Spots Global Cancer Trial Database for A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
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Trial Identification
Brief Title: A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
Official Title: Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
Study ID: NCT00190515
Conditions
Study Description
Brief Summary: To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.
Detailed Description: Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer. UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks. 5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks. Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.
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
Fujita Health University, Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan
Chiba Cancer Center Hospital, Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
National Cancer Center Hospital East, Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Toho University Sakura Hospital, Sakura,Shimoshidu,564-1, Chiba, Japan
Jyuntendo Urayasu Hospital, Urayasu,Tomioka,2-1-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama,Horinouchi,13, Ehime, Japan
National Kyushu Cancer Center, Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
Kurume University School of Medicine, Kurume,Asahi-machi,67, Fukuoka, Japan
Kurume University Medical Center, Kurume,Kokubumachi,155-1, Fukuoka, Japan
Gunma Prefectural Cancer Center, Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
Hiroshima University, School of Medicine, Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan
Hiroshima City Hospital, Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan
Sapporo-Kosei General Hospital, North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan
Kansai Rosai Hospital, Amagasaki,Inabasou,3-1-69, Hyogo, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center, Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Ishikawa Prefectual Central Hospital, Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan
Teikyo University Hospital, Mizonokuchi, Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan
Kitasato University East Hospital, Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan
Kitasato University School of Medichine, Sagamihara,Kitasato,1-15-1, Kanagawa, Japan
Yokohama City University Medical Center, Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama,Nakao,Asahi-ku,1-1-2, Kanagawa, Japan
Showa University Northern Yokohama Hospital, Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan
National Hospital Organization Kyoto Medical Center, Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan
Miyagi Cancer Center, Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
Nagano Municipal Hospital, Nagano,Tomitake,1333-1, Nagano, Japan
Niigata Cancer Center Hospital, Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Oita University Fuculty of Medicine, Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan
Okayama Saiseikai General Hospital, Okayama,Ifukucho,1-17-18, Okayama, Japan
Minoh City Hospital, Minoh,Kayano,5-7-1, Osaka, Japan
Osaka National Hospital, Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Osaka City General Hospital, Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan
Sakai Municipal Hospital, Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Osaka University Graduate School of Medicine, Suita,Yamada-oka,2-2, Osaka, Japan
Osaka Medical College, Takatsuki,Daigakucho,2-7, Osaka, Japan
Omiya Medical Center, Jichi Medical School, Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan
National Defense Medical College, Tokorozawa,Namiki,3-2, Saitama, Japan
Sizuoka Cancer Center, Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
Tochigi Cancer Center, Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
Tokyo Medical and Dental University Hospital, Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tsukiji, 5-1-1, Tokyo, Japan
Toho University Ohashi Hospital, Meguro-ku,Ohashi,2-17-6, Tokyo, Japan
Toranomon Hospital, Minato-ku,Toranomon,2-2-2, Tokyo, Japan
Kyorin University School of Medicine, Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Tokyo Medical University, Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan
Keio University Hospital, Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
Yamagata Prefectural Central Hospital, Yamagata,Aoyagi,1800, Yamagata, Japan
Contact Details
Name: Yoshihiro Moriya, MD
Affiliation: National Cancer Center Hospital
Role: STUDY_CHAIR
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