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Last Modified: 7/19/2007     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

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
Sponsor
Protocol IDs

No phase specified


Biomarker/Laboratory analysis


Active


20 to 75


Other


TMDU-BRI-CC-05-02
BRI-CC-05-02

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

Trial Sites

Japan
Aichi
  Nagoya
 Nagoya Ekisaikai Hospital
 Hiroshi Kohno, MD
Ph: 81-52-652-7711
 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
Chiba
  Inba-gunn
 Asahi General Hospital
 Noritake Tanaka, PhD
Ph: 81-476-99-1111
 Nippon Medical School
 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-shi
 Kyushu University Hospital
 Yoshihiko Maehara, MD, PhD
Ph: 81-92-642-5461
  Kitakyushu-shi
 Kitakyushu Municipal Medical Center
 Hiroyuki Konomi, MD, PhD
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-shi
 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-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
 National Hospital Organization Fukuyama Medical Center
 Sadanori Fuchimoto, MD, PhD
Ph: 81-84-922-0001
  Kure
 National Hospital Organization Kure Medical Center
 Masato Koseki, MD
Ph: 81-823-22-3111
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 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
 Naohiro Tomita, MD, PhD
Ph: 81-79-845-6370
  Himeji
 Himeji Central Hospital
 Yoshinori Munemoto, MD
Ph: 81-79-235-7331
  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
 Mitsuo Yamamoto, MD
Ph: 81-78-576-5251
 Email: mitsuo-yamamoto@kobe-nishishimin-hospi.jp
  Kobe-shi
 Kobe City General Hospital
 Noriyuki Okada, MD, PhD
Ph: 81-78-302-4321
  Takarazukai
 Higashi Takarazuka Satoh Hospital
 Atsushi Ohkawa, MD
Ph: 81-797-88-2200
Kagawa
  Takamatsu
 Kagawa Prefectural Central Hospital
 Ichio Suzuka, MD
Ph: 81-87-835-2222
Kanagawa
  Ashigarakami-gun
 Kanagawa Prefectural Ashigawa-kami Hospital
 Yuji Yamamoto, MD, PhD
Ph: 81-465-83-0351
  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
 Kanagawa Cancer Center
 Makoto Akaike, MD
Ph: 81-45-391-5761
Kochi
  Nankoku
 Kochi Medical School
 Michiya Kobayashi, MD, PhD
Ph: 81-88-880-2202
Kyoto
  Kanigyou-ku
 Kyoto Second Red Cross Hospital
 Hitoshi Izumi, MD
Ph: 81-75-231-5171
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-shi
 Tohoku Rosai Hospital
 Hiroaki Musha, MD
Ph: 81-22-275-1111
Nagano
  Komagane-shi
 Showa-Inan General Hospital
 Ken Hayashi, MD
Ph: 81-265-52-5800
  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
Niigata
  Niigata-shi
 Niigata Cancer Center Hospital
 Yasumasa Takii, MD
Ph: 81-25-266-5111
 Niigata University
 Tsuneo Iiai, MD
Ph: 81-25-227-2228
 Saiseikai Niigata Daini Hospital
 Yasuo Sakai, MD
Ph: 81-25-233-6161
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
Osaka
  Izumisano-shi
 Rinku General Medical Center
 Kazuhiro Iwase, MD(Contact information may not be current)
Ph: 81-72-469-3111
  Mino
 Minoh City Hospital
 Takeshi Kato, MD, PhD
Ph: 81-72-728-2001
  Osaka
 Kitano Hospital
 Arimichi Takabayashi
Ph: 81-6-6312-1221
 Email: atakaba@kitano-hp.or.jp
 Nissay Hospital
 Yukou Hamanaka, MD
Ph: 81-6-6543-3581
  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
  Tondabayashi
 Saiseikai Tondabayashi Hospital
 Tsutomu Dousei, MD
Ph: 81-721-29-1121
Saitama
  Fukaya
 Fukaya Red Cross Hospital
 Hiroshi Ishikawa, MD, PhD
Ph: 81-48-571-1511
  Kawagoe-shi
 Saitama Medical School Hospital
 Hideyuki Ishida, MD
Ph: 81-49-228-3700
  Saitama-shi
 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
  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-shi
 Shizuoka Municipal Shimizu Hospital
 Iwao Matsuda, MD
Ph: 81-54-336-1111
  Yaizu-shi
 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-shi
 Tochigi Cancer Center
 Takashi Matsui, MD
Ph: 81-28-658-5151
Tokyo
  Chuo-ku
 St. Luke's International Hospital
 Hisashi Onodera, MD, PhD
Ph: 81-3-3541-5151
  Fuchu-shi
 Tokyo Metropolitan Fuchu Hospital
 Jun Matsumoto, MD
Ph: 81-42-323-5111
  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
 Mita Hospital at the International University of Health and Welfare
 Ken-ichi Mafune, MD
Ph: 81-3-3451-8121
 Email: mafune@iuhw.ac.jp
 Toho University School of Medicine
 Tatsuo Teramoto, MD
Ph: 81-3-3762-4151 ext. 3553