Spots Global Cancer Trial Database for Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
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Trial Identification
Brief Title: Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
Official Title: Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer
Study ID: NCT00639327
Conditions
Study Description
Brief Summary: The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.
Detailed Description: Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line. In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1. Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Midori Municipal Hospital, Nagoya, Aichi, Japan
Nagoya City University Hospital, Nagoya, Aichi, Japan
Yamamoto Hospital, Noshiro, Akita, Japan
Hirosahi University Graduate School of Medicine, Hirosaki, Aomori, Japan
University of Fukui Faculty of Medical Scieneces Hospital, Yoshida-gun, Fukui, Japan
Nippon Steel Yawata Memorial Hospital, Kitakyusyu, Fukuoka, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
Gunma University Hospital, Maehashi, Gunma, Japan
Gunma Prefectural Cancer Center, Oota, Gunma, Japan
Fukuyama City Hospital, Fukuyama, Hiroshima, Japan
Asahikawa Medical College Department Medicine, Asahikawa, Hokkaido, Japan
Asahikawa Medical College Hospital, Asahikawa, Hokkaido, Japan
Hakodate Goryoukaku Hopsital, Hakodate, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan
Hyogo Prefectural Awaji Hospital, Sumoto, Hyogo, Japan
Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan
Kanazawa Medical University Hospital, Kawakita, Ishikawa, Japan
Iwate Prefectural Central Hospital, Morioka, Iwate, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Kagawa Medical University Hospital, Kida, Kagawa, Japan
Kirishima Medical Center, Kirishima, Kagoshima, Japan
Tokai University Hospital, Isehara, Kanagawa, Japan
St.Marianna University School Of Medicine Hospital, Kawasaki, Kanagawa, Japan
Showa University Northern Yokohama Hospital, Yokohama, Kanagawa, Japan
Showa University Fujigaoka Hospital, Yokohama, Kanagawa, Japan
Citizen's General Medical Center attached to Yokohama City University, Yokohama, Kanagawa, Japan
Miyagi Cancer Center, Natori, Miyagi, Japan
Institute of Development,Aging and Cancer,Tohoku University, Sendai, Miyagi, Japan
Tohoku University School Of Medicine, Sendai, Miyagi, Japan
Sendai Medical Center, Sendai, Miyagi, Japan
Kaneda Hospital, Maniwa, Okayama, Japan
Rinku General Medical Center, Izumisano, Osaka, Japan
Kimen Municipal Hospital, Kimen, Osaka, Japan
Sakai Municipal Hospital, Sakai, Osaka, Japan
Osaka Rosai Hospital, Sakai, Osaka, Japan
Suita Municipal Hospital Website, Suita, Osaka, Japan
Yao City Hospital, Yao, Osaka, Japan
Saiseikai Shiga Hospital, Ritto, Shiga, Japan
Shimane University Faculty of Medicine, Izumo, Shimane, Japan
Matsue City Hospital, Matsue, Shimane, Japan
Dokkyo University School of Medecine, Shimotsuga, Tochigi, Japan
Nippon Medical School, Bunkyo-ku, Tokyo, Japan
Surugadai Nihon University Hospital, Chiyoda-ku, Tokyo, Japan
Teikyo University Hospital, Itabashi-ku, Tokyo, Japan
Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan
Toho University Ohhashi 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
Toho University Omori Medical Center, Oota-ku, Tokyo, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Institute of Gastorenterology, Shinjuku-ku, Tokyo, Japan
Metropolitan Bokutoh Hospital, Sumida-ku, Tokyo, Japan
Tottori University Faculty of Medicine, Yonago, Tottori, Japan
Saiseikai Takaoka Hospital, Takaoka, Toyama, Japan
Kouseiren Takaoka Hospital, Takaoka, Toyama, Japan
Aichi Medical University Hospital, Aichi, , Japan
Nakadoori General Hospital, Akita, , Japan
Aomori Prefectural Central Hospital, Aomori, , Japan
ChibaUniversity Hospital, Chiba, , Japan
Fukui Red Cross Hospital, Fukui, , Japan
Saiseikai Hospital, Fukui, , Japan
Saiseikai Fukuoka General Hospital, Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center, Fukuoka, , Japan
National Kyusyu Cancer Center, Fukuoka, , Japan
Kyusyu University Faculty of Medical Sciences, Fukuoka, , Japan
Fukushima Medical University, Fukushima, , Japan
Gifu Municipal Hospital, Gifu, , Japan
Gifu Prefectural General Medical Center, Gifu, , Japan
Graduate School of Medicine, Gifu University, Gifu, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery, Hiroshima, , Japan
National Hospital Organization Kagoshima Medical Center, Kagoshima, , Japan
Kochi Health Sciences Center, Kochi, , Japan
Kumamoto Medical University Hospital, Kumamoto, , Japan
Nagano Municipal Hospital, Nagano, , Japan
Niigata Prefectural Cancer Center, Niigata, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
Kitano Hospital, Osaka, , Japan
Osaka City University Graduate School of Medicine, Osaka, , Japan
Osaka Koseinenkin Hospital, Osaka, , Japan
Osaka General Medical Center, Osaka, , Japan
Saga Prefectural Hospital Kouseikan, Saga, , Japan
Toyama Prefectural Center Hospital, Toyama, , Japan
Yamagata University Faculty Of Medicine, Yamagata, , Japan
Contact Details
Name: Masashi Fujii, M.D.,PhD
Affiliation: Surugadai Nihon University Hospital
Role: PRINCIPAL_INVESTIGATOR
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