Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage II colon cancer, stage II rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility 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
Sites / Locations
- Aichi Medical University
- Japanese Red Cross Nagoya First Hospital
- Nagoya City University Hospital
- Nagoya Central Hospital
- Nagoya Ekisaikai Hospital
- Ban Buntane Houtokukai Hospital
- West Medical Center Jouhoku Municipal Hospital
- Aichi Cancer Center
- Nagoya University Hospital
- Nagoya University School of Medicine
- Nagoya Midori Municipal Hospital
- Aichi Cancer Center at Aichi Hospital
- National Hospital Organization Toyohashi Medical Center
- Toyohashi Municipal Hospital
- Koseiren Kamo Hospital
- Yamamoto Kumiai General Hospital
- Hiraka General Hospital
- Asahi General Hospital
- Teikyo University Chiba Medical Center
- Juntendo Urayasu Hospital
- Shikoku Cancer Center
- Sumitomo Besshi Hospital
- Fukuiken Saiseikai Hospital
- University of Fukui Hospital
- Kyushu University Hospital
- University of Occupational and Environmental Health
- Kitakyushu Municipal Medical Center
- Kurume University School of Medicine
- Saint Mary's Hospital
- Social Insurance Tagawa Hospital
- Fukushima Medical University Hospital
- Gifu Municipal Hospital
- Hashima City Hospital
- Ogaki Municipal Hospital
- Gunma University Graduate School of Medicine
- Gunma Cancer Center
- National Hospital Organization Fukuyama Medical Center
- Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
- National Hospital Organization Kure Medical Center
- Miyoshi Central Hospital
- Asahikawa Medical College
- Otaru Ekisaikai Hospital
- Hakodate Goryoukaku Hospital
- Hirosaki University, School of Medicine
- Sapporo-Kosei General Hospital
- Sapporo Medical University
- Sapporo City General Hospital
- Hokkaido University Graduate School of Medicine
- Akashi Municipal Hospital
- Hyogo Cancer Center
- Ako City Hospital
- Hyogo Prefectural Amagasaki Hospital
- Kansai Rosai Hospital
- Himeji St. Mary's Hospital
- Himeji Central Hospital
- Kinki Central Hospital
- Kakogawa Municipal Hospital
- Kobe City General Hospital
- Kobe University Hospital
- Shakai Hoken Kobe Central Hospital
- Nishi-Kobe Medical Center
- Kobe West City Hospital
- Kobe Medical Center
- Sano Hospital
- Hyogo College of Medicine
- Hyogo Prefectural Awaji Hospital
- Higashi Takarazuka Satoh Hospital
- Takarazuka Municipal Hospital
- Public Shiso General Hospital
- Mito Saiseikai General Hospital
- Tsuchiura Kyodo General Hospital
- Kanazawa Medical University
- Kanazawa University Hospital
- Iwate Medical University Hospital
- Iwate Prefectural Central Hospital
- Kagawa Rosai Hospital
- Kagawa University Hospital
- Kagawa Prefectural Central Hospital
- Kanagawa Prefectural Ashigawa-kami Hospital
- Chigasaki Municipal Hospital
- Fujisawa City Hospital
- Kanto Rosai Hospital
- Nippon Medical School Musashikosugi Hospital
- Saint Marianna University School of Medicine
- Sagamihara National Hospital
- Showa University Northern Yokohama Hospital
- Showa University Fujigaoka Hospital
- Social Insurance Yokohama Central Hospital
- Yokohama City University Medical Center
- Saiseikai Yokohama City Nanbu Hospital
- Yokohama City Hospital
- St. Marianna University Yokohama City Seibu Hospital
- Kanagawa Cancer Center
- International Goodwill Hospital
- Yokosuka Kyosai Hospital
- Kochi Medical School
- National Hospital Organization - Kumamotominami Hospital
- Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
- Yatsushiro Health Insurance General Hospital
- Kyoto First Red Cross Hospital
- Kyoto Second Red Cross Hospital
- Nantan General Hospital
- Kyoto University Hospital
- Mie University Graduate School of Medicine
- Miyagi Cancer Center
- Sendai Kousei Hospital
- Tohoku University Graduate School of Medicine
- Tohoku Rosai Hospital
- Sendai Medical Center
- Iida Municipal Hospital
- Showa-Inan General Hospital
- Aizawa Hospital
- Nagano Municipal Hospital
- Hokushin Hospital
- Nagasaki University Hospital
- Japanese Red Cross Nagasaki Genbaku Hospital
- National Hospital Organization Nagasaki Medical Center
- Sasebo City General Hospital
- Nara Medical University Cancer Center
- Kenseikai Nara Coloproctology Center
- Nagaoka Chuo General Hospital
- Niigata University Medical and Dental Hospital
- Niigata Cancer Center Hospital
- Oita University Hospital
- Kawasaki Medical School
- Kurashiki Central Hospital
- Hoshigaoka Koseinenkin Hospital
- Izumiotsu Municipal Hospital
- Rinku General Medical Center
- Minoh City Hospital
- Kansai Medical University Takii Hospital
- Osaka City General Hospital
- Osaka Police Hospital
- Osaka Kosei Nenkin Hospital
- Osaka General Medical Center
- Kinki University School of Medicine
- Osaka Rosai Hospital
- Sakai Municipal Hospital
- Bell Land General Hospital
- Suita Municipal Hospital
- Osaka Medical College
- Saiseikai Tondabayashi Hospital
- Fukaya Red Cross Hospital
- Hasuda Hospital
- Saitama Medical University International Medical Center
- Saitama Medical School Hospital
- Kitasato Institute Medical Center Hospital
- Omiya Medical Center ofJichi Medical School
- National Hospital Organization - Nishisaitama-Chuo National Hospital
- National Defense Medical College
- Shiga University of Medical Science
- Otsu Municipal Hospital
- Shimane Prefectural Central Hospital
- Fujieda Municipal General Hospital
- Hamamatsu University School of Medicine
- Shizuoka Cancer Center
- Yaizu Municipal Hospital
- Ohtawara Red Cross Hospital
- Dokkyo University School of Medicine
- Jichi Medical School
- Tochigi Cancer Center
- Anan Kyoei Hospital
- Juntendo University School of Medicine
- St. Luke's International Hospital
- Tokyo Metropolitan Fuchu Hospital
- Higashiyamato General Hospital
- Tokyo-Kita Social Insurance Hospital
- Showa General Hospital
- Daisan Hospital
- Toho University Ohashi Hospital
- Toranomon Hospital
- Kyorin University School of Medicine - Mitaka Campus
- Nakano General Hospital
- Social Insurance Chuo General Hospital
- Tokyo Women's Medical University
- Tottori University - Faculty of Medicine
- Koseiren Takaoka Hospital
- Toyama Prefectural Central Hospital
- Shingu Municipal Medical Center
- Social Insurance Kinan Hospital
- Wakayama Medical University
- National Hospital Organization - Kanmon Medical Center
- Shimonoseki Kosei Hospital
- Yamaguchi University Graduate School of Medicine
- University of Yamanashi Faculty of Medicine
- Ageo Central General Hospital
- Saiseikai Hiroshima Hospital
- Akita Kumiai General Hospital
- Aomori City Hospital
- Chiba Cancer Center
- Chiba University
- Northern Fukushima Medical Center
- National Hospital Organization Kyushu Medical Center
- National Kyushu Cancer Center
- Matsunami General Hospital
- Chugoku Electric Power Hospital
- Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
- Hiroshima Prefectural Hospital
- Hiroshima University Hospital
- National Hospital Organization Mito Medical Center
- Hokkaido Chuo Rosai Hospital
- Nanpuh Hospital
- Kitasato University School of Medicine
- Osaka Minami Medical Center
- Kiryu Kosei General Hospital
- Kobe Ekisaikai Hospital
- Kochi Health Sciences Center
- Konan Kosei Hospital
- Southern TOHOKU research Institute for Neuroscience
- Kumamoto University Faculty of Medical and Pharmaceutical Sciences
- Japanese Red Cross Kumamoto Hospital
- Kyoto Prefectural University of Medicine
- Nishijin Hospital
- National Hospital Organization - Kyoto Medical Center
- Kyoto-Katsura Hospital
- Saiseikai Matsusaka General Hospital
- Muroran City General Hospital
- Kyoritsu General Hospital
- Nakatsu Municipal Hospital
- Saiseikai Nara Hospital
- Nara Prefectual Nara Hospital
- Saiseikai Niigata Daini Hospital
- Numazu City Hospital
- Oita Prefectural Hospital
- Oita Red Cross Hospital
- Almeida Memorial Hospital
- Okayama University Medical School
- Nakagami Hospital
- Kitano Hospital
- Osaka City Juso Hospital
- Yodogawa Christian Hospital
- Osaka Saiseikai Noe Hospital
- Otemae Hospital
- Osaka Red Cross Hospital
- NTT West Osaka Hospital
- Higashi Sumiyoshi Morimoto Hospital
- Nissay Hospital
- Minamiosaka Hospital
- Saga Prefectural Hospital Koseikan
- Saitama Social Insurance Hospital
- Hakodate Municipal Hospital
- Miyagi Social Insurance Hospital
- Japanese Red Cross Sendai Hospital
- Shizuoka City Hospital
- Shizuoka Municipal Shimizu Hospital
- Kawakita General Hospital
- Niigata Prefectural Tokamachi Hospital
- Tokushima University Hospital
- Mita Hospital at the International University of Health and Welfare
- Tokyo Medical and Dental University
- Nippon Medical School
- Tokyo Metropolitan - Komagome Hospital
- Tokyo Women's Medical University Medical Center East
- Metropolitan Bokutoh Hospital
- Showa University Toyosu Hospital
- NTT Kanto Medical Center
- Toho University School of Medicine
- Japanese Red Cross Medical Center
- National Hospital Organization - Tokyo Medical Center
- International Medical Center of Japan
- Teikyo University School of Medicine
- Jikei University School of Medicine Hospital
- Takasago Kyoritsu Hospital
- Toyama Red Cross Hospital
- Japanese Red Cross Society
- Japan Labor Health and Welfare Organization Wakayama Rosai Hospital
- Yamagata Prefectural Central Hospital
- Yamagata Saisei Hospital
- Yamagata University Hospital
- Saiseikai Yokohamashi Tobu Hospital
- Yokohama City Minato Red Cross Hospital
- Hitachi Yokohama Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
UFT adjuvant therapy group
Observation 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.
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.