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

September 26, 2016 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer.

PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Drug: UFT adjuvant chemotherapy

Detailed Description

OBJECTIVES:

Primary

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

Secondary

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

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.

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

Study Type

Interventional

Enrollment (Actual)

2025

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Ageo, Japan, 362-8588
    - Ageo Central General Hospital
  - Aki-Gun, Japan, 731-4311
    - Saiseikai Hiroshima Hospital
  - Akita, Japan, 011-0948
    - Akita Kumiai General Hospital
  - Aomori, Japan, 030-0821
    - Aomori City Hospital
  - Chiba, Japan, 260-8717
    - Chiba Cancer Center
  - Chiba, Japan, 260
    - Chiba University
  - Date, Japan, 960-0502
    - Northern Fukushima Medical Center
  - Fukuoka, Japan, 811-1395
    - National Kyushu Cancer Center
  - Fukuoka, Japan, 810-0065
    - National Hospital Organization Kyushu Medical Center
  - Gifu, Japan, 501-6062
    - Matsunami General Hospital
  - Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital
  - Hiroshima, Japan, 734-8530
    - Hiroshima Prefectural Hospital
  - Hiroshima, Japan, 730-8619
    - Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
  - Hiroshima-shi, Japan, 730-8562
    - Chugoku Electric Power Hospital
  - Ibaraki, Japan, 311-3193
    - National Hospital Organization Mito Medical Center
  - Iwamizawa, Japan, 068-0004
    - Hokkaido Chuo Rosai Hospital
  - Kagoshima, Japan, 892-8512
    - Nanpuh Hospital
  - Kanagawa, Japan, 228-8555
    - Kitasato University School of Medicine
  - Kawachinagano, Japan, 586-8521
    - Osaka Minami Medical Center
  - Kiryu, Japan, 376-0024
    - Kiryu Kosei General Hospital
  - Kobe, Japan, 655-0004
    - Kobe Ekisaikai Hospital
  - Kochi, Japan, 781-8555
    - Kochi Health Sciences Center
  - Konan, Japan, 483-8704
    - Konan Kosei Hospital
  - Koriyama-city, Japan, 963-8563
    - Southern Tohoku Research Institute for Neuroscience
  - Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
  - Kumamoto, Japan, 860-8556
    - Kumamoto University Faculty of Medical and Pharmaceutical Sciences
  - Kyoto, Japan, 615-8256
    - Kyoto-Katsura Hospital
  - Kyoto, Japan, 602-0841
    - Kyoto Prefectural University of Medicine
  - Kyoto, Japan, 602
    - Nishijin Hospital
  - Kyoto, Japan, 612-0861
    - National Hospital Organization - Kyoto Medical Center
  - Matsusaka, Japan, 515-0004
    - Saiseikai Matsusaka General Hospital
  - Muroran, Japan, 051-8512
    - Muroran City General Hospital
  - Nagoya, Japan, 456-8611
    - Kyoritsu General Hospital
  - Nakatsu, Japan, 871-0011
    - Nakatsu Municipal Hospital
  - Nara, Japan, 6308145
    - Saiseikai Nara Hospital
  - Nara, Japan, 631-0846
    - Nara Prefectual Nara Hospital
  - Niigata, Japan, 950-1104
    - Saiseikai Niigata Daini Hospital
  - Numazu, Shizuoka, Japan, 410-0302
    - Numazu City Hospital
  - Oita, Japan, 870-0033
    - Oita Red Cross Hospital
  - Oita, Japan, 870-1195
    - Almeida Memorial Hospital
  - Oita-shi, Japan, 870-8511
    - Oita Prefectural Hospital
  - Okayama, Japan, 700-8558
    - Okayama University Medical School
  - Okinawa, Japan, 904-2195
    - Nakagami Hospital
  - Osaka, Japan, 543-8555
    - Osaka Red Cross Hospital
  - Osaka, Japan, 530-8480
    - Kitano Hospital
  - Osaka, Japan, 532-0
    - Osaka City Juso Hospital
  - Osaka, Japan, 533-0032
    - Yodogawa Christian Hospital
  - Osaka, Japan, 536-0002
    - Osaka Saiseikai Noe Hospital
  - Osaka, Japan, 540-0008
    - Otemae Hospital
  - Osaka, Japan, 543-8922
    - NTT WEST Osaka Hospital
  - Osaka, Japan, 546-0012
    - Higashi Sumiyoshi Morimoto Hospital
  - Osaka, Japan, 550-0012
    - Nissay Hospital
  - Osaka, Japan
    - Minamiosaka Hospital
  - Saga, Japan, 840-8571
    - Saga Prefectural Hospital Koseikan
  - Saitama, Japan, 330-0074
    - Saitama Social Insurance Hospital
  - Sendai, Japan, 981-1103
    - Hakodate Municipal Hospital
  - Sendai, Japan, 981-1103
    - Miyagi Social Insurance Hospital
  - Sendai, Japan, 982-8501
    - Japanese Red Cross Sendai Hospital
  - Shizuoka, Japan, 420 -8630
    - Shizuoka City Hospital
  - Shizuoka, Japan, 424-0911
    - Shizuoka Municipal Shimizu Hospital
  - Suginami-ku, Japan, 166-8588
    - Kawakita General Hospital
  - Tokamachi, Japan, 948-0055
    - Niigata Prefectural Tokamachi Hospital
  - Tokushima, Japan, 770-8503
    - Tokushima University Hospital
  - Tokyo, Japan, 113-8519
    - Tokyo Medical and Dental University
  - Tokyo, Japan, 162-8655
    - International Medical Center of Japan
  - Tokyo, Japan, 116-8567
    - Tokyo Women's Medical University Medical Center East
  - Tokyo, Japan, 113-8603
    - Nippon Medical School
  - Tokyo, Japan, 108-8329
    - Mita Hospital at the International University of Health and Welfare
  - Tokyo, Japan, 113-8677
    - Tokyo Metropolitan - Komagome Hospital
  - Tokyo, Japan, 130-8575
    - Metropolitan Bokutoh Hospital
  - Tokyo, Japan, 135-8577
    - Showa University Toyosu Hospital
  - Tokyo, Japan, 141-8625
    - NTT Kanto Medical Center
  - Tokyo, Japan, 143-8541
    - Toho University School of Medicine
  - Tokyo, Japan, 150-8935
    - Japanese Red Cross Medical Center
  - Tokyo, Japan, 152-0021
    - National Hospital Organization - Tokyo Medical Center
  - Tokyo, Japan, 173-8605
    - Teikyo University School of Medicine
  - Tokyo, Japan, 25-8506
    - Jikei University School of Medicine Hospital
  - Tokyo, Japan
    - Takasago Kyoritsu Hospital
  - Toyama, Japan, 930-0859
    - Toyama Red Cross Hospital
  - Wakayama, Japan, 640-8269
    - Japanese Red Cross Society
  - Wakayama, Japan, 640-8435
    - Japan Labor Health and Welfare Organization Wakayama Rosai Hospital
  - Yamagata, Japan, 990-2292
    - Yamagata Prefectural Central Hospital
  - Yamagata, Japan, 990-9585
    - Yamagata University Hospital
  - Yamagata, Japan, 990-8545
    - Yamagata Saisei Hospital
  - Yokohama, Japan, 230-0012
    - Saiseikai Yokohamashi Tobu Hospital
  - Yokohama, Japan, 231-8682
    - Yokohama City Minato Red Cross Hospital
  - Yokohama, Japan, 244-0003
    - Hitachi Yokohama Hospital
- Aichi
  - Aichi-gun, Aichi, Japan, 480-1100
    - Aichi Medical University
  - Nagoya, Aichi, Japan, 464-8681
    - Aichi Cancer Center
  - Nagoya, Aichi, Japan, 454-8502
    - Nagoya Ekisaikai Hospital
  - Nagoya, Aichi, Japan, 453-0801
    - Nagoya Central Hospital
  - Nagoya, Aichi, Japan, 454-8509
    - Ban Buntane Houtokukai Hospital
  - Nagoya, Aichi, Japan, 462-0033
    - West Medical Center Jouhoku Municipal Hospital
  - Nagoya, Aichi, Japan, 466-8550
    - Nagoya University Hospital
  - Nagoya, Aichi, Japan, 466
    - Nagoya University School of Medicine
  - Nagoya, Aichi, Japan
    - Nagoya Midori Municipal Hospital
  - Nagoya-shi, Aichi, Japan, 467-8602
    - Nagoya City University Hospital
  - Nagoya-shi, Aichi, Japan, 453-0046
    - Japanese Red Cross Nagoya First Hospital
  - Okazaki, Aichi, Japan, 444-0011
    - Aichi Cancer Center at Aichi Hospital
  - Toyohashi, Aichi, Japan, 441-8570
    - Toyohashi Municipal Hospital
  - Toyohashi, Aichi, Japan, 440-0836
    - National Hospital Organization Toyohashi Medical Center
  - Toyota, Aichi, Japan, 471-8505
    - Koseiren Kamo Hospital
- Akita
  - Noshiro, Akita, Japan, 016-0014
    - Yamamoto Kumiai General Hospital
  - Yokote, Akita, Japan, 013-8610
    - Hiraka General Hospital
- Chiba
  - Asahi-machi, Chiba, Japan, 289-2511
    - Asahi General Hospital
  - Ichihara, Chiba, Japan, 299-0111
    - Teikyo University Chiba Medical Center
  - Urayasu-shi, Chiba, Japan, 279-0021
    - Juntendo Urayasu Hospital
- Ehime
  - Matsuyama, Ehime, Japan, 790-0007
    - Shikoku Cancer Center
  - Niihama, Ehime, Japan, 792-0008
    - Sumitomo Besshi Hospital
- Fukui
  - Fukui-shi, Fukui, Japan, 918-8503
    - Fukuiken Saiseikai Hospital
  - Yoshida-gun, Fukui, Japan, 910-1193
    - University of Fukui Hospital
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 812-8582
    - Kyushu University Hospital
  - Kitakyushu, Fukuoka, Japan, 802-0077
    - Kitakyushu Municipal Medical Center
  - Kitakyushu-shi, Fukuoka, Japan, 807-8555
    - University of Occupational and Environmental Health
  - Kurume, Fukuoka, Japan, 830-0011
    - Kurume University School of Medicine
  - Kurume, Fukuoka, Japan, 830-8543
    - Saint Mary's Hospital
  - Tagawa, Fukuoka, Japan, 826-8585
    - Social Insurance Tagawa Hospital
- Fukushima
  - Fukushima-shi, Fukushima, Japan, 960-1295
    - Fukushima Medical University Hospital
- Gifu
  - Gifu-shi, Gifu, Japan, 500-8323
    - Gifu Municipal Hospital
  - Hashima, Gifu, Japan, 501-6206
    - Hashima City Hospital
  - Ogaki-shi, Gifu, Japan, 503-8502
    - Ogaki Municipal Hospital
- Gunma
  - Maebashi-shi, Gunma, Japan, 371-8511
    - Gunma University Graduate School of Medicine
  - Otashi, Gunma, Japan, 373-8550
    - Gunma Cancer Center
- Hiroshima
  - Fukuyama, Hiroshima, Japan, 720-0825
    - National Hospital Organization Fukuyama Medical Center
  - Fukuyama, Hiroshima, Japan, 721-8581
    - Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
  - Kure, Hiroshima, Japan, 737-0023
    - National Hospital Organization Kure Medical Center
  - Miyoshi, Hiroshima, Japan, 728-8502
    - Miyoshi Central Hospital
- Hokkaido
  - Asahikawa, Hokkaido, Japan, 078-8510
    - Asahikawa Medical College
  - Asahikawa, Hokkaido, Japan, 078-8510
    - Otaru Ekisaikai Hospital
  - Hakodate, Hokkaido, Japan, 040-8611
    - Hakodate Goryoukaku Hospital
  - Otaru-shi, Hokkaido, Japan, 047-0031
    - Hirosaki University, School of Medicine
  - Sapporo, Hokkaido, Japan, 060-8604
    - Sapporo City General Hospital
  - Sapporo, Hokkaido, Japan, 060-8556
    - Sapporo Medical University
  - Sapporo, Hokkaido, Japan, 060-8638
    - Hokkaido University Graduate School of Medicine
  - Sapporo-shi, Hokkaido, Japan, 060-0033
    - Sapporo-Kosei General Hospital
- Hyogo
  - Akashi, Hyogo, Japan, 673-8558
    - Hyogo Cancer Center
  - Akashi, Hyogo, Japan, 673-8501
    - Akashi Municipal Hospital
  - Akou, Hyogo, Japan, 678-0232
    - Ako City Hospital
  - Amagasaki, Hyogo, Japan, 660-8511
    - Kansai Rosai Hospital
  - Amagasaki, Hyogo, Japan, 660-0828
    - Hyogo Prefectural Amagasaki Hospital
  - Himeji, Hyogo, Japan, 672-8501
    - Himeji Central Hospital
  - Himeji, Hyogo, Japan, 670-0801
    - Himeji St. Mary's Hospital
  - Itami, Hyogo, Japan
    - Kinki Central Hospital
  - Kakogawa, Hyogo, Japan, 675-8611
    - Kakogawa Municipal Hospital
  - Kobe, Hyogo, Japan, 650-0017
    - Kobe University Hospital
  - Kobe, Hyogo, Japan, 651-1145
    - Shakai Hoken Kobe Central Hospital
  - Kobe, Hyogo, Japan, 651-2273
    - Nishi-Kobe Medical Center
  - Kobe, Hyogo, Japan, 653-0013
    - Kobe West City Hospital
  - Kobe, Hyogo, Japan, 654-0155
    - Kobe Medical Center
  - Kobe, Hyogo, Japan, 655-0031
    - Sano Hospital
  - Kobe-shi, Hyogo, Japan, 650-0046
    - Kobe City General Hospital
  - Nishinomiya, Hyogo, Japan, 663-8501
    - Hyogo College of Medicine
  - Sumoto, Hyogo, Japan, 656-0013
    - Hyogo Prefectural AWAJI Hospital
  - Takarazuka, Hyogo, Japan, 665-0827
    - Takarazuka Municipal Hospital
  - Takarazukai, Hyogo, Japan, 665-0873
    - Higashi Takarazuka Satoh Hospital
  - Yamsakicho, Hyogo, Japan
    - Public Shiso General Hospital
- Ibaraki
  - Mito, Ibaraki, Japan, 311-4198
    - Mito Saiseikai General Hospital
  - Tsuchiura, Ibaraki, Japan, 300-0053
    - Tsuchiura Kyodo General Hospital
- Ishikawa
  - Kahoku-gun, Ishikawa, Japan, 920-0265
    - Kanazawa Medical University
  - Kanazawa, Ishikawa, Japan, 920-8641
    - Kanazawa University Hospital
- Iwate
  - Morioka, Iwate, Japan, 020-8505
    - Iwate Medical University Hospital
  - Morioka, Iwate, Japan, 020-8505
    - Iwate Prefectural Central Hospital
- Kagawa
  - Marugame, Kagawa, Japan, 763-8502
    - Kagawa Rosai Hospital
  - Miki, Kagawa, Japan, 761-0793
    - Kagawa University Hospital
  - Takamatsu, Kagawa, Japan, 760-8557
    - Kagawa Prefectural Central Hospital
- Kanagawa
  - Ashigarakami-gun, Kanagawa, Japan, 258-0003
    - Kanagawa Prefectural Ashigawa-kami Hospital
  - Chigasaki, Kanagawa, Japan, 253-0083
    - Chigasaki Municipal Hospital
  - Fujisawa-shi, Kanagawa, Japan, 251-8550
    - Fujisawa City Hospital
  - Kawasaki, Kanagawa, Japan, 211-8510
    - Kanto Rosai Hospital
  - Kawasaki, Kanagawa, Japan, 211-8533
    - Nippon Medical School Musashikosugi Hospital
  - Kawasaki, Kanagawa, Japan, 216-8511
    - Saint Marianna University School of Medicine
  - Sagamihara, Kanagawa, Japan, 228-8522
    - Sagamihara National Hospital
  - Yokohama, Kanagawa, Japan, 232-0024
    - Yokohama City University Medical Center
  - Yokohama, Kanagawa, Japan, 241-0815
    - Kanagawa Cancer Center
  - Yokohama, Kanagawa, Japan, 245-0006
    - International Goodwill Hospital
  - Yokohama, Kanagawa, Japan, 227-8502
    - Showa University Fujigaoka Hospital
  - Yokohama, Kanagawa, Japan, 231-8553
    - Social Insurance Yokohama Central Hospital
  - Yokohama, Kanagawa, Japan, 234-8503
    - Saiseikai Yokohama City Nanbu Hospital
  - Yokohama, Kanagawa, Japan, 240
    - Yokohama City Hospital
  - Yokohama, Kanagawa, Japan, 241-0811
    - St. Marianna University Yokohama City Seibu Hospital
  - Yokohama-shi, Kanagawa, Japan, 224-8503
    - Showa University Northern Yokohama Hospital
  - Yokosuka, Kanagawa, Japan, 238-8558
    - Yokosuka Kyosai Hospital
- Kochi
  - Nankoku, Kochi, Japan, 783-8505
    - Kochi Medical School
- Kumamoto
  - Uki, Kumamoto, Japan, 869-0
    - National Hospital Organization - Kumamotominami Hospital
  - Yashiro, Kumamoto, Japan, 866-0826
    - Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
  - Yatsushiro, Kumamoto, Japan, 866-8660
    - Yatsushiro Health Insurance General Hospital
- Kyoto
  - Higashiyama-ku, Kyoto, Japan, 605-0981
    - Kyoto First Red Cross Hospital
  - Kanigyou-ku, Kyoto, Japan, 602-8026
    - Kyoto Second Red Cross Hospital
  - Nantan, Kyoto, Japan, 629-0197
    - Nantan General Hospital
  - Sakyo-ku, Kyoto, Japan, 606-8507
    - Kyoto University Hospital
- Mie
  - Thu-shi, Mie, Japan, 514-8507
    - Mie University Graduate School Of Medicine
- Miyagi
  - Natori-shi, Miyagi, Japan, 981-1293
    - Miyagi Cancer Center
  - Sendai, Miyagi, Japan, 980-0873
    - Sendai Kousei Hospital
  - Sendai, Miyagi, Japan, 983-8520
    - Sendai Medical Center
  - Sendai, Miyagi, Japan, 980-8574
    - Tohoku University Graduate School of Medicine
  - Sendai, Miyagi, Japan, 981-0911
    - Tohoku Rosai Hospital
- Nagano
  - Iida, Nagano, Japan, 395-8502
    - Iida Municipal Hospital
  - Komagane, Nagano, Japan, 399-4191
    - Showa-Inan General Hospital
  - Matsumoto, Nagano, Japan, 390-8510
    - Aizawa Hospital
  - Nagano-shi, Nagano, Japan, 381-8551
    - Nagano Municipal Hospital
  - Nakano, Nagano, Japan, 383-0021
    - Hokushin Hospital
- Nagasaki
  - Magasaki-shi, Nagasaki, Japan, 852-8501
    - Nagasaki University Hospital
  - Nagasaki-shi, Nagasaki, Japan, 852-8511
    - Japanese Red Cross Nagasaki Genbaku Hospital
  - Omura, Nagasaki, Japan, 856-8562
    - National Hospital Organization Nagasaki Medical Center
  - Sasebo-shi, Nagasaki, Japan, 857-8511
    - Sasebo City General Hospital
- Nara
  - Kashihara, Nara, Japan, 634-8522
    - Nara Medical University Cancer Center
  - Yamatotakada, Nara, Japan, 635-0022
    - Kenseikai Nara Coloproctology Center
- Niigata
  - Nagaoka, Niigata, Japan, 940-8653
    - Nagaoka Chuo General Hospital
  - Niigata-shi, Niigata, Japan, 951-8566
    - Niigata Cancer Center Hospital
  - Niigata-shi, Niigata, Japan, 951-8122
    - Niigata University Medical and Dental Hospital
- Oita
  - Yufu-shi, Oita, Japan, 879-5593
    - Oita University Hospital
- Okayama
  - Kurashiki, Okayama, Japan, 710-8602
    - Kurashiki Central Hospital
  - Kurashiki-shi, Okayama, Japan, 701-0192
    - Kawasaki Medical School
- Osaka
  - Hirakata, Osaka, Japan, 573-8511
    - Hoshigaoka Koseinenkin Hospital
  - Izumiotsu, Osaka, Japan, 595
    - Izumiotsu Municipal Hospital
  - Izumisano, Osaka, Japan, 598-8577
    - Rinku General Medical Center
  - Mino, Osaka, Japan, 562-0014
    - Minoh City Hospital
  - Moriguchi, Osaka, Japan, 570-8507
    - Kansai Medical University Takii Hospital
  - Osaka-shi, Osaka, Japan, 534-0021
    - Osaka City General Hospital
  - Osaka-shi, Osaka, Japan, 543-8502
    - Osaka Police Hospital
  - Osaka-shi, Osaka, Japan, 553-0003
    - Osaka Kosei Nenkin Hospital
  - Osaka-shi, Osaka, Japan, 558-8558
    - Osaka General Medical Center
  - Osakasayama, Osaka, Japan, 589-8511
    - Kinki University School of Medicine
  - Sakai, Osaka, Japan, 590-0064
    - Sakai Municipal Hospital
  - Sakai, Osaka, Japan, 599-8247
    - Bell Land General Hospital
  - Sakai-shi, Osaka, Japan, 591-8025
    - Osaka Rosai Hospital
  - Suita-shi, Osaka, Japan, 564-0082
    - Suita Municipal Hospital
  - Takatsuki, Osaka, Japan, 569-8686
    - Osaka Medical College
  - Tondabayashi, Osaka, Japan, 584-0082
    - Saiseikai tondabayashi Hospital
- Saitama
  - Fukaya, Saitama, Japan, 366-0052
    - Fukaya Red Cross Hospital
  - Hasuda, Saitama, Japan, 349-0123
    - Hasuda Hospital
  - Hidaka, Saitama, Japan, 350-1241
    - Saitama Medical University International Medical Center
  - Kawagoe-shi, Saitama, Japan, 350-8550
    - Saitama Medical School Hospital
  - Kitamoto, Saitama, Japan, 3648501
    - Kitasato Institute Medical Center Hospital
  - Saitamaken, Saitama, Japan, 330-8503
    - Omiya Medical Center ofJichi Medical School
  - Tokorozawa, Saitama, Japan, 359-1151
    - National Hospital Organization - Nishisaitama-Chuo National Hospital
  - Tokorozawa, Saitama, Japan, 359-8513
    - National Defense Medical College
- Shiga
  - Otsu, Shiga, Japan, 520-0804
    - Otsu Municipal Hospital
  - Otsu-shi, Shiga, Japan, 520-2192
    - Shiga University of Medical Science
- Shimane
  - Izumo-shi, Shimane, Japan, 693-0068
    - Shimane Prefectural Central Hospital
- Shizuoka
  - Fujieda, Shizuoka, Japan, 426-8677
    - Fujieda Municipal General Hospital
  - Hamamatsu-shi, Shizuoka, Japan, 431-3192
    - Hamamatsu University School of Medicine
  - Sunto-gun, Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
  - Yaizu, Shizuoka, Japan, 425-8505
    - Yaizu Municipal Hospital
- Tochigi
  - Ohtawawa, Tochigi, Japan, 324-0
    - Ohtawara Red Cross Hospital
  - Shimotsuga-gun, Tochigi, Japan, 321-0293
    - Dokkyo University School of Medicine
  - Shimotsuke-shi, Tochigi, Japan, 329-0498
    - Jichi Medical School
  - Utsunomiya, Tochigi, Japan, 320-0834
    - Tochigi Cancer Center
- Tokushima
  - Anan, Tokushima, Japan, 770-8503
    - Anan Kyoei Hospital
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-0033
    - Juntendo University School of Medicine
  - Chuo-ku, Tokyo, Japan, 104-8560
    - St. Luke's International Hospital
  - Fuchu, Tokyo, Japan, 183-8524
    - Tokyo Metropolitan Fuchu Hospital
  - Higashiyamato, Tokyo, Japan, 207-0014
    - Higashiyamato General Hospital
  - Kita-ku, Tokyo, Japan, 115-0053
    - Tokyo-kita Social Insurance Hospital
  - Kodaira, Tokyo, Japan, 187-8510
    - Showa General Hospital
  - Komae, Tokyo, Japan, 201
    - Daisan Hospital
  - Meguro-ku, Tokyo, Japan, 153-8515
    - Toho University Ohashi Hospital
  - Minato-ku, Tokyo, Japan, 105-8470
    - Toranomon Hospital
  - Mitaka, Tokyo, Japan, 181-8611
    - Kyorin University School of Medicine - Mitaka Campus
  - Nakano, Tokyo, Japan, 164-8607
    - Nakano General Hospital
  - Shinjuku-ku, Tokyo, Japan, 169-0073
    - Social Insurance Chuo General Hospital
  - Shinjyuku-ku, Tokyo, Japan, 162-8666
    - Tokyo Women's Medical University
- Tottori
  - Yonago, Tottori, Japan, 683-8503
    - Tottori University - Faculty of Medicine
- Toyama
  - Takaoka-shi, Toyama, Japan, 933-8555
    - Koseiren Takaoka Hospital
  - Toyama-shi, Toyama, Japan, 930-8550
    - Toyama Prefectural Central Hospital
- Wakayama
  - Shingu, Wakayama, Japan, 647-0072
    - Shingu Municipal Medical Center
  - Tanabe, Wakayama, Japan, 646-8588
    - Social Insurance Kinan Hospital
  - Wakayama-shi, Wakayama, Japan, 641-8509
    - Wakayama Medical University
- Yamaguchi
  - Shimonoseki, Yamaguchi, Japan, 750-0061
    - Shimonoseki Kosei Hospital
  - Shimonoseki, Yamaguchi, Japan, 240-8555
    - National Hospital Organization - Kanmon Medical Center
  - Ube, Yamaguchi, Japan, 755-8505
    - Yamaguchi University Graduate School of Medicine
- Yamanashi
  - Chu-o-shi, Yamanashi, Japan, 409-3898
    - University of Yamanashi Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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

PRIOR CONCURRENT THERAPY:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UFT adjuvant therapy group UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.	Drug: UFT adjuvant chemotherapy UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. Other Names: Adjuvant chemotherapy with tegafur-uracil
No Intervention: Observation group Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.

Participant Group / Arm

Intervention / Treatment

Active Comparator: UFT adjuvant therapy group

UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year. During protocol treatment, clinical findings and laboratory values are evaluated every month. After the completion of protocol treatment, patients are followed-up, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.

Drug: UFT adjuvant chemotherapy

UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.

Other Names:

Adjuvant chemotherapy with tegafur-uracil

No Intervention: Observation group

Patients are followed-up without adjuvant treatment, according to the schedule defined in the study protocol, for 5 years until recurrence, other malignancy or death is confirmed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival Time Frame: 9 years	Disease-free survival is defined as the time from date of enrollement until date of recurrence, other malignancies or death from any cause, whichever comes first.	9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: 9 years	Overall survival is defined as time from date of enrollment until date of death from any cause.	9 years
Types and severities of adverse events Time Frame: 15 months	Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.	15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Tokyo Medical and Dental University

Investigators

Study Chair: Kenichi Sugihara, MD, PhD, Tokyo Medical and Dental University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000512573
TMDU-BRI-CC-05-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers