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

Outcomes

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

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