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Brief Title: Elderly NSCLC/D vs DP (JCOG0207)
Official Title: Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
Study ID: NCT00190476
Brief Summary: To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Detailed Description: The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination. Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Cancer Center Hospital, Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Aichi Cancer Center,Aichi Hospital, Okazaki,Kake-machi,Kuriyado,18, 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
Kyushu University Hospital, Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
Gifu Municipal Hospital, Gifu,Kashima-cho,7-1, Gifu, Japan
Gunma Prefectural Cancer Center, Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
National Nishigunma Hospital, Shibukawa,Kanai,2854, Gunma, Japan
National Hospital Organization, Dohoku National Hospital, Asahikawa,Hanasaki,7-4048, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan
Hyogo Medical Center for Adults, Akashi,Kitaouji-cho,13-70, Hyogo, Japan
Hyogo College of Medicine, Nishinomiya,Mukogawa-cho,1-1, Hyogo, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center, Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 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
Kumamoto Regional Medical Center Hospital, Kumamoto,Honjo,5-16-10, Kumamoto, Japan
Niigata Cancer Center Hospital, Niigata,Kawagishi-cho, 2-15-3, Niigata, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease, Habikino,Habikino,3-7-1, 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
Kinki University School of Medicine, Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai,Nagasone,1180, Osaka, Japan
National Hospital Organization Toneyama National Hospital, Toyonaka,Toneyama,5-1-1, Osaka, Japan
Saitama Cancer Center, Kita-adachi,Ina,Komuro,818, Saitama, Japan
Sizuoka 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
International Medical Center of Japan, Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Yamagata Prefectural Central Hospital, Yamagata,Aoyagi,1800, Yamagata, Japan
Name: Akira Yokoyama, MD, PhD
Affiliation: Department of Internal Medicine, Niigata Cancer Center Hospital
Role: STUDY_CHAIR