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Last Modified: 3/14/2009     First Published: 10/21/2006  
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Phase III Randomized Study of Adjuvant Tegafur-Uracil Versus Observation Only in Patients With Curatively Resected Stage II Colorectal Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive20 to 80OtherTMDU-BRI-CC-05-01
NCT00392899

Objectives

Primary

  1. Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.

Secondary

  1. Compare relapse-free and overall survival of patients treated with these regimens.
  2. Compare the occurrence of adverse events in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

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


  • Has undergone curative (R0) resection within the past 8 weeks


  • No suspicion of hereditary colorectal cancer


  • No severe postoperative complications


Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No prior chemotherapy
  • No prior or concurrent radiotherapy
  • No concurrent prophylactic growth factors
  • No concurrent biologic response modifiers

Patient Characteristics:

  • ECOG performance status 0-1
  • WBC 3,500-12,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 100 IU/L
  • Creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Able to take oral medications
  • Major organ functions are preserved
  • No other active malignancy
  • None of the following conditions:
    • Uncontrolled diabetes mellitus
    • Uncontrolled hypertension
    • Myocardial infarction or unstable angina pectoris within the past 6 months
    • Liver cirrhosis
    • Interstitial pneumonia
    • Pulmonary fibrosis
    • Severe emphysema
  • No psychiatric disease or other condition that would preclude study participation

Expected Enrollment

2000

A total of 2,000 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Disease-free survival

Secondary Outcome(s)

Relapse-free survival
Overall survival
Adverse events

Outline

This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo observation.


  • Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity.


After completion of study treatment, patients are followed periodically for 5 years.

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
  Aichi-gun
 Aichi Medical University
 Toshiaki Nonami, MD
Ph: 81-561-62-3311
  Nagoya
 Aichi Cancer Center
 Takashi Hirai, MD
Ph: 81-52-762-6111
 Email: thirai@aichi-cc.jp
 Ban Buntane Houtokukai Hospital
 Satoshi Arakawa, MD
Ph: 81-52-321-8171
 Nagoya Central Hospital
 Contact Person
Ph: 81-52-452-3165
 Email: soichiro.inoue@jr-central.co.jp
 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
 West Medical Center Jouhoku Municipal Hospital
 Takuya Ando, MD, PhD
Ph: 81-52-991-8121
  Nagoya-shi
 Japanese Red Cross Nagoya First Hospital
 Eiji Takeuchi, MD
Ph: 81-52-481-5111
 Nagoya City University Hospital
 Hiromitsu Takeyama, MD
Ph: 81-52-853-8224
  Okazaki
 Aichi Cancer Center at Aichi Hospital
 Contact Person
Ph: 81-564-21-6251
 Email: matsui-ngy@umin.ac.jp
  Toyohashi
 National Hospital Organization Toyohashi Medical Center
 Tooru Ichihara, MD, PhD
Ph: 81-532-62-0301
 Toyohashi Municipal Hospital
 Contact Person
Ph: 81-532-33-6111
 Email: hiramatsu-kazuhiro@toyohashi-mh.jp
  Toyota
 Koseiren Kamo Hospital
 Junichi Kamiya, MD, PhD
Ph: 81-565-31-1511
Akita
  Akita
 Akita Kumiai General Hospital
 Kazuhiko Endo, MD
Ph: 81-18-880-3000
  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
Aomori
  Aomori
 Aomori City Hospital
 Contact Person
Ph: 81-17-734-2171
 Email: htume@actv.ne.jp
Chiba
  Asahi-machi
 Asahi General Hospital
 Nobutaka Tanaka, MD, PhD
Ph: 81-479-63-8111
  Chiba
 Chiba Cancer Center
 Contact Person
Ph: 81-43-264-5431
 Email: ntaki@chiba-cc.jp
 Chiba University
 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
  Urayasu-shi
 Juntendo Urayasu Hospital
 Masaki Fukunaga, MD, PhD
Ph: 81-47-353-3111
 Email: masaki-f@juntendo-urayasui.jp
Ehime
  Matsuyama
 Shikoku Cancer Center
 Contact Person
Ph: 81-89-932-1111
 Email: ykubo@shikoku-cc.go.jp
  Niihama
 Sumitomo Besshi Hospital
 Hideyuki Saeki, MD
Ph: 81-397-37-7111
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
 National Kyushu Cancer Center
 Yasushi Toh, MD, PhD
Ph: 81-92-541-3231
  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
  Kitakyushu-shi
 University of Occupational and Environmental Health
 Naoki Nagata, MD
Ph: 81-93-691-7441
  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 Prefectural Hospital
 Hiroyuki Egi, MD
Ph: 81-82-254-1818
 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
  Sapporo-shi
 Sapporo-Kosei General Hospital
 Yukifumi Kondo, MD, PhD
Ph: 81-11-261-5331
Hyogo
  Akashi
 Akashi Municipal Hospital
 Youichi Kadotani, MD
Ph: 81-78-912-2323
 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
  Itami
 Kinki Central Hospital
 Yoshio Uemura, MD, PhD
Ph: 81-72-781-3712
  Kakogawa
 Kakogawa Municipal Hospital
 Masaaki Mitsutsuji, MD, PhD
  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
 Shakai Hoken Kobe Central Hospital
 Atsushi Oguro, MD
Ph: 81-78-594-2211
  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
  Yamsakicho
 Public Shiso General Hospital
 Shinsuke Satake, MD
Ph: 81-790-62-2410
Ibaraki
  Ibaraki
 National Hospital Organization Mito Medical Center
 Contact Person
Ph: 81-29-240-7711
 Email: koiumim@mito.hosp.go.jp
  Mito
 Mito Saiseikai General Hospital
 Contact Person
Ph: 81-29-254-5151
 Email: takaku@mito-saisei.jp
  Tsuchiura
 Tsuchiura Kyodo General Hospital
 Susumu Hiranuma, MD
Ph: 81-29-823-3111
Ishikawa
  Kahoku-gun
 Kanazawa Medical University
 Shigeki Takashima, MD
Ph: 81-76-286-2211
  Kanazawa
 Kanazawa University Hospital
 Contact Person
Ph: 81-76-265-2362
 Email: hfujita@surg2.m.kanazawa.u.ac.jp
Iwate
  Morioka
 Iwate Medical University Hospital
 Koki Otsuka
Ph: 81-19-651-5111
 Iwate Prefectural Central Hospital
 Contact Person
Ph: 81-19-653-1151
 Email: imochizu@chuo-hp.jp
Kagawa
  Marugame
 Kagawa Rosai Hospital
 Contact Person
Ph: 81-877-23-3111
  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
 Chigasaki Municipal Hospital
 Contact Person
Ph: 81-467-52-1111
 Email: hosp_keiei@city.chigasaki.kanagawa.jp
  Fujisawa-shi
 Fujisawa City Hospital
 Akira Nakano, MD
Ph: 81-466-25-3111
  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
 Nippon Medical School Musashikosugi Hospital
 Tetsuro Matsunobu, MD, PhD
Ph: 81-44-733-5181
 Saint Marianna University School of Medicine
 Contact Person
Ph: 81-44-977-8111
 Email: s2tsuki@marianna-u.ac.jp
  Sagamihara
 Sagamihara National Hospital
 Yasuhiko Nishiyama, MD
Ph: 81-42-742-8311
  Yokohama
 International Goodwill Hospital
 Noriaki Kameyama, MD, PhD
Ph: 81-45-813-0221
 Kanagawa Cancer Center
 Makoto Akaike, MD
Ph: 81-45-391-5761
 Saiseikai Yokohama City Nanbu Hospital
 Hideyuki Ike, MD, PhD
Ph: 81-45-832-1111
 Showa University Fujigaoka Hospital
 Contact Person
Ph: 81-45-971-1151
 Email: kenjih-ngy@umin.ac.jp
 Social Insurance Yokohama Central Hospital
 Contact Person
Ph: 81-45-641-1921
 Email: mimatsu.kenji@yokochu.jp
 St. Marianna University Yokohama City Seibu Hospital
 Contact Person
Ph: 81-45-366-1111
 Email: a2hanai@marianna-u.ac.jp
 Yokohama City Hospital
 Daiduke Minabe, MD
Ph: 81-45-331-1961
 Yokohama City University Medical Center
 Shoichi Fujii, MD
Ph: 81-45-261-5656
 Email: u0970047@urahp.yokohama-cu.ac.jp
  Yokohama-shi
 Showa University Northern Yokohama Hospital
 Shinei Kudo, MD, PhD
Ph: 81-45-949-7000
  Yokosuka
 Yokosuka Kyosai Hospital
 Kaoru Nagahori, MD, PhD
Ph: 81-46-822-2710
 Email: nagakkr@yahoo.co.jp
Kochi
  Kochi
 Kochi Health Sciences Center
 Akihito Tsuji, MD, PhD
Ph: 81-88-837-3000
  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
  Yashiro
 Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
 Katsuhiko Inoue, MD
Ph: 81-965-33-4151
  Yatsushiro
 Yatsushiro Health Insurance General Hospital
 Masafumi Kuramoto, MD
Ph: 81-965-32-71111
Kyoto
  Higashiyama-ku
 Kyoto First Red Cross Hospital
 Hideaki Kurioka, MD
Ph: 81-75-561-1121
  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
 Kyoto-Katsura Hospital
 Dai Manaka, PhD
Ph: 81-75-391-5811
 National Hospital Organization - Kyoto Medical Center
 Contact Person
Ph: 81-75-641-9161
 Email: tayamagu@kyotolan.hosp.go.jp
 Nishijin Hospital
 Takuya Miyagaki, MD, PhD
Ph: 81-75-461-8800
  Nantan
 Nantan General Hospital
 Contact Person
Ph: 81-771-42-2510
 Email: uujil015@kha.biglobe.ne.jp
  Sakyo-ku
 Kyoto University Hospital
 Satoshi Nagayama, MD, PhD
Ph: 81-75-751-3227
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
 Sendai Kousei Hospital
 Contact Person
Ph: 81-22-222-6181
 Email: yamauchi@sendai-kousei-hospital.jp
 Sendai Medical Center
 Toshihiro Saito, MD
Ph: 81-22-293-1111
 Tohoku Rosai Hospital
 Hiroaki Musha, MD
Ph: 81-22-275-1111
 Tohoku University Graduate School of Medicine
 Contact Person
Ph: 81-22-717-7205
 Email: k-miura@surg1.med.tohoku.ac.jp
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-shi
 Nagano Municipal Hospital
 Yasuhiro Munakata, MD
Ph: 81-26-295-1199
  Nakano
 Hokushin Hospital
 Kiyofumi Yamagishi, MD
Ph: 81-269-22-2151
Nagasaki
  Magasaki-shi
 Nagasaki University Hospital of Medicine and Dentistry
 Masashi Haraguchi, MD, PhD
Ph: 81-95-849-7316
  Nagasaki-shi
 Japanese Red Cross Nagasaki Genbaku Hospital
 Takazaki Nakazaki, MD
Ph: 81-95-847-1511
  Omura
 National Hospital Organization Nagasaki Medical Center
 Kousei Miyashita, MD, PhD
Ph: 81-957-52-3121
  Sasebo-shi
 Sasebo City General Hospital
 Hiroshi Ishikawa, MD
Ph: 81-956-24-1515
Nara
  Kashihara
 Nara Medical University Cancer Center
 Tomohide Mukogawa, MD
Ph: 81-744-22-3051
  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
  Nagaoka
 Nagaoka Chuo General Hospital
 Atsushi Nishimura, MD
Ph: 81-258-35-3700
  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
  Kurashiki-shi
 Kawasaki Medical School
 Kazuki Yamashita, MD
Ph: 81-86-462-1111
  Okayama
 Okayama University Medical School
 Nagahide Matsubara, MD
Ph: 81-86-235-7257
Okinawa
  Okinawa
 Nakagami Hospital
 Zenji Miyazato, MD
Ph: 81-98-939-1300
Osaka
  Hirakata
 Hoshigaoka Koseinenkin Hospital
 Mitsutoshi Tatsumi, MD, PhD
Ph: 81-72-840-2641
  Izumiotsu
 Tsunehiro Maeda, MD
Ph: 81-752-32-5622
 Izumiotsu Municipal Hospital
 Contact Person
Ph: 81-752-32-5622
  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
  Moriguchi
 Kansai Medical University Takii Hospital
 Contact Person
Ph: 81-6-6992-1001
 Email: takadahi@takii.kmu.ac.jp
  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
  Osakasayama
 Kinki University School of Medicine
 Kiyotaka Okuno, MD, PhD
Ph: 81-72-366-0221
  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
 Bell Land General Hospital
 Masao Kameyama, MD, PhD
Ph: 81-72-234-2001
 Sakai City Hospital
 Contact Person
Ph: 81-72-221-1700
 Email: fukunaga-m@city.sakai.osaka.jp
  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
Saga
  Saga
 Saga Prefectural Hospital Koseikan
 Contact Person
Ph: 81-952-24-2171
 Email: orita-h@koseikan.jp
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
  Kitamoto
 Kitasato Institute Medical Center Hospital
 Yohei Yasogawa, MD, PhD
Ph: 81-48-593-1212
  Saitama
 Saitama Social Insurance Hospital
 Kohsei Hisa, MD
Ph: 81-48-832-4951
  Saitamaken
 Omiya Medical Center ofJichi Medical School
 Fumio Konishi, MD, PhD
Ph: 81-48-647-2111
 Email: DZD00740@nifty.ne.jp
  Tokorozawa
 National Defense Medical College
 Hideki Ueno, MD, PhD
Ph: 81-42-995-1637
 Email: ueno@ndmc.ac.jp
 National Hospital Organization - Nishisaitama-Chuo National Hospital
 Contact Person
Ph: 81-42-948-1111
 Email: ikeuchik@wsh.hosp.go.jp
Shiga
  Otsu
 Otsu Municipal Hospital
 Ken Yanagibashi, MD, PhD
Ph: 81-77-522-4607
 Email: kenyanagibashi@msn.com
  Otsu-shi
 Shiga University of Medical Science
 Yoshihiro Endo, MD, PhD
Ph: 81-77-548-2238
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
  Sunto-gun
 Shizuoka Cancer Center
 Masayuki Ishii, MD
Ph: 81-55-989-5222
  Yaizu
 Yaizu Municipal Hospital
 Takeyuki Hiramatsu, MD, PhD
Ph: 81-54-623-3111
Tochigi
  Ohtawawa
 Ohtawara Red Cross Hospital
 Hikaru Tamura, MD, PhD
Ph: 81- 287-23-1122
  Shimotsuga-gun
 Dokkyo University School of Medicine
 Masahiro Tsubaki
Ph: 81-282-86-1111
  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
  Bunkyo-ku
 Juntendo University School of Medicine
 Kazuhiro Sakamoto, MD, PhD
Ph: 81-3-3813-3111
  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
  Higashiyamato
 Higashiyamato General Hospital
 Takashi Omura, MD, PhD
Ph: 81-42-562-1411
  Kodaira
 Showa 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
  Meguro-ku
 Toho University Ohashi Hospital
 Yoshihisa Saida, MD, PhD
Ph: 81-3-3468-1251
  Minato-ku
 Toranomon Hospital
 Toshihito Sawada, MD
Ph: 81-3-3588-1111
  Mitaka
 Kyorin University School of Medicine - Mitaka Campus
 Tadahiko Masaki, MD, PhD
Ph: 81-422-47-5511
  Nakano
 Nakano General Hospital
 Ryo Ono, MD, PhD
Ph: 81-3-3382-1231
  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
 Japanese Red Cross Medical Center
 Takeshi Endo, MD
Ph: 81-3-3400-1311
 Jikei University School of Medicine Hospital
 Contact Person
Ph: 81-3-3603-2111
 Email: kaz-yosh@yd5.so-net.ne.jp
 Mita Hospital at the International University of Health and Welfare
 Ken-ichi Mafune, MD
Ph: 81-3-3451-8121
 Email: mafune@iuhw.ac.jp
 National Hospital Organization - Tokyo Medical Center
 Contact Person
Ph: 81-3-3411-0111
 Email: smatsumoto@ntmc.hosp.go.jp
 Nippon Medical School
 Kiyonori Furukawa
Ph: 81-3-3822-2131
 NTT Kanto Medical Center
 Contact Person
Ph: 81-3-3448-6557
 Email: fukusima@kmc.mhc.east.ntt.co.jp
 Showa University Toyosu Hospital
 Contact Person
Ph: 81-3-3534-1151
 Email: noboru.y@med.showa-u.ac.jp
 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
 Kenichi Sugihara, MD, PhD
Ph: 81-3-5803-5261
 Email: k-sugi.srg2@tmd.ac.jp
 Tokyo Metropolitan - Komagome Hospital
 Contact Person
Ph: 81-3-3823-2101
 Email: keiichi@cick.jp
 Tokyo Women's Medical University Medical Center East
 Contact Person
Ph: 81-3-3810-1111
 Email: ogawasu@dnh.twmu.ac.jp
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
  Toyama
 Toyama Red Cross Hospital
 Akira Takehara, MD, PhD
Ph: 81-76-433-2222
  Toyama-shi
 Toyama Prefectural Central Hospital
 Kazuhisa Yabushita, MD, PhD
Ph: 81-76-424-1531
Wakayama
  Shingu
 Shingu Municipal Medical Center
 Contact Person
Ph: 81-735-31-3333
 Email: naoyama@hsp.shingu.wakayama.jp
  Tanabe
 Social Insurance Kinan Hospital
 Makio Nagaoka, MD
Ph: 81-739-22-5000
  Wakayama
 Japan Labor Health and Welfare Organization Wakayama Rosai Hospital
 Contact Person
Ph: 81-73-451-3181
 Email: tks-tsuji@wakayamah.rofuku.go.jp
  Wakayama-shi
 Wakayama Medical University
 Tsukasa Hotta, MD, PhD
Ph: 81-73-441-0613
Yamagata
  Yamagata
 Yamagata Prefectural Central Hospital
 Contact Person
Ph: 81-23-685-2626
 Email: toshi.st@ypch.gr.jp
 Yamagata Saisei Hospital
 Contact Person
Ph: 81-23-682-1111
 Email: urayamam@nirty.com
 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 Randomized Phase III Trial of Adjuvant Chemotherapy with UFT vs. Observation in Curatively Resected Stage II Colon Cancer
Trial Start Date 2006-10-02
Trial Completion Date 2014-09-30 (estimated)
Registered in ClinicalTrials.gov NCT00392899
Date Submitted to PDQ 2006-10-02
Information Last Verified 2009-07-05

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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Department of Health and Human Services National Institutes of Health USA.gov