01).
作者： A. Maeda , N. Boku , A. Fukutomi , S. Kondo , T. Kinoshita
DOI: 10.1093/JJCO/HYM178
关键词: Pancreatic cancer 、 Gemcitabine 、 Every Four Weeks 、 Medicine 、 Every Six Weeks 、 Survival rate 、 Every Three Months 、 Pancreatectomy 、 Surgery 、 Every Six Months
摘要: A randomized controlled trial has begun in Japan to compare orally administered S-1 with intravenous gemcitabine (GEM) as adjuvant chemotherapy for patients curatively resected pancreatic cancer. Patients are enrolled within 10 weeks after pancreatectomy be treated six months assignment either (80 mg/m(2)/day four weeks, repeated similarly every a total of courses) or GEM (1000 mg/m(2) on days 1, 8 and 15, courses). The primary endpoint is overall survival; secondary endpoints include relapse-free survival, incidence adverse events health-related quality life. Each treatment arm includes 180 patients, providing an expected hazard ratio 0.87 upper margin 1.25 (two-sided alpha-error, 0.05; power, 0.8). Follow-up abdominal computed tomography three during the first two years, then years.
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