Spots Global Cancer Trial Database for A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
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Trial Identification
Brief Title: A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
Official Title: Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)
Study ID: NCT00252161
Conditions
Study Description
Brief Summary: The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.
Detailed Description: A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.
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
National Cancer Center Hospital East, Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama,Horinouchi,13, Ehime, Japan
Gifu Municipal Hospital, Gifu,Kashima-cho,7-1, Gifu, Japan
Hiroshima City Hospital, Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan
Itami City Hospital, Itami,Koyaike,1-100, Hyogo, Japan
Iwate Medical University, Morioka,Uchimaru,19-1, Iwate, Japan
Kagoshima University,Faculty of Medicine, Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan
Kanagawa Cancer Center, Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Kyoto Second Red Cross Hospital, Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan
Miyagi Cancer Center, Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
National Hospital Organization, Sendai Medical Center, Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan
Nagaoka Chuo General Hospital, Nagaoka,Kawasaki,2041, Niigata, Japan
Niigata Cancer Center Hospital, Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Tsubame Rosai Hospital, Tsubame,Sawatari,633, Niigata, Japan
Oita University Fuculty of Medicine, Oita,Hasama-machi,Oogaoka,1-1, Oita, 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
Kinki University School of Medicine, Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
Sakai Municipal Hospital, Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Osaka Medical College, Takatsuki,Daigakucho,2-7, Osaka, Japan
Toyonaka Municipal Hospital, Toyonaka,Shibaharacho,4-14-1, Osaka, Japan
Saitama Cancer Center, Kita-adachi,Ina,Komuro,818, Saitama, Japan
National Defense Medical College, Tokorozawa,Namiki,3-2, Saitama, Japan
Shizuoka General Hospital, Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan
Tokyo Metropolitan Komagome Hospital, Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 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
Cancer Institute Hospital, Koto-ku,Ariake,3-10-6, Tokyo, Japan
International Medical Center of Japan, Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital, Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan
Toyama Prefectural Central Hospital, Toyama,nishinagae,2-2-78, Toyama, Japan
Wakayama Medical University, School of Medicine, Wakayama,Kimiidera,811-1, Wakayama, Japan
Yamagata Prefectural Central Hospital, Yamagata,Aoyagi,1800, Yamagata, Japan
Contact Details
Name: Mitsuru Sasako, MD, PhD
Affiliation: Hyogo Medical University
Role: STUDY_CHAIR
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