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

NCT ID: NCT00392899

Last Updated: 2016-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2025 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

UFT adjuvant chemotherapy

Intervention Type DRUG

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Adjuvant chemotherapy with tegafur-uracil

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo Medical and Dental University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenichi Sugihara, MD, PhD

Role: STUDY_CHAIR

Tokyo Medical and Dental University

Locations

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Aichi Medical University

Aichi-gun, Aichi-ken, Japan

Site Status

Japanese Red Cross Nagoya First Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya Central Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya Ekisaikai Hospital

Nagoya, Aichi-ken, Japan

Site Status

Ban Buntane Houtokukai Hospital

Nagoya, Aichi-ken, Japan

Site Status

West Medical Center Jouhoku Municipal Hospital

Nagoya, Aichi-ken, Japan

Site Status

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Site Status

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya University School of Medicine

Nagoya, Aichi-ken, Japan

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Nagoya Midori Municipal Hospital

Nagoya, Aichi-ken, Japan

Site Status

Aichi Cancer Center at Aichi Hospital

Okazaki, Aichi-ken, Japan

Site Status

National Hospital Organization Toyohashi Medical Center

Toyohashi, Aichi-ken, Japan

Site Status

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Site Status

Koseiren Kamo Hospital

Toyota, Aichi-ken, Japan

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Akita Kumiai General Hospital

Akita, Akita, Japan

Site Status

Yamamoto Kumiai General Hospital

Noshiro, Akita, Japan

Site Status

Hiraka General Hospital

Yokote, Akita, Japan

Site Status

Aomori City Hospital

Aomori, Aomori, Japan

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Asahi General Hospital

Asahi-machi, Chiba, Japan

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Chiba Cancer Center

Chiba, Chiba, Japan

Site Status

Chiba University

Chiba, Chiba, Japan

Site Status

Teikyo University Chiba Medical Center

Ichihara, Chiba, Japan

Site Status

Juntendo Urayasu Hospital

Urayasu-shi, Chiba, Japan

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Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status

Sumitomo Besshi Hospital

Niihama, Ehime, Japan

Site Status

Fukuiken Saiseikai Hospital

Fukui-shi, Fukui, Japan

Site Status

University of Fukui Hospital

Yoshida-gun, Fukui, Japan

Site Status

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Site Status

National Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status

Kitakyushu Municipal Medical Center

Kitakyushu, Fukuoka, Japan

Site Status

University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan

Site Status

Kurume University School of Medicine

Kurume, Fukuoka, Japan

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Saint Mary's Hospital

Kurume, Fukuoka, Japan

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Social Insurance Tagawa Hospital

Tagawa, Fukuoka, Japan

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Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

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Gifu Municipal Hospital

Gifu, Gifu, Japan

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Matsunami General Hospital

Gifu, Gifu, Japan

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Hashima City Hospital

Hashima, Gifu, Japan

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Ogaki Municipal Hospital

Ogaki-shi, Gifu, Japan

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Gunma University Graduate School of Medicine

Maebashi, Gunma, Japan

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Gunma Cancer Center

Otashi, Gunma, Japan

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National Hospital Organization Fukuyama Medical Center

Fukuyama, Hiroshima, Japan

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Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuyama, Hiroshima, Japan

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Hiroshima Prefectural Hospital

Hiroshima, Hiroshima, Japan

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Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

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National Hospital Organization Kure Medical Center

Kure, Hiroshima, Japan

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Miyoshi Central Hospital

Miyoshi, Hiroshima, Japan

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Asahikawa Medical College

Asahikawa, Hokkaido, Japan

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Otaru Ekisaikai Hospital

Asahikawa, Hokkaido, Japan

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Hakodate Goryoukaku Hospital

Hakodate, Hokkaido, Japan

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Hirosaki University, School of Medicine

Otaru-shi, Hokkaido, Japan

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Sapporo-Kosei General Hospital

Sapporo, Hokkaido, Japan

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Sapporo Medical University

Sapporo, Hokkaido, Japan

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Sapporo City General Hospital

Sapporo, Hokkaido, Japan

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Hokkaido University Graduate School of Medicine

Sapporo, Hokkaido, Japan

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Akashi Municipal Hospital

Akashi, Hyōgo, Japan

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Hyogo Cancer Center

Akashi, Hyōgo, Japan

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Ako City Hospital

Akou, Hyōgo, Japan

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Hyogo Prefectural Amagasaki Hospital

Amagasaki, Hyōgo, Japan

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Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

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Himeji St. Mary's Hospital

Himeji, Hyōgo, Japan

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Himeji Central Hospital

Himeji, Hyōgo, Japan

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Kinki Central Hospital

Itami, Hyōgo, Japan

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Kakogawa Municipal Hospital

Kakogawa, Hyōgo, Japan

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Kobe University Hospital

Kobe, Hyōgo, Japan

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Kobe City General Hospital

Kobe, Hyōgo, Japan

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Shakai Hoken Kobe Central Hospital

Kobe, Hyōgo, Japan

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Nishi-Kobe Medical Center

Kobe, Hyōgo, Japan

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Kobe West City Hospital

Kobe, Hyōgo, Japan

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Kobe Medical Center

Kobe, Hyōgo, Japan

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Sano Hospital

Kobe, Hyōgo, Japan

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Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

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Hyogo Prefectural Awaji Hospital

Sumoto, Hyōgo, Japan

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Takarazuka Municipal Hospital

Takarazuka, Hyōgo, Japan

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Higashi Takarazuka Satoh Hospital

Takarazukai, Hyōgo, Japan

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Public Shiso General Hospital

Yamsakicho, Hyōgo, Japan

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National Hospital Organization Mito Medical Center

Ibaraki, Ibaraki, Japan

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Mito Saiseikai General Hospital

Mito, Ibaraki, Japan

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Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, Japan

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Kanazawa Medical University

Kahoku-gun, Ishikawa-ken, Japan

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Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

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Iwate Medical University Hospital

Morioka, Iwate, Japan

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Iwate Prefectural Central Hospital

Morioka, Iwate, Japan

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Kagawa University Hospital

Hiragi, Kagawa-ken, Japan

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Kagawa Rosai Hospital

Marugame, Kagawa-ken, Japan

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Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan

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Nanpuh Hospital

Kagoshima, Kagoshima-ken, Japan

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Kanagawa Prefectural Ashigawa-kami Hospital

Ashigarakami-gun, Kanagawa, Japan

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Chigasaki Municipal Hospital

Chigasaki, Kanagawa, Japan

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Fujisawa City Hospital

Fujisawa-shi, Kanagawa, Japan

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Kitasato University School of Medicine

Kanagawa, Kanagawa, Japan

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Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

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Nippon Medical School Musashikosugi Hospital

Kawasaki, Kanagawa, Japan

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Saint Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

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Sagamihara National Hospital

Sagamihara, Kanagawa, Japan

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Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, Japan

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Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

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Social Insurance Yokohama Central Hospital

Yokohama, Kanagawa, Japan

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Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

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Saiseikai Yokohama City Nanbu Hospital

Yokohama, Kanagawa, Japan

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Yokohama City Hospital

Yokohama, Kanagawa, Japan

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St. Marianna University Yokohama City Seibu Hospital

Yokohama, Kanagawa, Japan

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Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

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International Goodwill Hospital

Yokohama, Kanagawa, Japan

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Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

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Kochi Health Sciences Center

Kochi, Kochi, Japan

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Kochi Medical School

Nankoku, Kochi, Japan

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Kumamoto University Faculty of Medical and Pharmaceutical Sciences

Kumamoto, Kumamoto, Japan

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Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

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National Hospital Organization - Kumamotominami Hospital

Uki, Kumamoto, Japan

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Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital

Yashiro, Kumamoto, Japan

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Yatsushiro Health Insurance General Hospital

Yatsushiro, Kumamoto, Japan

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Kyoto First Red Cross Hospital

Higashiyama-ku, Kyoto, Japan

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Kyoto Second Red Cross Hospital

Kanigyou-ku, Kyoto, Japan

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Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

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Nishijin Hospital

Kyoto, Kyoto, Japan

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National Hospital Organization - Kyoto Medical Center

Kyoto, Kyoto, Japan

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Kyoto-Katsura Hospital

Kyoto, Kyoto, Japan

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Nantan General Hospital

Nantan, Kyoto, Japan

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Kyoto University Hospital

Sakyo-ku, Kyoto, Japan

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Mie University Graduate School of Medicine

Thu-shi, Mie-ken, Japan

Site Status

Miyagi Cancer Center

Natori-shi, Miyagi, Japan

Site Status

Sendai Kousei Hospital

Sendai, Miyagi, Japan

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Tohoku University Graduate School of Medicine

Sendai, Miyagi, Japan

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Tohoku Rosai Hospital

Sendai, Miyagi, Japan

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Sendai Medical Center

Sendai, Miyagi, Japan

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Iida Municipal Hospital

Iida, Nagano, Japan

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Showa-Inan General Hospital

Komagane, Nagano, Japan

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Aizawa Hospital

Matsumoto, Nagano, Japan

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Nagano Municipal Hospital

Nagano, Nagano, Japan

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Hokushin Hospital

Nakano, Nagano, Japan

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Nagasaki University Hospital

Magasaki-shi, Nagasaki, Japan

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Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Nagasaki, Japan

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National Hospital Organization Nagasaki Medical Center

Ōmura, Nagasaki, Japan

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Sasebo City General Hospital

Sasebo-shi, Nagasaki, Japan

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Nara Medical University Cancer Center

Kashihara, Nara, Japan

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Saiseikai Nara Hospital

Nara, Nara, Japan

Site Status

Kenseikai Nara Coloproctology Center

Yamatotakada, Nara, Japan

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Nagaoka Chuo General Hospital

Nagaoka, Niigata, Japan

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Saiseikai Niigata Daini Hospital

Niigata, Niigata, Japan

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Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

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Niigata Cancer Center Hospital

Niigata, Niigata, Japan

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Oita University Hospital

Yufu-shi, Oita Prefecture, Japan

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Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

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Kawasaki Medical School

Kurashiki-shi, Okayama-ken, Japan

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Okayama University Medical School

Okayama, Okayama-ken, Japan

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Nakagami Hospital

Okinawa, Okinawa, Japan

Site Status

Hoshigaoka Koseinenkin Hospital

Hirakata, Osaka, Japan

Site Status

Izumiotsu Municipal Hospital

Izumiōtsu, Osaka, Japan

Site Status

Rinku General Medical Center

Izumisano, Osaka, Japan

Site Status

Minoh City Hospital

Mino, Osaka, Japan

Site Status

Kansai Medical University Takii Hospital

Moriguchi, Osaka, Japan

Site Status

Kitano Hospital

Osaka, Osaka, Japan

Site Status

Osaka City Juso Hospital

Osaka, Osaka, Japan

Site Status

Osaka City General Hospital

Osaka, Osaka, Japan

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Osaka Saiseikai Noe Hospital

Osaka, Osaka, Japan

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Otemae Hospital

Osaka, Osaka, Japan

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Osaka Police Hospital

Osaka, Osaka, Japan

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Higashi Sumiyoshi Morimoto Hospital

Osaka, Osaka, Japan

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Nissay Hospital

Osaka, Osaka, Japan

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Osaka Kosei Nenkin Hospital

Osaka, Osaka, Japan

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Osaka General Medical Center

Osaka, Osaka, Japan

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Minamiosaka Hospital

Osaka, Osaka, Japan

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Sakai Municipal Hospital

Sakai, Osaka, Japan

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Bell Land General Hospital

Sakai, Osaka, Japan

Site Status

Osaka Rosai Hospital

Sakai-shi, Osaka, Japan

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Kinki University School of Medicine

Sayama, Osaka, Japan

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Suita Municipal Hospital

Suita-shi, Osaka, Japan

Site Status

Osaka Medical College

Takatsuki, Osaka, Japan

Site Status

Saiseikai Tondabayashi Hospital

Tondabayashi, Osaka, Japan

Site Status

Saga Prefectural Hospital Koseikan

Saga, Saga-ken, Japan

Site Status

Fukaya Red Cross Hospital

Fukaya, Saitama, Japan

Site Status

Hasuda Hospital

Hasuda, Saitama, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

Saitama Medical School Hospital

Kawagoe-shi, Saitama, Japan

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Kitasato Institute Medical Center Hospital

Kitamoto, Saitama, Japan

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Saitama Social Insurance Hospital

Saitama, Saitama, Japan

Site Status

Omiya Medical Center ofJichi Medical School

Saitamaken, Saitama, Japan

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National Hospital Organization - Nishisaitama-Chuo National Hospital

Tokorozawa, Saitama, Japan

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National Defense Medical College

Tokorozawa, Saitama, Japan

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Otsu Municipal Hospital

Ōtsu, Shiga, Japan

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Shiga University of Medical Science

Ōtsu, Shiga, Japan

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Shimane Prefectural Central Hospital

Izumo-shi, Shimane, Japan

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Fujieda Municipal General Hospital

Fujieda, Shizuoka, Japan

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Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan

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Shizuoka City Hospital

Shizuoka, Shizuoka, Japan

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Shizuoka Municipal Shimizu Hospital

Shizuoka, Shizuoka, Japan

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Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

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Yaizu Municipal Hospital

Yaizu, Shizuoka, Japan

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Ohtawara Red Cross Hospital

Ohtawawa, Tochigi, Japan

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Dokkyo University School of Medicine

Shimotsuga-gun, Tochigi, Japan

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Jichi Medical School

Shimotsuke-shi, Tochigi, Japan

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Tochigi Cancer Center

Utsunomiya, Tochigi, Japan

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Anan Kyoei Hospital

Anan, Tokushima, Japan

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Tokushima University Hospital

Tokushima, Tokushima, Japan

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Juntendo University School of Medicine

Bunkyo-ku, Tokyo, Japan

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St. Luke's International Hospital

Chuo-ku, Tokyo, Japan

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Tokyo Metropolitan Fuchu Hospital

Fuchū, Tokyo, Japan

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Higashiyamato General Hospital

Higashiyamato, Tokyo, Japan

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Tokyo-Kita Social Insurance Hospital

Kita-ku, Tokyo, Japan

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Showa General Hospital

Kodaira, Tokyo, Japan

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Daisan Hospital

Komae, Tokyo, Japan

Site Status

Toho University Ohashi Hospital

Meguro-ku, Tokyo, Japan

Site Status

Toranomon Hospital

Minato-ku, Tokyo, Japan

Site Status

Kyorin University School of Medicine - Mitaka Campus

Mitaka, Tokyo, Japan

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Nakano General Hospital

Nakano City, Tokyo, Japan

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Social Insurance Chuo General Hospital

Shinjuku-ku, Tokyo, Japan

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Tokyo Women's Medical University

Shinjyuku-ku, Tokyo, Japan

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Mita Hospital at the International University of Health and Welfare

Tokyo, Tokyo, Japan

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Tokyo Medical and Dental University

Tokyo, Tokyo, Japan

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Nippon Medical School

Tokyo, Tokyo, Japan

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Tokyo Metropolitan - Komagome Hospital

Tokyo, Tokyo, Japan

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Tokyo Women's Medical University Medical Center East

Tokyo, Tokyo, Japan

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Metropolitan Bokutoh Hospital

Tokyo, Tokyo, Japan

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Showa University Toyosu Hospital

Tokyo, Tokyo, Japan

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NTT Kanto Medical Center

Tokyo, Tokyo, Japan

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Toho University School of Medicine

Tokyo, Tokyo, Japan

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Japanese Red Cross Medical Center

Tokyo, Tokyo, Japan

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National Hospital Organization - Tokyo Medical Center

Tokyo, Tokyo, Japan

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International Medical Center of Japan

Tokyo, Tokyo, Japan

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Teikyo University School of Medicine

Tokyo, Tokyo, Japan

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Jikei University School of Medicine Hospital

Tokyo, Tokyo, Japan

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Takasago Kyoritsu Hospital

Tokyo, Tokyo, Japan

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Tottori University - Faculty of Medicine

Yonago, Tottori, Japan

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Koseiren Takaoka Hospital

Takaoka-shi, Toyama, Japan

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Toyama Red Cross Hospital

Toyama, Toyama, Japan

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Toyama Prefectural Central Hospital

Toyama, Toyama, Japan

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Shingu Municipal Medical Center

Shingū, Wakayama, Japan

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Social Insurance Kinan Hospital

Tanabe, Wakayama, Japan

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Japan Labor Health and Welfare Organization Wakayama Rosai Hospital

Wakayama, Wakayama, Japan

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Wakayama Medical University

Wakayama, Wakayama, Japan

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Yamagata Prefectural Central Hospital

Yamagata, Yamagata, Japan

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Yamagata Saisei Hospital

Yamagata, Yamagata, Japan

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Yamagata University Hospital

Yamagata, Yamagata, Japan

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National Hospital Organization - Kanmon Medical Center

Shimonoseki, Yamaguchi, Japan

Site Status

Shimonoseki Kosei Hospital

Shimonoseki, Yamaguchi, Japan

Site Status

Yamaguchi University Graduate School of Medicine

Ube, Yamaguchi, Japan

Site Status

University of Yamanashi Faculty of Medicine

Chu-o-shi, Yamanashi, Japan

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Ageo Central General Hospital

Ageo, , Japan

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Saiseikai Hiroshima Hospital

Aki-Gun, , Japan

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Northern Fukushima Medical Center

Date, , Japan

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Chugoku Electric Power Hospital

Hiroshima, , Japan

Site Status

Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital

Hiroshima, , Japan

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Hokkaido Chuo Rosai Hospital

Iwamizawa, , Japan

Site Status

Osaka Minami Medical Center

Kawachi-Nagano, , Japan

Site Status

Kiryu Kosei General Hospital

Kiryū, , Japan

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Kobe Ekisaikai Hospital

Kobe, , Japan

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Konan Kosei Hospital

Kōnan, , Japan

Site Status

Southern TOHOKU research Institute for Neuroscience

Kōriyama, , Japan

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Saiseikai Matsusaka General Hospital

Matsusaka, , Japan

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Muroran City General Hospital

Muroran, , Japan

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Kyoritsu General Hospital

Nagoya, , Japan

Site Status

Nakatsu Municipal Hospital

Nakatsu, , Japan

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Nara Prefectual Nara Hospital

Nara, , Japan

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Numazu City Hospital

Numazu, Shizuoka, , Japan

Site Status

Yodogawa Christian Hospital

Osaka, , Japan

Site Status

Osaka Red Cross Hospital

Osaka, , Japan

Site Status

NTT West Osaka Hospital

Osaka, , Japan

Site Status

Oita Red Cross Hospital

Ōita, , Japan

Site Status

Almeida Memorial Hospital

Ōita, , Japan

Site Status

Oita Prefectural Hospital

Ōita, , Japan

Site Status

Hakodate Municipal Hospital

Sendai, , Japan

Site Status

Miyagi Social Insurance Hospital

Sendai, , Japan

Site Status

Japanese Red Cross Sendai Hospital

Sendai, , Japan

Site Status

Kawakita General Hospital

Suginami-ku, , Japan

Site Status

Niigata Prefectural Tokamachi Hospital

Tōkamachi, , Japan

Site Status

Japanese Red Cross Society

Wakayama, , Japan

Site Status

Saiseikai Yokohamashi Tobu Hospital

Yokohama, , Japan

Site Status

Yokohama City Minato Red Cross Hospital

Yokohama, , Japan

Site Status

Hitachi Yokohama Hospital

Yokohama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 31180819 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29677641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22769569 (View on PubMed)

Other Identifiers

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TMDU-BRI-CC-05-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000512573

Identifier Type: -

Identifier Source: org_study_id

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