Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).
Inclusion Criteria:
Exclusion Criteria:
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken 460-0001, Japan
Kashiwa,Kashiwanoha,6-5-1, Chiba 277-8577, Japan
Matsuyama,Horinouchi,13, Ehime 790-0007, Japan
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka 812-8582, Japan
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka 811-1395, Japan
Kita 1 Nishi 6,Chuo-ku,Sapporo, Hokkaido 060-0001, Japan
Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyōgo 650-0017, Japan
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki 309-1793, Japan
Sagamihara,Asamizodai,2-1-1, Kanagawa 228-8520, Japan
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa 241-0815, Japan
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa 240-8555, Japan
Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa 232-0024, Japan
Kumamoto,Honjo,5-16-10, Kumamoto 860-0811, Japan
Saku,Usuda,197, Nagano 384-0301, Japan
Kita-adachi,Ina,Komuro,818, Saitama 362-0806, Japan
Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka 411-8777, Japan