Spots Global Cancer Trial Database for Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
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Trial Identification
Brief Title: Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
Official Title: A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
Study ID: NCT00287768
Conditions
Study Description
Brief Summary: The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.
Detailed Description: Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of subjects alive 5 years after diagnosis. Therefore, new treatment regimens are needed for subjects with AGC. S-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO) is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 is active, as a single agent, for the treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers. In gastric cancer, phase III trials (JCOG 9912) comparing 5-FU alone and CPT-11/CDDP combination are currently underway and these results are awaited. Despite of JCOG 9912 study is ongoing, 80% of patients of AGC are already treated by S-1, because of high RR and convenience use for out-patient basis. P-II studies S-1/CDDP, S-1/CPT-11 and S-1/Docetaxel showed high RR(55-76%) and long MST(12-14M). Furthermore, P-III studies are already conducted S-1 vs. S-1/CDDP and S-1 vs. S-1/CPT-11 in Japan. The aim of this study is to compare S-1/Docetaxel vs. S-1 alone in the patients of AGC. This study is a prospective, multicenter, multinational, non-blinded, randomized phase III study. Patients: Inoperable or relapse gastric cancer. Informed consent must be obtained in writing before treatment. Subjects meeting all of the inclusion criteria and exclusion criteria will be considered for enrollment into study. Then patients will be randomly assigned into two groups S-1/Docetaxel(Treatment Arm A) or S-1 alone(Treatment Arm B).
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center, Nagoya, Aichi, Japan
Hirosahi University Graduate School of Medicine, Hirosaki, Aomori, Japan
Hirosaki Unuversity,School of Medicine, Hirosaki, Aomori, Japan
Misawa City Hospital, Misawa, Aomori, Japan
Matsuyama Simin Hospital, Matsuyama, Ehime, Japan
Iizuka Hospital, Iizuka, Fukuoka, Japan
Nippon Steel Yawata Memorial Hospital, Kitakyusyu, Fukuoka, Japan
Universsity of Occupational and Environmental Health,Japan, Kitakyusyu, Fukuoka, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
Ibi Kose Hospital, Ibi, Gifu, Japan
Gunma University Hospital, Maehashi, Gunma, Japan
Gunma Prefectural Cancer Center, Oota, Gunma, Japan
Fukuyama City Hospital, Fukuyama, Hiroshima, Japan
National Hospital Organization Kure Medical Center, Kure, Hiroshima, Japan
Asahikawa-Kosei General Hospital, Asahikawa, Hokkaido, Japan
Asahikawa Medical College Hospital, Asahikawa, Hokkaido, Japan
Hakodate Goryoukaku Hopsital, Hakodate, Hokkaido, Japan
Kushiro City General Hospital, Kushiro, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Kinki Central Hospital, Itan, Hyogo, Japan
Kobe University Hospital, Kobe, Hyogo, Japan
Hyogo College Of Medicine, Nishimiya, Hyogo, Japan
Hitachi General Hospital, Hitachi, Ibaragi, Japan
Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan
Kanazawa Medical School Hospital, Kanazawa, Ishikawa, Japan
Kanazawa Medical University Hospital, Kawakita, Ishikawa, Japan
Keiju Medical Center, Nanao, Ishikawa, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Morioka Red Cross Hospital, Morioka, Iwate, Japan
Tokai Medical University Hospital, Isehara, Kanagawa, Japan
St.Marianna University School of Medicine, Kawasaki, Kanagawa, Japan
Kitasato University East Hospital, Sagamihara, Kanagawa, Japan
Showa University Fujigaoka Hospital, Yokohama, Kanagawa, Japan
Yokohama Citizen's Municipal Hospital, Yokohama, Kanagawa, Japan
St. Marianna University School of Medicine,Yokohama City Seibu Hospital, Yokohama, Kanagawa, Japan
Kanagawa Prefectural Cancer Center, Yokohama, Kanagawa, Japan
Showa University Northern Yokohama Hospital, Yokohama, Kanagawa, Japan
Tohoku Rosai Hospital, Sendai, Miyagi, Japan
Institute of Development,Aging and Cancer,Tohoku University, Sendai, Miyagi, Japan
Hokushin Synthesis Hospital, Nakano, Nagano, Japan
National Hospital Organization Nagasaki Medical Center, Oomura, Nagasaki, Japan
Nara Medical University Hospital, Kashihara, Nara, Japan
Kaneda Hospital, Maniwa, Okayama, Japan
Hospital, University of the Ryukyus, Chutougun, Okinawa, Japan
Rinku General Medical Center, Izumisano, Osaka, Japan
Kimen Municipal Hospital, Kimen, Osaka, Japan
Sakai Municipal Hospital, Sakai, Osaka, Japan
Kinki Medical University Hospital, Sayama, Osaka, Japan
Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan
Yao Municipal Hospital, Yao, Osaka, Japan
Otsu Municipal Hospital, Otsu, Shiga, Japan
Saiseikai Shiga Hospital, Ritto, Shiga, Japan
Shimane University Faculty of Medicine, Izumo, Shimane, Japan
Takarazuka City Hospital, Hyogo, Takarazuka, Japan
Jichi Medical School Hospital, Shimono, Tochigi, Japan
Dokkyo University School of Medecine, Shimotsuga, Tochigi, Japan
Tokushima Red Cross Hospital, Komatsushima, Tokushima, Japan
Tokyo Medical and Dental University Hospital Faculty of Medicine, Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Komagome Hospital, Bunkyo-ku, Tokyo, Japan
Surugadai Nihon University Hospital, Chiyoda-ku, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan
Teikyo University Hospital, Itabashi-ku, Tokyo, Japan
Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan
Cancer Institute Hospital, Koto-ku, Tokyo, Japan
Japan Clinical Cancer Research Organization, Koto-ku, Tokyo, Japan
Showa University Toyosu Hospital, Koto-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center, Meguro-ku, Tokyo, Japan
Toho University Ohashi Medical Center, Meguro-ku, Tokyo, Japan
Toranomon Hospital, Minato-ku, Tokyo, Japan
The Jikei University, Minato-ku, Tokyo, Japan
International University of Health and Welfare Mita Hospital, Minato-ku, Tokyo, Japan
Kyorin University Hospital, Mitaka, Tokyo, Japan
Showa University Hospital, Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
International Medical Center of Japan, Shinjuku-ku, Tokyo, Japan
Social Insurange Central General Hospital, Shinjuku-ku, Tokyo, Japan
Tottori University Faculty of Medicine, Yonago, Tottori, Japan
Kouseiren Takaoka Hospital, Takaoka, Toyama, Japan
Yamanashi Prefectural Central Hospital, Kohfu, Yamanashi, Japan
Aichi Medical University Hospital, Aichi, , Japan
Akita University Hospital, Akita, , Japan
Nakadoori General Hospital, Akita, , Japan
Aomori Prefectural Central Hospital, Aomori, , Japan
Department of frontier surgery Graduate school of medicine,Chiba University, Chiba, , Japan
Department of Organ kegulatory Surgery (First Department Surgery),Ehime University Graduate School of Medicine, Ehime, , Japan
Fukui Prefectural Hospital, Fukui, , Japan
Fukui Red Cross Hospital, Fukui, , Japan
Saiseikai Hospital, Fukui, , Japan
Saiseikai Fukuoka General Hospital, Fukuoka, , Japan
National Kyusyu Cancer Center, Fukuoka, , Japan
Kyusyu University Faculty of Medical Sciences, Fukuoka, , Japan
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Gifu Municipal Hospital, Gifu, , Japan
Gifu University School of Medicine, Gifu, , Japan
Gifu Prefectural Gifu Hospital, Gifu, , Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, , Japan
Horoshima City Asa Hospital, Hiroshima, , Japan
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery, Hiroshima, , Japan
Department of surgical oncology and digestive surgery kagoshima university graduate school, Kagoshima, , Japan
Kochi Health Sciences Center, Kochi, , Japan
Kumamoto Medical University Hospital, Kumamoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
University Hospital,Kyoto Prefectural University of Medicien, Kyoto, , Japan
Nagano Municipal Hospital, Nagano, , Japan
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, , Japan
National Hospital Organization Nagoya Medical Center, Nagoya, , Japan
Niigata Prefectural Cancer Center, Niigata, , Japan
Oita Prefectural Hospital, Oita, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Osaka City University Graduate School of Medicine, Osaka, , Japan
Osaka General Medical Center, Osaka, , Japan
Saga Medical School Hospital, Saga, , Japan
Yamagata Prefectural Central Hospital, Yamagata, , Japan
Contact Details
Name: Masashi Fujii, MD PhD
Affiliation: Surugadai Nihon University Hospital
Role: PRINCIPAL_INVESTIGATOR
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