Clinical trial NCT00392899: Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Official title: Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: stage II colon cancer
stage II rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Tokyo Medical and Dental University
First posted: 2006-10-26
Enrollment: 2025
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 9 years
Secondary outcomes:
measure: Overall survival
timeFrame: 9 years
measure: Types and severities of adverse events
timeFrame: 15 months
Other outcomes:
Locations:
city: Aichi-gun
country: Japan
facility: Aichi Medical University
state: Aichi
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Nagoya First Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Central Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Ekisaikai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Ban Buntane Houtokukai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: West Medical Center Jouhoku Municipal Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University School of Medicine
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Midori Municipal Hospital
state: Aichi
city: Okazaki
country: Japan
facility: Aichi Cancer Center at Aichi Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: National Hospital Organization Toyohashi Medical Center
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Toyota
country: Japan
facility: Koseiren Kamo Hospital
state: Aichi
city: Noshiro
country: Japan
facility: Yamamoto Kumiai General Hospital
state: Akita
city: Yokote
country: Japan
facility: Hiraka General Hospital
state: Akita
city: Asahi-machi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Ichihara
country: Japan
facility: Teikyo University Chiba Medical Center
state: Chiba
city: Urayasu-shi
country: Japan
facility: Juntendo Urayasu Hospital
state: Chiba
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Niihama
country: Japan
facility: Sumitomo Besshi Hospital
state: Ehime
city: Fukui-shi
country: Japan
facility: Fukuiken Saiseikai Hospital
state: Fukui
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: University of Occupational and Environmental Health
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Kurume
country: Japan
facility: Saint Mary's Hospital
state: Fukuoka
city: Tagawa
country: Japan
facility: Social Insurance Tagawa Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Hashima
country: Japan
facility: Hashima City Hospital
state: Gifu
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Graduate School of Medicine
state: Gunma
city: Otashi
country: Japan
facility: Gunma Cancer Center
state: Gunma
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center
state: Hiroshima
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
state: Hiroshima
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Miyoshi
country: Japan
facility: Miyoshi Central Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa Medical College
state: Hokkaido
city: Asahikawa
country: Japan
facility: Otaru Ekisaikai Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hospital
state: Hokkaido
city: Otaru-shi
country: Japan
facility: Hirosaki University, School of Medicine
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Graduate School of Medicine
state: Hokkaido
city: Akashi
country: Japan
facility: Akashi Municipal Hospital
state: Hyogo
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Akou
country: Japan
facility: Ako City Hospital
state: Hyogo
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
state: Hyogo
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Himeji
country: Japan
facility: Himeji St. Mary's Hospital
state: Hyogo
city: Himeji
country: Japan
facility: Himeji Central Hospital
state: Hyogo
city: Itami
country: Japan
facility: Kinki Central Hospital
state: Hyogo
city: Kakogawa
country: Japan
facility: Kakogawa Municipal Hospital
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Shakai Hoken Kobe Central Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Nishi-Kobe Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe West City Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Sano Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Sumoto
country: Japan
facility: Hyogo Prefectural Awaji Hospital
state: Hyogo
city: Takarazukai
country: Japan
facility: Higashi Takarazuka Satoh Hospital
state: Hyogo
city: Takarazuka
country: Japan
facility: Takarazuka Municipal Hospital
state: Hyogo
city: Yamsakicho
country: Japan
facility: Public Shiso General Hospital
state: Hyogo
city: Mito
country: Japan
facility: Mito Saiseikai General Hospital
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
state: Iwate
city: Marugame
country: Japan
facility: Kagawa Rosai Hospital
state: Kagawa
city: Miki
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Ashigarakami-gun
country: Japan
facility: Kanagawa Prefectural Ashigawa-kami Hospital
state: Kanagawa
city: Chigasaki
country: Japan
facility: Chigasaki Municipal Hospital
state: Kanagawa
city: Fujisawa-shi
country: Japan
facility: Fujisawa City Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Saint Marianna University School of Medicine
state: Kanagawa
city: Sagamihara
country: Japan
facility: Sagamihara National Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Showa University Fujigaoka Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Social Insurance Yokohama Central Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohama City Nanbu Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: St. Marianna University Yokohama City Seibu Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama
country: Japan
facility: International Goodwill Hospital
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Nankoku
country: Japan
facility: Kochi Medical School
state: Kochi
city: Uki
country: Japan
facility: National Hospital Organization - Kumamotominami Hospital
state: Kumamoto
city: Yashiro
country: Japan
facility: Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
state: Kumamoto
city: Yatsushiro
country: Japan
facility: Yatsushiro Health Insurance General Hospital
state: Kumamoto
city: Higashiyama-ku
country: Japan
facility: Kyoto First Red Cross Hospital
state: Kyoto
city: Kanigyou-ku
country: Japan
facility: Kyoto Second Red Cross Hospital
state: Kyoto
city: Nantan
country: Japan
facility: Nantan General Hospital
state: Kyoto
city: Sakyo-ku
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Thu-shi
country: Japan
facility: Mie University Graduate School of Medicine
state: Mie
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku University Graduate School of Medicine
state: Miyagi
city: Sendai
country: Japan
facility: Tohoku Rosai Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Medical Center
state: Miyagi
city: Iida
country: Japan
facility: Iida Municipal Hospital
state: Nagano
city: Komagane
country: Japan
facility: Showa-Inan General Hospital
state: Nagano
city: Matsumoto
country: Japan
facility: Aizawa Hospital
state: Nagano
city: Nagano-shi
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Nakano
country: Japan
facility: Hokushin Hospital
state: Nagano
city: Magasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Nagasaki-shi
country: Japan
facility: Japanese Red Cross Nagasaki Genbaku Hospital
state: Nagasaki
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Sasebo City General Hospital
state: Nagasaki
city: Kashihara
country: Japan
facility: Nara Medical University Cancer Center
state: Nara
city: Yamatotakada
country: Japan
facility: Kenseikai Nara Coloproctology Center
state: Nara
city: Nagaoka
country: Japan
facility: Nagaoka Chuo General Hospital
state: Niigata
city: Niigata-shi
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita
city: Kurashiki-shi
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Hirakata
country: Japan
facility: Hoshigaoka Koseinenkin Hospital
state: Osaka
city: Izumiotsu
country: Japan
facility: Izumiotsu Municipal Hospital
state: Osaka
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Mino
country: Japan
facility: Minoh City Hospital
state: Osaka
city: Moriguchi
country: Japan
facility: Kansai Medical University Takii Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Police Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Kosei Nenkin Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Osakasayama
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai-shi
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Sakai
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Sakai
country: Japan
facility: Bell Land General Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Suita Municipal Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical College
state: Osaka
city: Tondabayashi
country: Japan
facility: Saiseikai Tondabayashi Hospital
state: Osaka
city: Fukaya
country: Japan
facility: Fukaya Red Cross Hospital
state: Saitama
city: Hasuda
country: Japan
facility: Hasuda Hospital
state: Saitama
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Kawagoe-shi
country: Japan
facility: Saitama Medical School Hospital
state: Saitama
city: Kitamoto
country: Japan
facility: Kitasato Institute Medical Center Hospital
state: Saitama
city: Saitamaken
country: Japan
facility: Omiya Medical Center ofJichi Medical School
state: Saitama
city: Tokorozawa
country: Japan
facility: National Hospital Organization - Nishisaitama-Chuo National Hospital
state: Saitama
city: Tokorozawa
country: Japan
facility: National Defense Medical College
state: Saitama
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science
state: Shiga
city: Otsu
country: Japan
facility: Otsu Municipal Hospital
state: Shiga
city: Izumo-shi
country: Japan
facility: Shimane Prefectural Central Hospital
state: Shimane
city: Fujieda
country: Japan
facility: Fujieda Municipal General Hospital
state: Shizuoka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Yaizu
country: Japan
facility: Yaizu Municipal Hospital
state: Shizuoka
city: Ohtawawa
country: Japan
facility: Ohtawara Red Cross Hospital
state: Tochigi
city: Shimotsuga-gun
country: Japan
facility: Dokkyo University School of Medicine
state: Tochigi
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical School
state: Tochigi
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Anan
country: Japan
facility: Anan Kyoei Hospital
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Juntendo University School of Medicine
state: Tokyo
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Fuchu Hospital
state: Tokyo
city: Higashiyamato
country: Japan
facility: Higashiyamato General Hospital
state: Tokyo
city: Kita-ku
country: Japan
facility: Tokyo-Kita Social Insurance Hospital
state: Tokyo
city: Kodaira
country: Japan
facility: Showa General Hospital
state: Tokyo
city: Komae
country: Japan
facility: Daisan Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University School of Medicine - Mitaka Campus
state: Tokyo
city: Nakano
country: Japan
facility: Nakano General Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Social Insurance Chuo General Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University - Faculty of Medicine
state: Tottori
city: Takaoka-shi
country: Japan
facility: Koseiren Takaoka Hospital
state: Toyama
city: Toyama-shi
country: Japan
facility: Toyama Prefectural Central Hospital
state: Toyama
city: Shingu
country: Japan
facility: Shingu Municipal Medical Center
state: Wakayama
city: Tanabe
country: Japan
facility: Social Insurance Kinan Hospital
state: Wakayama
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University
state: Wakayama
city: Shimonoseki
country: Japan
facility: National Hospital Organization - Kanmon Medical Center
state: Yamaguchi
city: Shimonoseki
country: Japan
facility: Shimonoseki Kosei Hospital
state: Yamaguchi
city: Ube
country: Japan
facility: Yamaguchi University Graduate School of Medicine
state: Yamaguchi
city: Chu-o-shi
country: Japan
facility: University of Yamanashi Faculty of Medicine
state: Yamanashi
city: Ageo
country: Japan
facility: Ageo Central General Hospital
city: Aki-Gun
country: Japan
facility: Saiseikai Hiroshima Hospital
city: Akita
country: Japan
facility: Akita Kumiai General Hospital
city: Aomori
country: Japan
facility: Aomori City Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: Chiba University
city: Date
country: Japan
facility: Northern Fukushima Medical Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center
city: Gifu
country: Japan
facility: Matsunami General Hospital
city: Hiroshima-shi
country: Japan
facility: Chugoku Electric Power Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Ibaraki
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Iwamizawa
country: Japan
facility: Hokkaido Chuo Rosai Hospital
city: Kagoshima
country: Japan
facility: Nanpuh Hospital
city: Kanagawa
country: Japan
facility: Kitasato University School of Medicine
city: Kawachinagano
country: Japan
facility: Osaka Minami Medical Center
city: Kiryu
country: Japan
facility: Kiryu Kosei General Hospital
city: Kobe
country: Japan
facility: Kobe Ekisaikai Hospital
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
city: Konan
country: Japan
facility: Konan Kosei Hospital
city: Koriyama-city
country: Japan
facility: Southern TOHOKU research Institute for Neuroscience
city: Kumamoto
country: Japan
facility: Kumamoto University Faculty of Medical and Pharmaceutical Sciences
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Nishijin Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization - Kyoto Medical Center
city: Kyoto
country: Japan
facility: Kyoto-Katsura Hospital
city: Matsusaka
country: Japan
facility: Saiseikai Matsusaka General Hospital
city: Muroran
country: Japan
facility: Muroran City General Hospital
city: Nagoya
country: Japan
facility: Kyoritsu General Hospital
city: Nakatsu
country: Japan
facility: Nakatsu Municipal Hospital
city: Nara
country: Japan
facility: Saiseikai Nara Hospital
city: Nara
country: Japan
facility: Nara Prefectual Nara Hospital
city: Niigata
country: Japan
facility: Saiseikai Niigata Daini Hospital
city: Numazu, Shizuoka
country: Japan
facility: Numazu City Hospital
city: Oita-shi
country: Japan
facility: Oita Prefectural Hospital
city: Oita
country: Japan
facility: Oita Red Cross Hospital
city: Oita
country: Japan
facility: Almeida Memorial Hospital
city: Okayama
country: Japan
facility: Okayama University Medical School
city: Okinawa
country: Japan
facility: Nakagami Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Osaka City Juso Hospital
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Noe Hospital
city: Osaka
country: Japan
facility: Otemae Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: NTT West Osaka Hospital
city: Osaka
country: Japan
facility: Higashi Sumiyoshi Morimoto Hospital
city: Osaka
country: Japan
facility: Nissay Hospital
city: Osaka
country: Japan
facility: Minamiosaka Hospital
city: Saga
country: Japan
facility: Saga Prefectural Hospital Koseikan
city: Saitama
country: Japan
facility: Saitama Social Insurance Hospital
city: Sendai
country: Japan
facility: Hakodate Municipal Hospital
city: Sendai
country: Japan
facility: Miyagi Social Insurance Hospital
city: Sendai
country: Japan
facility: Japanese Red Cross Sendai Hospital
city: Shizuoka
country: Japan
facility: Shizuoka City Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Municipal Shimizu Hospital
city: Suginami-ku
country: Japan
facility: Kawakita General Hospital
city: Tokamachi
country: Japan
facility: Niigata Prefectural Tokamachi Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Mita Hospital at the International University of Health and Welfare
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo
country: Japan
facility: Nippon Medical School
city: Tokyo
country: Japan
facility: Tokyo Metropolitan - Komagome Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Medical Center East
city: Tokyo
country: Japan
facility: Metropolitan Bokutoh Hospital
city: Tokyo
country: Japan
facility: Showa University Toyosu Hospital
city: Tokyo
country: Japan
facility: NTT Kanto Medical Center
city: Tokyo
country: Japan
facility: Toho University School of Medicine
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Tokyo
country: Japan
facility: National Hospital Organization - Tokyo Medical Center
city: Tokyo
country: Japan
facility: International Medical Center of Japan
city: Tokyo
country: Japan
facility: Teikyo University School of Medicine
city: Tokyo
country: Japan
facility: Jikei University School of Medicine Hospital
city: Tokyo
country: Japan
facility: Takasago Kyoritsu Hospital
city: Toyama
country: Japan
facility: Toyama Red Cross Hospital
city: Wakayama
country: Japan
facility: Japanese Red Cross Society
city: Wakayama
country: Japan
facility: Japan Labor Health and Welfare Organization Wakayama Rosai Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yamagata
country: Japan
facility: Yamagata Saisei Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Yokohama
country: Japan
facility: Hitachi Yokohama Hospital
Study officials:
affiliation: Tokyo Medical and Dental University
name: Kenichi Sugihara, MD, PhD
role: STUDY_CHAIR
References:
citation: Ueno H, Ishiguro M, Nakatani E, Ishikawa T, Uetake H, Matsuda C, Nakamoto Y, Kotake M, Kurachi K, Egawa T, Yasumasa K, Murata K, Ikawa O, Shinji S, Murotani K, Matsui S, Teramukai S, Tomita N, Sugihara K; SACURA Study Group. Prospective Multicenter Study on the Prognostic and Predictive Impact of Tumor Budding in Stage II Colon Cancer: Results From the SACURA Trial. J Clin Oncol. 2019 Aug 1;37(22):1886-1894. doi: 10.1200/JCO.18.02059. Epub 2019 Jun 10.
citation: Matsuda C, Ishiguro M, Teramukai S, Kajiwara Y, Fujii S, Kinugasa Y, Nakamoto Y, Kotake M, Sakamoto Y, Kurachi K, Maeda A, Komori K, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M, Mochizuki H, Nakagawa Y, Sugihara K; SACURA Study Group. A randomised-controlled trial of 1-year adjuvant chemotherapy with oral tegafur-uracil versus surgery alone in stage II colon cancer: SACURA trial. Eur J Cancer. 2018 Jun;96:54-63. doi: 10.1016/j.ejca.2018.03.009. Epub 2018 Apr 17.
citation: Ishiguro M, Mochizuki H, Tomita N, Shimada Y, Takahashi K, Kotake K, Watanabe M, Kanemitsu Y, Ueno H, Ishikawa T, Uetake H, Matsui S, Teramukai S, Sugihara K. Study protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as adjuvant chemotherapy for stage II colon cancer. BMC Cancer. 2012 Jul 7;12:281. doi: 10.1186/1471-2407-12-281.