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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00392899
First received: October 25, 2006
Last updated: December 17, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: tegafur-uracil
Other: clinical observation
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: October 2006
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392899

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

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00392899     History of Changes
Other Study ID Numbers: CDR0000512573, TMDU-BRI-CC-05-01
Study First Received: October 25, 2006
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage II rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014