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Brief Title: A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
Official Title: 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)
Study ID: NCT00142350
Brief Summary: 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
Detailed Description: 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).
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Nagoya Medical Center, Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan
Aichi Cancer Center,Aichi Hospital, Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan
Aomori Prefectural Central Hospital, Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan
Chiba Cancer Center Hospital, Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
Asahi General Hospital, I-1326,Asahi, Chiba, Japan
National Cancer Center Hospital East, Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama,Horinouchi,13, Ehime, Japan
Kyushu University Hospital, Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
National Kyushu Cancer Center, Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
Federation of national public service personnel mutual aid associations Tonan Hospital, kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan
Hokkaido University Hospital, North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Hyogo Medical Center for Adults, Akashi,Kitaouji-cho,13-70, Hyogo, Japan
Kobe University Graduate School of Medicine, Kobe,Chuo-ku,Kusunoki-cho,7-5-2, Hyogo, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center, Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Iwate Prefectural Central Hospital, Morioka,Ueda,1-4-1, Iwate, Japan
Kitasato University East Hospital, Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Yokohama Mucipical Citizen's Hospital, Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, Japan
Yokohama City University Medical Center, Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan
Kochi Health Science Center, Kochi,Ike,2125-1, Kochi, Japan
Kumamoto Regional Medical Center Hospital, Kumamoto,Honjo,5-16-10, Kumamoto, Japan
Kyoto University Hospital, Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan
Tohoku University Hospital, Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Saku Central Hospital, Saku,Usuda,197, Nagano, Japan
Osaka Medical College, Takatsuki,Daigakucho,2-7, Osaka, Japan
Saitama Medical School Hospital, Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan
Saitama Cancer Center, Kita-adachi,Ina,Komuro,818, Saitama, Japan
Div. of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Nagaizumi-cho, Shimonagakubo,1007, Shizuoka, Japan
Tochigi Cancer Center, Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
National Cancer Center Hospital, Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Cancer Institute Hospital, Koto-ku,Ariake,3-10-6, Tokyo, Japan
Showa University School of Medicine, Shinagawa-ku,Hatanodai,1-5-8, Tokyo, Japan
Yamagata Prefectural Central Hospital, Yamagata,Aoyagi,1800, Yamagata, Japan
Name: Atsushi Ohtsu, MD
Affiliation: National Cancer Centr Hospital East
Role: STUDY_CHAIR