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Spots Global Cancer Trial Database for A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

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Trial Identification

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

Conditions

Gastric Cancer

Study Description

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).

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Atsushi Ohtsu, MD

Affiliation: National Cancer Centr Hospital East

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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