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Clinical Trial Questions?
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Study of Identification of Prognostic Factors in Patients With Curatively Resected Stage II Colon Cancer Receiving Adjuvant Chemotherapy With Tegafur-Uracil
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Biomarker/Laboratory analysis | Active | 20 to 75 | TMDU-BRI-CC-05-02
BRI-CC-05-02, NCT00898846 |
Objectives - Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.
- Identify predictive factors of chemosensitivity to this regimen in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma of the colon or rectosigmoid
- Must be registered on clinical trial TMDU-BRI-CC-05-01
- Must have resected tumor tissue available
- No hereditary colorectal cancer
Prior/Concurrent Therapy:
Patient Characteristics:
- ECOG performance status 0-1
Expected Enrollment 1000Outcomes Primary Outcome(s)Prognostic factors
Predictive factors of chemosensitivity
Outline Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.
Trial Contact Information
Trial Lead Organizations Tokyo Medical and Dental University | | | | Kenichi Sugihara, MD, PhD, Protocol chair | | | |
Trial Sites
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| Japan |
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Osaka |
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| | | | Osaka Red Cross Hospital |
| | | Akiyoshi Kanazawa, MD, PhD | |
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| Aichi |
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Nagoya |
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| | | | Ban Buntane Houtokukai Hospital |
| | | Satoshi Arakawa, MD | |
| | | Nagoya Ekisaikai Hospital |
| | | Hiroshi Kohno, MD | |
| | | Nagoya Midori Municipal Hospital |
| | | Takuji Fukui, MD, PhD | |
| | | Nagoya University Hospital |
| | | Yasuhiro Kodera, MD | |
| | Email:
ykodera@med.nagoya-u.ac.jp |
| | | Nagoya University School of Medicine |
| | | Norihiko Yuasa, MD, PhD | |
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Okazaki |
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| | | Aichi Prefectural Hospital |
| | | Contact Person | |
| | Email:
matsui-ngy@umin.ac.jp |
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| Akita |
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Noshiro |
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| | | | Yamamoto Kumiai General Hospital |
| | | Kenichi Oyama, MD | |
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Yokote |
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| | | Hiraka General Hospital |
| | | Contact Person | |
| | Email:
fcl3btkai@yahoo.co.jp |
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| Chiba |
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Chiba |
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| | | | Chiba Cancer Center |
| | | Contact Person | |
| | Email:
miyahide@faculty.chiba-u.jp |
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Ichihara |
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| | | Teikyo University Chiba Medical Center |
| | | Toru Tezuka, MD, PhD | |
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Inba-gunn |
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| | | Asahi General Hospital |
| | | Noritake Tanaka, PhD | |
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| Fukui |
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Fukui-shi |
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| | | | Fukuiken Saiseikai Hospital |
| | | Yoshinori Munemoto, MD | |
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Yoshida-gun |
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| | | University of Fukui Hospital |
| | | Akio Yamaguchi, MD, PhD | |
| | Email:
akio@u-fukui.ac.jp |
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| Fukuoka |
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Fukuoka |
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| | | | National Hospital Organization Kyushu Medical Center |
| | | Tetsuya Kusumoto, MD, PhD | |
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Fukuoka-shi |
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| | | Kyushu University Hospital |
| | | Yoshihiko Maehara, MD, PhD | |
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Kitakyushu |
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| | | Kitakyushu Municipal Medical Center |
| | | Yoshitaka Tanabe | |
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Kurume |
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| | | Kurume University School of Medicine |
| | | Kazuo Shirouzu, MD, PhD | |
| | Email:
skazuo@med.kurume-u.ac.jp |
| | | Saint Mary's Hospital |
| | | Satoshi Taniwaki, MD | |
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Tagawa |
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| | | Social Insurance Tagawa Hospital |
| | | Takaho Tanaka, MD, PhD | |
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| Fukushima |
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Fukushima-shi |
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| | | | Fukushima Medical University Hospital |
| | | Shinji Ohki, MD, PhD | |
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| Gifu |
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Gifu |
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| | | | Matsunami General Hospital |
| | | Kenji Kobayashi, MD | |
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Gifu-shi |
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| | | Gifu Municipal Hospital |
| | | Hiroo Oshita, MD | |
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Hashima |
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| | | Hashima City Hospital |
| | | Mikio Yasumura, MD, PhD | |
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Ogaki-shi |
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| | | Ogaki Municipal Hospital |
| | | Masatoshi Isogai, MD, PhD | |
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| Gunma |
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Maebashi-shi |
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| | | | Gunma University Graduate School of Medicine |
| | | Hiroyuki Kuwano, MD, PhD | |
| | Email:
hkuwano@med.gunma-u.ac.jp |
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Otashi |
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| | | Gunma Cancer Center |
| | | Shinichi Sameshima, MD, PhD | |
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| Hiroshima |
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Fukuyama |
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| | | | Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers |
| | | Takeshi Kanbara, MD | |
| | | National Hospital Organization Fukuyama Medical Center |
| | | Hiromi Iwagaki | |
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Hiroshima |
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| | | Hiroshima University Hospital |
| | | Contact Person | |
| | Email:
mokajima@hiroshima-u.ac.jp |
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Kure |
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| | | National Hospital Organization Kure Medical Center |
| | | Masato Koseki, MD | |
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Miyoshi |
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| | | Miyoshi Central Hospital |
| | | Naokuni Tatsumoto, MD, PhD | |
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| Hokkaido |
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Asahikawa |
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| | | | Asahikawa Medical College |
| | | Toru Kono, MD | |
| | | Otaru Ekisaikai Hospital |
| | | Kazuaki Sasaki, MD, PhD | |
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Hakodate |
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| | | Hakodate Goryoukaku Hospital |
| | | Akinori Takagane, MD | |
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Otaru-shi |
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| | | Hirosaki University, School of Medicine |
| | | Akihiko Murata, MD | |
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Sapporo |
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| | | Hokkaido University Graduate School of Medicine |
| | | Satoshi Kondo, MD | |
| | | Sapporo City General Hospital |
| | | Tatsuyoshi Fukushima, MD | |
| | | Sapporo Medical University |
| | | Tomohisa Furuhata, MD | |
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| Hyogo |
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Akashi |
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| | | | Hyogo Cancer Center |
| | | Takeshi Nakamura, MD | |
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Akou |
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| | | Ako City Hospital |
| | | Tadashi Yokoyama, MD | |
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Amagasaki |
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| | | Hyogo Prefectural Amagasaki Hospital |
| | | Hisashi Shinohara, MD | |
| | | Kansai Rosai Hospital |
| | | Syu Okamura | |
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Himeji |
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| | | Himeji Central Hospital |
| | | Yoshinori Munemoto, MD | |
| | | Himeji St. Mary's Hospital |
| | | Contact Person | |
| | Email:
yokoyama@himemaria.or.jp |
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Kakogawa |
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| | | Kakogawa Municipal Hospital |
| | | Masaaki Mitsutsuji, MD, PhD | |
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Kobe |
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| | | Kobe Medical Center |
| | | Etsuji Shimada, MD | |
| | | Kobe University Hospital |
| | | Takashi Kamigaki, MD | |
| | | Kobe West City Hospital |
| | | Masahiko Takeo | |
| | | Nishi-Kobe Medical Center |
| | | Husao Ikeda, MD | |
| | | Sano Hospital |
| | | Masahito Kotaka, MD | |
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Kobe-shi |
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| | | Kobe City General Hospital |
| | | Noriyuki Okada, MD, PhD | |
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Nishinomiya |
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| | | Hyogo College of Medicine |
| | | Contact Person | |
| | Email:
ntomita@hyo-med.ac.jp |
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Sumoto |
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| | | Hyogo Prefectural Awaji Hospital |
| | | Masahiko Umeki, MD, PhD | |
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Takarazuka |
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| | | Takarazuka Municipal Hospital |
| | | Chang Wooho, MD | |
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Takarazukai |
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| | | Higashi Takarazuka Satoh Hospital |
| | | Atsushi Ohkawa, MD | |
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| Ibaraki |
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Ibaraki |
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| | | | National Hospital Organization Mito Medical Center |
| | | Contact Person | |
| | Email:
koizumim@mito.hosp.go.jp |
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| Kagawa |
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Miki |
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| | | | Kagawa University Hospital |
| | | Keiichi Okano, MD | |
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Takamatsu |
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| | | Kagawa Prefectural Central Hospital |
| | | Ichio Suzuka, MD | |
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| Kagoshima |
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Kagoshima |
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| | | | Nanpuh Hospital |
| | | Toyokuni Suenaga, MD | |
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| Kanagawa |
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Ashigarakami-gun |
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| | | | Kanagawa Prefectural Ashigawa-kami Hospital |
| | | Yuji Yamamoto, MD, PhD | |
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Chigasaki, 253-0083 |
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| | | Chigasaki Municipal Hospital |
| | | Contact Person | |
| | Email:
hosp_keiei@city.chigasaki.kanagawa.jp |
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Kanagawa |
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| | | Kitasato University School of Medicine |
| | | Masahiko Watanabe, MD, PhD | |
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Kawasaki |
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| | | Kanto Rosai Hospital |
| | | Masahiro Ishimaru, MD | | Ph: | 81-44-411-3131 ext. 8101 | | |
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Yokohama |
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| | | International Goodwill Hospital |
| | | Noriaki Kameyama, MD, PhD | |
| | | Kanagawa Cancer Center |
| | | Makoto Akaike, MD | |
| | | Yokohama City Hospital |
| | | Daiduke Minabe, MD | |
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| Kochi |
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Nankoku |
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| | | | Kochi Medical School |
| | | Michiya Kobayashi, MD, PhD | |
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| Kumamoto |
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Kumamoto |
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| | | | Japanese Red Cross Kumamoto Hospital |
| | | Toshihiko Hirata, MD | |
| | | | Kumamoto University Faculty of Medical and Pharmaceutical Sciences |
| | | Naoko Hayashi, MD | |
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Uki |
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| | | National Hospital Organization - Kumamotominami Hospital |
| | | Junji Akagi, MD, PhD | |
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Yatsushiro |
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| | | Yatsushiro Health Insurance General Hospital |
| | | Masafumi Kuramoto, MD | |
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| Kyoto |
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Kanigyou-ku |
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| | | | Kyoto Second Red Cross Hospital |
| | | Hitoshi Izumi, MD | |
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Kyoto |
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| | | Kyoto Prefectural University of Medicine |
| | | Chohei Sakakura, MD, PhD | |
| | | Nishijin Hospital |
| | | Takuya Miyagaki, MD, PhD | |
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| Mie |
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Thu-shi |
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| | | | Mie University Graduate School of Medicine |
| | | Yashuhiro Inoue, MD, PhD | | Ph: | 81-59-232-1111 ext. 5645 | | |
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| Miyagi |
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Natori-shi |
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| | | | Miyagi Cancer Center |
| | | Kenichi Shiiba, MD | |
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Sendai |
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| | | Tohoku Rosai Hospital |
| | | Hiroaki Musha, MD | |
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| Nagano |
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Iida |
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| | | | Iida Municipal Hospital |
| | | Noriyuki Akita, MD | |
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Komagane |
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| | | Showa-Inan General Hospital |
| | | Ken Hayashi, MD | |
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Matsumoto |
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| | | Aizawa Hospital |
| | | Katsunori Tauchi, MD, PhD | |
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Nagano |
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| | | Nagano Red Cross Hospital |
| | | Contact Person | |
| | Email:
h.sodeyama@nagano-med.jrc.or.jp |
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Nagano-shi |
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| | | Nagano Municipal Hospital |
| | | Yasuhiro Munakata, MD | |
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Nakano |
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| | | Hokushin Hospital |
| | | Kiyofumi Yamagishi, MD | |
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| Nagasaki |
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Nagasaki |
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| | | | Nagasaki University Hospital of Medicine and Dentistry |
| | | Terumitsu Sawai, MD | |
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| Nara |
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Nara |
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| | | | Saiseikai Nara Hospital |
| | | Michiyoshi Hisanaga, MD, PhD | |
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Yamatotakada |
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| | | Kenseikai Nara Coloproctology Center |
| | | Contact Person | |
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| Niigata |
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Niigata |
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| | | | Saiseikai Niigata Daini Hospital |
| | | Yasuo Sakai, MD | |
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Niigata-shi |
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| | | Niigata Cancer Center Hospital |
| | | Yasumasa Takii, MD | |
| | | Niigata University Medical and Dental Hospital |
| | | Tsuneo Iiai, MD | |
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| Oita |
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Yufu-shi |
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| | | | Oita University Hospital |
| | | Seigo Kitano, MD, PhD | |
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| Okayama |
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Kurashiki |
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| | | | Kurashiki Central Hospital |
| | | Tadashi Itoh, MD, PhD | |
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Okayama |
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| | | Okayama University Medical School |
| | | Nagahide Matsubara, MD | |
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| Osaka |
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Hirakata |
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| | | | Hoshigaoka Koseinenkin Hospital |
| | | Mitsutoshi Tatsumi, MD, PhD | |
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Izumisano |
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| | | Rinku General Medical Center |
| | | Masaaki Izukura | |
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Mino |
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| | | Minoh City Hospital |
| | | Takeshi Kato, MD, PhD | |
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Osaka |
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| | | Higashi Sumiyoshi Morimoto Hospital |
| | | Hiromu Tanaka, MD | |
| | | Kitano Hospital |
| | | Arimichi Takabayashi | |
| | Email:
atakaba@kitano-hp.or.jp |
| | | Minamiosaka Hospital |
| | | Toshio Ihara, MD | |
| | | Nissay Hospital |
| | | Yukou Hamanaka, MD | |
| | | Osaka City Juso Hospital |
| | | Yosuke Fukunaga, MD | |
| | | Osaka Saiseikai Noe Hospital |
| | | Contact Person | |
| | Email:
mdad@alles.or.jp |
| | | Otemae Hospital |
| | | Hiroshi Noro, MD | |
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Osaka-shi |
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| | | Osaka City General Hospital |
| | | Masayuki Higashino, MD | |
| | | Osaka General Medical Center |
| | | Yasuhiro Tanaka, MD | |
| | | Osaka Kosei Nenkin Hospital |
| | | Akira Ito, MD | |
| | | Osaka Police Hospital |
| | | Masaaki Nakahara, MD | |
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Sakai-shi |
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| | | Osaka Rosai Hospital |
| | | Junichi Hasegawa, MD | |
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Suita-shi |
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| | | Suita Municipal Hospital |
| | | Kohei Murata, MD, PhD | |
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Takatsuki |
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| | | Osaka Medical College |
| | | Junji Okuda, MD, PhD | |
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Tondabayashi |
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| | | Saiseikai Tondabayashi Hospital |
| | | Akira Maeda | |
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| Saitama |
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Fukaya |
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| | | | Fukaya Red Cross Hospital |
| | | Hiroshi Ishikawa, MD, PhD | |
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Hasuda |
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| | | Hasuda Hospital |
| | | Contact Person | |
| | Email:
s-hamada@hasuda-hp.or.jp |
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Kawagoe-shi |
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| | | Saitama Medical School Hospital |
| | | Hideyuki Ishida, MD | |
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Saitama |
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| | | Saitama Social Insurance Hospital |
| | | Kohsei Hisa, MD | |
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Tokorozawa |
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| | | National Defense Medical College |
| | | Hideki Ueno, MD, PhD | |
| | Email:
ueno@ndmc.ac.jp |
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| Shiga |
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Nagahama |
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| | | | Nagahama City Hospital |
| | | Contact Person | |
| | Email:
kanda-yuji@nagahama-hp.jp |
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Otsu |
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| | | Otsu Municipal Hospital |
| | | Ken Yanagibashi, MD, PhD | |
| | Email:
kenyanagibashi@msn.com |
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| Shimane |
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Izumo-shi |
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| | | | Shimane Prefectural Central Hospital |
| | | Nobuhiro Ozaki | |
| | Email:
osaki@spch.izumo.shimane.jp |
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| Shizuoka |
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Fujieda |
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| | | | Fujieda Municipal General Hospital |
| | | Kennoki Kyo, MD, PhD | |
| | Email:
kkyo@vega.ocn.ne.jp |
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Hamamatsu-shi |
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| | | Hamamatsu University School of Medicine |
| | | Toshio Nakamura, MD | |
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Shizuoka |
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| | | Shizuoka City Hospital |
| | | Kei Yonezawa, MD, PhD | |
| | | Shizuoka Municipal Shimizu Hospital |
| | | Iwao Matsuda, MD | |
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Yaizu |
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| | | Yaizu Municipal Hospital |
| | | Takeyuki Hiramatsu, MD, PhD | |
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| Tochigi |
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Shimotsuke-shi |
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| | | | Jichi Medical School |
| | | Hisanaga Horie, MD, PhD | |
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Utsunomiya |
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| | | Tochigi Cancer Center |
| | | Takashi Matsui, MD | |
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| Tokushima |
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Anan |
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| | | | Anan Kyoei Hospital |
| | | Contact Person | |
| | Email:
mich-undo@shirt.ocn.ne.jp |
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| Tokyo |
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Chuo-ku |
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| | | | St. Luke's International Hospital |
| | | Hisashi Onodera, MD, PhD | |
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Fuchu |
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| | | Tokyo Metropolitan Fuchu Hospital |
| | | Jun Matsumoto, MD | |
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Kodaira |
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| | | Shouwa General Hospital |
| | | Contact Person | |
| | Email:
miki-kenji@umin.ac.jp |
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Komae |
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| | | Daisan Hospital |
| | | Katsuhito Suwa, MD | |
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Mitaka |
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| | | Kyorin University School of Medicine - Mitaka Campus |
| | | Tadahiko Masaki, MD, PhD | |
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Shinjuku-ku |
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| | | Social Insurance Chuo General Hospital |
| | | Rikisaburoh Sahara, MD, PhD | |
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Shinjyuku-ku |
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| | | Tokyo Women's Medical University |
| | | Shingo Kameoka, MD, PhD | |
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Tokyo |
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| | | International Medical Center of Japan |
| | | Yukio Saito, MD, PhD | |
| | | Itabashi Chuo Medical Center |
| | | Contact Person | |
| | Email:
hmtym218md@kmd.biglobe.ne.jp |
| | | Japanese Red Cross Medical Center |
| | | Takeshi Endo, MD | |
| | | Mita Hospital at the International University of Health and Welfare |
| | | Ken-ichi Mafune, MD | |
| | Email:
mafune@iuhw.ac.jp |
| | | Nippon Medical School |
| | | Kiyonori Furukawa | |
| | | Takasago Kyoritsu Hospital |
| | | Contact Person | |
| | Email:
shoji-md@fc4.so-net.ne.jp |
| | | Teikyo University School of Medicine |
| | | Toshiaki Watanabe, MD, PhD | |
| | | Toho University School of Medicine |
| | | Tatsuo Teramoto, MD | | Ph: | 81-3-3762-4151 ext. 3553 | | |
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| | Email:
tteramot@med.toho-u.ac.jp |
| | | Tokyo Medical and Dental University |
| | | Hiroyuki Uetake, MD | |
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| Tottori |
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Yonago |
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| | | | Tottori University - Faculty of Medicine |
| | | Kuniyuki Katano, MD, PhD | |
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| Toyama |
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Takaoka-shi |
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| | | | Koseiren Takaoka Hospital |
| | | Nozawal Hiroshi, MD | |
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| Wakayama |
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Tanabe |
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| | | | Social Insurance Kinan Hospital |
| | | Makio Nagaoka, MD | |
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| Yamagata |
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Yamagata |
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| | | | Yamagata Prefectural Central Hospital |
| | | Contact Person | |
| | Email:
toshi.st@ypch.gr.jp |
| | | Yamagata University Hospital |
| | | Contact Person | |
| | Email:
wkimura@med.id.yamagata-u.ac.jp |
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| Yamaguchi |
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Shimonoseki |
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| | | | National Hospital Organization - Kanmon Medical Center |
| | | Takumi Furuya, MD | |
| | | Shimonoseki Kosei Hospital |
| | | Toshimasa Okada, MD, PhD | |
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Ube |
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| | | Yamaguchi University Graduate School of Medicine |
| | | Masaaki Oka, MD, PhD | |
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| Yamanashi |
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Chu-o-shi |
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| | | | University of Yamanashi Faculty of Medicine |
| | | Hiroshi Iino, MD, PhD | |
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| Registry Information | | | Official Title | | Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy with UFT | | | Trial Start Date | | 2006-10-01 | | | Registered in ClinicalTrials.gov | | NCT00898846 | | | Date Submitted to PDQ | | 2007-05-17 | | | Information Last Verified | | 2009-07-05 |
Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.  Back to Top |
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