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

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 20 to 80 Other TMDU-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

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

Outcomes

Disease-free survival

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

Japan
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
	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
	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
	Toyohashi
	National Hospital Organization Toyohashi Medical Center
		Tooru Ichihara, MD, PhD	Ph:  81-532-62-0301
	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
Chiba
	Asahi-machi
	Asahi General Hospital
		Nobutaka Tanaka, MD, PhD	Ph:  81-479-63-8111
	Inba-gunn
	Nippon Medical School
		Noritake Tanaka, PhD	Ph:  81-476-99-1111
	Urayasu-shi
	Juntendo Urayasu Hospital
		Masaki Fukunaga, MD, PhD	Ph:  81-47-353-3111
			Email: masaki-f@juntendo-urayasui.jp
Ehime
	Niihama-shi
	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 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-shi
	Kitakyushu Municipal Medical Center
		Hiroyuki Konomi, MD, PhD	Ph:  81-93-541-1831
	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-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
	Hiroshima
	Hiroshima Prefectural Hospital
		Hiroyuki Egi, MD	Ph:  81-82-254-1818
	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
	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
		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
	Shakai Hoken Kobe Central Hospital
		Atsushi Oguro, MD	Ph:  81-78-594-2211
	Takarazukai
	Higashi Takarazuka Satoh Hospital
		Atsushi Ohkawa, MD	Ph:  81-797-88-2200
Ibaraki
	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
Iwate
	Morioka
	Iwate Medical University Hospital
		Go Wakabayashi, MD	Ph:  81-19-651-5111
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
	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
	Sagamihara
	Sagamihara National Hospital
		Yasuhiko Nishiyama, MD	Ph:  81-42-742-8311
	Yokohama
	Kanagawa Cancer Center
		Makoto Akaike, MD	Ph:  81-45-391-5761
	Yokohama City University Medical Center
		Shoichi Fujii, MD	Ph:  81-45-261-5656
			Email: u0970047@urahp.yokohama-cu.ac.jp
	Yokohama-shi
	Saiseikai Yokohama City Nanbu Hospital
		Hideyuki Ike, MD, PhD	Ph:  81-45-832-1111
	Showa University Northern Yokohama Hospital
		Shinei Kudo, MD, PhD	Ph:  81-45-949-7000
	Yokosuka-shi
	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
	Yashiro
	Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
		Katsuhiko Inoue, MD	Ph:  81-965-33-4151
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
	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-shi
	Sendai Medical Center
		Toshihiro Saito, MD	Ph:  81-22-293-1111
	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
	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
Niigata
	Nagaoka
	Nagaoka Chuo General Hospital
		Atsushi Nishimura, MD	Ph:  81-258-35-3700
	Niigata-shi
	Niigata Cancer Center Hospital
		Yasumasa Takii, MD