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Last Modified: 2/24/2009     First Published: 5/25/2007  
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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

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysisActive20 to 75OtherTMDU-BRI-CC-05-02
BRI-CC-05-02, NCT00898846

Objectives

  1. Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.
  2. Identify predictive factors of chemosensitivity to this regimen in these patients.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed adenocarcinoma of the colon or rectosigmoid
    • Stage II disease


  • Must be registered on clinical trial TMDU-BRI-CC-05-01


  • Must have resected tumor tissue available


  • No hereditary colorectal cancer


Prior/Concurrent Therapy:

  • Not specified

Patient Characteristics:

  • ECOG performance status 0-1

Expected Enrollment

1000

Outcomes

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
Ph: 81-3-5803-5261
Email: k-sugi.srg2@tmd.ac.jp

Trial Sites

Japan
  Osaka
 Osaka Red Cross Hospital
 Akiyoshi Kanazawa, MD, PhD
Ph: 81-6-6774-5111
Aichi
  Nagoya
 Ban Buntane Houtokukai Hospital
 Satoshi Arakawa, MD
Ph: 81-52-321-8171
 Nagoya Ekisaikai Hospital
 Hiroshi Kohno, MD
Ph: 81-52-652-7711
 Nagoya Midori Municipal Hospital
 Takuji Fukui, MD, PhD
Ph: 81-52-892-1331
 Nagoya University Hospital
 Yasuhiro Kodera, MD
Ph: 81-52-744-2250
 Email: ykodera@med.nagoya-u.ac.jp
 Nagoya University School of Medicine
 Norihiko Yuasa, MD, PhD
Ph: 81-52-744-2222
  Okazaki
 Aichi Prefectural Hospital
 Contact Person
Ph: 81-564-21-6251
 Email: matsui-ngy@umin.ac.jp
Akita
  Noshiro
 Yamamoto Kumiai General Hospital
 Kenichi Oyama, MD
Ph: 81-185-52-3111
  Yokote
 Hiraka General Hospital
 Contact Person
Ph: 81-182-32-5121
 Email: fcl3btkai@yahoo.co.jp
Chiba
  Chiba
 Chiba Cancer Center
 Contact Person
Ph: 81-43-226-2110
 Email: miyahide@faculty.chiba-u.jp
  Ichihara
 Teikyo University Chiba Medical Center
 Toru Tezuka, MD, PhD
Ph: 81-436-62-1211
  Inba-gunn
 Asahi General Hospital
 Noritake Tanaka, PhD
Ph: 81-476-99-1111
Fukui
  Fukui-shi
 Fukuiken Saiseikai Hospital
 Yoshinori Munemoto, MD
Ph: 81-776-23-1111
  Yoshida-gun
 University of Fukui Hospital
 Akio Yamaguchi, MD, PhD
Ph: 86-776-61-8372
 Email: akio@u-fukui.ac.jp
Fukuoka
  Fukuoka
 National Hospital Organization Kyushu Medical Center
 Tetsuya Kusumoto, MD, PhD
  Fukuoka-shi
 Kyushu University Hospital
 Yoshihiko Maehara, MD, PhD
Ph: 81-92-642-5461
  Kitakyushu
 Kitakyushu Municipal Medical Center
 Yoshitaka Tanabe
Ph: 81-93-541-1831
  Kurume
 Kurume University School of Medicine
 Kazuo Shirouzu, MD, PhD
Ph: 81-942-31-7566
 Email: skazuo@med.kurume-u.ac.jp
 Saint Mary's Hospital
 Satoshi Taniwaki, MD
Ph: 81-942-35-3322
  Tagawa
 Social Insurance Tagawa Hospital
 Takaho Tanaka, MD, PhD
Ph: 81-947-44-0460
Fukushima
  Fukushima-shi
 Fukushima Medical University Hospital
 Shinji Ohki, MD, PhD
Ph: 81-24-547-1259
Gifu
  Gifu
 Matsunami General Hospital
 Kenji Kobayashi, MD
Ph: 81-58-388-0111
  Gifu-shi
 Gifu Municipal Hospital
 Hiroo Oshita, MD
Ph: 81-58-251-1101
  Hashima
 Hashima City Hospital
 Mikio Yasumura, MD, PhD
Ph: 81-58-393-0111
  Ogaki-shi
 Ogaki Municipal Hospital
 Masatoshi Isogai, MD, PhD
Ph: 81-584-81-3341
Gunma
  Maebashi-shi
 Gunma University Graduate School of Medicine
 Hiroyuki Kuwano, MD, PhD
Ph: 81-27-220-8224
 Email: hkuwano@med.gunma-u.ac.jp
  Otashi
 Gunma Cancer Center
 Shinichi Sameshima, MD, PhD
Ph: 81-276-38-0771
Hiroshima
  Fukuyama
 Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
 Takeshi Kanbara, MD
Ph: 81-84-970-2121
 National Hospital Organization Fukuyama Medical Center
 Hiromi Iwagaki
Ph: 81-84-922-0001
  Hiroshima
 Hiroshima University Hospital
 Contact Person
Ph: 81-82-257-5222
 Email: mokajima@hiroshima-u.ac.jp
  Kure
 National Hospital Organization Kure Medical Center
 Masato Koseki, MD
Ph: 81-823-22-3111
  Miyoshi
 Miyoshi Central Hospital
 Naokuni Tatsumoto, MD, PhD
Ph: 81-824-65-0101
Hokkaido
  Asahikawa
 Asahikawa Medical College
 Toru Kono, MD
Ph: 81-166-68-2503
 Otaru Ekisaikai Hospital
 Kazuaki Sasaki, MD, PhD
Ph: 81-134-24-0325
  Hakodate
 Hakodate Goryoukaku Hospital
 Akinori Takagane, MD
Ph: 81-138-51-2295
  Otaru-shi
 Hirosaki University, School of Medicine
 Akihiko Murata, MD
Ph: 81-172-39-5079
  Sapporo
 Hokkaido University Graduate School of Medicine
 Satoshi Kondo, MD
Ph: 81-11-706-7714
 Sapporo City General Hospital
 Tatsuyoshi Fukushima, MD
Ph: 81-11-726-2211
 Sapporo Medical University
 Tomohisa Furuhata, MD
Ph: 81-11-611-2111
Hyogo
  Akashi
 Hyogo Cancer Center
 Takeshi Nakamura, MD
Ph: 81-78-929-1151
  Akou
 Ako City Hospital
 Tadashi Yokoyama, MD
Ph: 81-791-43-3222
  Amagasaki
 Hyogo Prefectural Amagasaki Hospital
 Hisashi Shinohara, MD
Ph: 81-6-6482-1521
 Kansai Rosai Hospital
 Syu Okamura
Ph: 81-6-6416-1221
  Himeji
 Himeji Central Hospital
 Yoshinori Munemoto, MD
Ph: 81-79-235-7331
 Himeji St. Mary's Hospital
 Contact Person
Ph: 81-79-265-5111
 Email: yokoyama@himemaria.or.jp
  Kakogawa
 Kakogawa Municipal Hospital
 Masaaki Mitsutsuji, MD, PhD
Ph: 81-794-32-3531
  Kobe
 Kobe Medical Center
 Etsuji Shimada, MD
Ph: 81-78-791-0111
 Kobe University Hospital
 Takashi Kamigaki, MD
Ph: 81-78-382-5111
 Kobe West City Hospital
 Masahiko Takeo
Ph: 81-78-576-5251
 Nishi-Kobe Medical Center
 Husao Ikeda, MD
Ph: 81-78-997-2200
 Sano Hospital
 Masahito Kotaka, MD
Ph: 81-78-785-1000
  Kobe-shi
 Kobe City General Hospital
 Noriyuki Okada, MD, PhD
Ph: 81-78-302-4321
  Nishinomiya
 Hyogo College of Medicine
 Contact Person
Ph: 81-798-45-6372
 Email: ntomita@hyo-med.ac.jp
  Sumoto
 Hyogo Prefectural Awaji Hospital
 Masahiko Umeki, MD, PhD
Ph: 81-799-22-1200
  Takarazuka
 Takarazuka Municipal Hospital
 Chang Wooho, MD
Ph: 81-797-87-1161
  Takarazukai
 Higashi Takarazuka Satoh Hospital
 Atsushi Ohkawa, MD
Ph: 81-797-88-2200
Ibaraki
  Ibaraki
 National Hospital Organization Mito Medical Center
 Contact Person
Ph: 81-29-240-7711
 Email: koizumim@mito.hosp.go.jp
Kagawa
  Miki
 Kagawa University Hospital
 Keiichi Okano, MD
Ph: 81-87-891-2438
  Takamatsu
 Kagawa Prefectural Central Hospital
 Ichio Suzuka, MD
Ph: 81-87-835-2222
Kagoshima
  Kagoshima
 Nanpuh Hospital
 Toyokuni Suenaga, MD
Ph: 81-99-226-9111
Kanagawa
  Ashigarakami-gun
 Kanagawa Prefectural Ashigawa-kami Hospital
 Yuji Yamamoto, MD, PhD
Ph: 81-465-83-0351
  Chigasaki, 253-0083
 Chigasaki Municipal Hospital
 Contact Person
Ph: 81-467-52-1111
 Email: hosp_keiei@city.chigasaki.kanagawa.jp
  Kanagawa
 Kitasato University School of Medicine
 Masahiko Watanabe, MD, PhD
Ph: 81-42-778-8735
  Kawasaki
 Kanto Rosai Hospital
 Masahiro Ishimaru, MD
Ph: 81-44-411-3131 ext. 8101
  Yokohama
 International Goodwill Hospital
 Noriaki Kameyama, MD, PhD
Ph: 81-45-813-0221
 Kanagawa Cancer Center
 Makoto Akaike, MD
Ph: 81-45-391-5761
 Yokohama City Hospital
 Daiduke Minabe, MD
Ph: 81-45-331-1961
Kochi
  Nankoku
 Kochi Medical School
 Michiya Kobayashi, MD, PhD
Ph: 81-88-880-2202
Kumamoto
  Kumamoto
 Japanese Red Cross Kumamoto Hospital
 Toshihiko Hirata, MD
Ph: 81-96-384-2111
 Kumamoto University Faculty of Medical and Pharmaceutical Sciences
 Naoko Hayashi, MD
Ph: 81-96-373-5212
  Uki
 National Hospital Organization - Kumamotominami Hospital
 Junji Akagi, MD, PhD
Ph: 81-964-32-0826
  Yatsushiro
 Yatsushiro Health Insurance General Hospital
 Masafumi Kuramoto, MD
Ph: 81-965-32-71111
Kyoto
  Kanigyou-ku
 Kyoto Second Red Cross Hospital
 Hitoshi Izumi, MD
Ph: 81-75-231-5171
  Kyoto
 Kyoto Prefectural University of Medicine
 Chohei Sakakura, MD, PhD
Ph: 81-75-251-5527
 Nishijin Hospital
 Takuya Miyagaki, MD, PhD
Ph: 81-75-461-8800
Mie
  Thu-shi
 Mie University Graduate School of Medicine
 Yashuhiro Inoue, MD, PhD
Ph: 81-59-232-1111 ext. 5645
Miyagi
  Natori-shi
 Miyagi Cancer Center
 Kenichi Shiiba, MD
Ph: 81-22-381-3151
  Sendai
 Tohoku Rosai Hospital
 Hiroaki Musha, MD
Ph: 81-22-275-1111
Nagano
  Iida
 Iida Municipal Hospital
 Noriyuki Akita, MD
Ph: 81-265-21-1255
  Komagane
 Showa-Inan General Hospital
 Ken Hayashi, MD
Ph: 81-265-52-5800
  Matsumoto
 Aizawa Hospital
 Katsunori Tauchi, MD, PhD
Ph: 81-263-33-8600
  Nagano
 Nagano Red Cross Hospital
 Contact Person
Ph: 81-26-226-4131
 Email: h.sodeyama@nagano-med.jrc.or.jp
  Nagano-shi
 Nagano Municipal Hospital
 Yasuhiro Munakata, MD
Ph: 81-26-295-1199
  Nakano
 Hokushin Hospital
 Kiyofumi Yamagishi, MD
Ph: 81-269-22-2151
Nagasaki
  Nagasaki
 Nagasaki University Hospital of Medicine and Dentistry
 Terumitsu Sawai, MD
Ph: 81-95-849-7304
Nara
  Nara
 Saiseikai Nara Hospital
 Michiyoshi Hisanaga, MD, PhD
Ph: 81-742-36-1881
  Yamatotakada
 Kenseikai Nara Coloproctology Center
 Contact Person
Ph: 81-745-53-5471
Niigata
  Niigata
 Saiseikai Niigata Daini Hospital
 Yasuo Sakai, MD
Ph: 81-25-233-6161
  Niigata-shi
 Niigata Cancer Center Hospital
 Yasumasa Takii, MD
Ph: 81-25-266-5111
 Niigata University Medical and Dental Hospital
 Tsuneo Iiai, MD
Ph: 81-25-227-2228
Oita
  Yufu-shi
 Oita University Hospital
 Seigo Kitano, MD, PhD
Ph: 81-97-586-5840
Okayama
  Kurashiki
 Kurashiki Central Hospital
 Tadashi Itoh, MD, PhD
Ph: 81-86-422-0210
  Okayama
 Okayama University Medical School
 Nagahide Matsubara, MD
Ph: 81-86-235-7257
Osaka
  Hirakata
 Hoshigaoka Koseinenkin Hospital
 Mitsutoshi Tatsumi, MD, PhD
Ph: 81-72-840-2641
  Izumisano
 Rinku General Medical Center
 Masaaki Izukura
Ph: 81-724-69-3111
  Mino
 Minoh City Hospital
 Takeshi Kato, MD, PhD
Ph: 81-72-728-2001
  Osaka
 Higashi Sumiyoshi Morimoto Hospital
 Hiromu Tanaka, MD
Ph: 81-6-6606-0010
 Kitano Hospital
 Arimichi Takabayashi
Ph: 81-6-6312-1221
 Email: atakaba@kitano-hp.or.jp
 Minamiosaka Hospital
 Toshio Ihara, MD
Ph: 81-6-6685-0221
 Nissay Hospital
 Yukou Hamanaka, MD
Ph: 81-6-6543-3581
 Osaka City Juso Hospital
 Yosuke Fukunaga, MD
Ph: 81-6-6150-8000
 Osaka Saiseikai Noe Hospital
 Contact Person
Ph: 81-6-6932-0401
 Email: mdad@alles.or.jp
 Otemae Hospital
 Hiroshi Noro, MD
Ph: 81-6-6941-0484
  Osaka-shi
 Osaka City General Hospital
 Masayuki Higashino, MD
Ph: 81-6-6929-1221
 Osaka General Medical Center
 Yasuhiro Tanaka, MD
Ph: 81-6-6692-1201
 Osaka Kosei Nenkin Hospital
 Akira Ito, MD
Ph: 81-6-6441-5451
 Osaka Police Hospital
 Masaaki Nakahara, MD
Ph: 81-6-6771-6051
  Sakai-shi
 Osaka Rosai Hospital
 Junichi Hasegawa, MD
Ph: 81-72-252-3561
  Suita-shi
 Suita Municipal Hospital
 Kohei Murata, MD, PhD
Ph: 81-6-6387-3311
  Takatsuki
 Osaka Medical College
 Junji Okuda, MD, PhD
Ph: 81-72-683-1221
  Tondabayashi
 Saiseikai Tondabayashi Hospital
 Akira Maeda
Ph: 81-721-29-1121
Saitama
  Fukaya
 Fukaya Red Cross Hospital
 Hiroshi Ishikawa, MD, PhD
Ph: 81-48-571-1511
  Hasuda
 Hasuda Hospital
 Contact Person
Ph: 81-48-766-8111
 Email: s-hamada@hasuda-hp.or.jp
  Kawagoe-shi
 Saitama Medical School Hospital
 Hideyuki Ishida, MD
Ph: 81-49-228-3700
  Saitama
 Saitama Social Insurance Hospital
 Kohsei Hisa, MD
Ph: 81-48-832-4951
  Tokorozawa
 National Defense Medical College
 Hideki Ueno, MD, PhD
Ph: 81-42-995-1637
 Email: ueno@ndmc.ac.jp
Shiga
  Nagahama
 Nagahama City Hospital
 Contact Person
Ph: 81-749-68-2300
 Email: kanda-yuji@nagahama-hp.jp
  Otsu
 Otsu Municipal Hospital
 Ken Yanagibashi, MD, PhD
Ph: 81-77-522-4607
 Email: kenyanagibashi@msn.com
Shimane
  Izumo-shi
 Shimane Prefectural Central Hospital
 Nobuhiro Ozaki
Ph: 81-853-22-5111
 Email: osaki@spch.izumo.shimane.jp
Shizuoka
  Fujieda
 Fujieda Municipal General Hospital
 Kennoki Kyo, MD, PhD
Ph: 81-54-646-1111
 Email: kkyo@vega.ocn.ne.jp
  Hamamatsu-shi
 Hamamatsu University School of Medicine
 Toshio Nakamura, MD
Ph: 81-53-435-2279
  Shizuoka
 Shizuoka City Hospital
 Kei Yonezawa, MD, PhD
Ph: 81-54-253-3125
 Shizuoka Municipal Shimizu Hospital
 Iwao Matsuda, MD
Ph: 81-54-336-1111
  Yaizu
 Yaizu Municipal Hospital
 Takeyuki Hiramatsu, MD, PhD
Ph: 81-54-623-3111
Tochigi
  Shimotsuke-shi
 Jichi Medical School
 Hisanaga Horie, MD, PhD
Ph: 81-285-58-7371
  Utsunomiya
 Tochigi Cancer Center
 Takashi Matsui, MD
Ph: 81-28-658-5151
Tokushima
  Anan
 Anan Kyoei Hospital
 Contact Person
Ph: 81-884-44-3131
 Email: mich-undo@shirt.ocn.ne.jp
Tokyo
  Chuo-ku
 St. Luke's International Hospital
 Hisashi Onodera, MD, PhD
Ph: 81-3-3541-5151
  Fuchu
 Tokyo Metropolitan Fuchu Hospital
 Jun Matsumoto, MD
Ph: 81-42-323-5111
  Kodaira
 Shouwa General Hospital
 Contact Person
Ph: 81-42-461-0052
 Email: miki-kenji@umin.ac.jp
  Komae
 Daisan Hospital
 Katsuhito Suwa, MD
Ph: 81-3-3480-1151
  Mitaka
 Kyorin University School of Medicine - Mitaka Campus
 Tadahiko Masaki, MD, PhD
Ph: 81-422-47-5511
  Shinjuku-ku
 Social Insurance Chuo General Hospital
 Rikisaburoh Sahara, MD, PhD
Ph: 81-3-3364-0251
  Shinjyuku-ku
 Tokyo Women's Medical University
 Shingo Kameoka, MD, PhD
Ph: 81-3-3353-8111
  Tokyo
 International Medical Center of Japan
 Yukio Saito, MD, PhD
Ph: 81-3-3202-7181
 Itabashi Chuo Medical Center
 Contact Person
Ph: 81-3-3967-1181
 Email: hmtym218md@kmd.biglobe.ne.jp
 Japanese Red Cross Medical Center
 Takeshi Endo, MD
Ph: 81-3-3400-1311
 Mita Hospital at the International University of Health and Welfare
 Ken-ichi Mafune, MD
Ph: 81-3-3451-8121
 Email: mafune@iuhw.ac.jp
 Nippon Medical School
 Kiyonori Furukawa
Ph: 81-3-3822-2131
 Takasago Kyoritsu Hospital
 Contact Person
Ph: 81-3-3672-1046
 Email: shoji-md@fc4.so-net.ne.jp
 Teikyo University School of Medicine
 Toshiaki Watanabe, MD, PhD
Ph: 81-3-3964-1231
 Toho University School of Medicine
 Tatsuo Teramoto, MD
Ph: 81-3-3762-4151 ext. 3553
 Email: tteramot@med.toho-u.ac.jp
 Tokyo Medical and Dental University
 Hiroyuki Uetake, MD
Ph: 81-3-5803-5261
Tottori
  Yonago
 Tottori University - Faculty of Medicine
 Kuniyuki Katano, MD, PhD
Ph: 81-859-38-6567
Toyama
  Takaoka-shi
 Koseiren Takaoka Hospital
 Nozawal Hiroshi, MD
Ph: 81-766-21-3930
Wakayama
  Tanabe
 Social Insurance Kinan Hospital
 Makio Nagaoka, MD
Ph: 81-739-22-5000
Yamagata
  Yamagata
 Yamagata Prefectural Central Hospital
 Contact Person
Ph: 81-23-685-2626
 Email: toshi.st@ypch.gr.jp
 Yamagata University Hospital
 Contact Person
Ph: 81-23-628-5336
 Email: wkimura@med.id.yamagata-u.ac.jp
Yamaguchi
  Shimonoseki
 National Hospital Organization - Kanmon Medical Center
 Takumi Furuya, MD
Ph: 81-832-22-6216
 Shimonoseki Kosei Hospital
 Toshimasa Okada, MD, PhD
Ph: 81-832-31-5811
  Ube
 Yamaguchi University Graduate School of Medicine
 Masaaki Oka, MD, PhD
Ph: 81-836-22-2262
Yamanashi
  Chu-o-shi
 University of Yamanashi Faculty of Medicine
 Hiroshi Iino, MD, PhD
Ph: 81-55-273-7390

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.

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