Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
2 other identifiers
interventional
2,025
1 country
272
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Oct 2006
Longer than P75 for phase_3 colorectal-cancer
272 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 25, 2006
CompletedFirst Posted
Study publicly available on registry
October 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 28, 2016
July 1, 2009
9 years
October 25, 2006
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
Disease-free survival is defined as the time from date of enrollement until date of recurrence, other malignancies or death from any cause, whichever comes first.
9 years
Secondary Outcomes (2)
Overall survival
9 years
Types and severities of adverse events
15 months
Study Arms (2)
UFT adjuvant therapy group
ACTIVE COMPARATORUFT 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.
Observation group
NO INTERVENTIONPatients 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.
Interventions
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (272)
Aichi Medical University
Aichi-gun, Aichi-ken, 480-1100, Japan
Japanese Red Cross Nagoya First Hospital
Nagoya, Aichi-ken, 453-0046, Japan
Nagoya Central Hospital
Nagoya, Aichi-ken, 453-0801, Japan
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, 454-8502, Japan
Ban Buntane Houtokukai Hospital
Nagoya, Aichi-ken, 454-8509, Japan
West Medical Center Jouhoku Municipal Hospital
Nagoya, Aichi-ken, 462-0033, Japan
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550, Japan
Nagoya University School of Medicine
Nagoya, Aichi-ken, 466, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Nagoya Midori Municipal Hospital
Nagoya, Aichi-ken, Japan
Aichi Cancer Center at Aichi Hospital
Okazaki, Aichi-ken, 444-0011, Japan
National Hospital Organization Toyohashi Medical Center
Toyohashi, Aichi-ken, 440-0836, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Koseiren Kamo Hospital
Toyota, Aichi-ken, 471-8505, Japan
Akita Kumiai General Hospital
Akita, Akita, 011-0948, Japan
Yamamoto Kumiai General Hospital
Noshiro, Akita, 016-0014, Japan
Hiraka General Hospital
Yokote, Akita, 013-8610, Japan
Aomori City Hospital
Aomori, Aomori, 030-0821, Japan
Asahi General Hospital
Asahi-machi, Chiba, 289-2511, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Chiba University
Chiba, Chiba, 260, Japan
Teikyo University Chiba Medical Center
Ichihara, Chiba, 299-0111, Japan
Juntendo Urayasu Hospital
Urayasu-shi, Chiba, 279-0021, Japan
Shikoku Cancer Center
Matsuyama, Ehime, 790-0007, Japan
Sumitomo Besshi Hospital
Niihama, Ehime, 792-0008, Japan
Fukuiken Saiseikai Hospital
Fukui-shi, Fukui, 918-8503, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-0065, Japan
National Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kitakyushu Municipal Medical Center
Kitakyushu, Fukuoka, 802-0077, Japan
University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, 807-8555, Japan
Kurume University School of Medicine
Kurume, Fukuoka, 830-0011, Japan
Saint Mary's Hospital
Kurume, Fukuoka, 830-8543, Japan
Social Insurance Tagawa Hospital
Tagawa, Fukuoka, 826-8585, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8323, Japan
Matsunami General Hospital
Gifu, Gifu, 501-6062, Japan
Hashima City Hospital
Hashima, Gifu, 501-6206, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, 503-8502, Japan
Gunma University Graduate School of Medicine
Maebashi, Gunma, 371-8511, Japan
Gunma Cancer Center
Otashi, Gunma, 373-8550, Japan
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima, 720-0825, Japan
Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuyama, Hiroshima, 721-8581, Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, 737-0023, Japan
Miyoshi Central Hospital
Miyoshi, Hiroshima, 728-8502, Japan
Asahikawa Medical College
Asahikawa, Hokkaido, 078-8510, Japan
Otaru Ekisaikai Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Hakodate Goryoukaku Hospital
Hakodate, Hokkaido, 040-8611, Japan
Hirosaki University, School of Medicine
Otaru-shi, Hokkaido, 047-0031, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060-0033, Japan
Sapporo Medical University
Sapporo, Hokkaido, 060-8556, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, 060-8604, Japan
Hokkaido University Graduate School of Medicine
Sapporo, Hokkaido, 060-8638, Japan
Akashi Municipal Hospital
Akashi, Hyōgo, 673-8501, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Ako City Hospital
Akou, Hyōgo, 678-0232, Japan
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo, 660-0828, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511, Japan
Himeji St. Mary's Hospital
Himeji, Hyōgo, 670-0801, Japan
Himeji Central Hospital
Himeji, Hyōgo, 672-8501, Japan
Kinki Central Hospital
Itami, Hyōgo, Japan
Kakogawa Municipal Hospital
Kakogawa, Hyōgo, 675-8611, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kobe City General Hospital
Kobe, Hyōgo, 650-0046, Japan
Shakai Hoken Kobe Central Hospital
Kobe, Hyōgo, 651-1145, Japan
Nishi-Kobe Medical Center
Kobe, Hyōgo, 651-2273, Japan
Kobe West City Hospital
Kobe, Hyōgo, 653-0013, Japan
Kobe Medical Center
Kobe, Hyōgo, 654-0155, Japan
Sano Hospital
Kobe, Hyōgo, 655-0031, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, 656-0013, Japan
Takarazuka Municipal Hospital
Takarazuka, Hyōgo, 665-0827, Japan
Higashi Takarazuka Satoh Hospital
Takarazukai, Hyōgo, 665-0873, Japan
Public Shiso General Hospital
Yamsakicho, Hyōgo, Japan
National Hospital Organization Mito Medical Center
Ibaraki, Ibaraki, 311-3193, Japan
Mito Saiseikai General Hospital
Mito, Ibaraki, 311-4198, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, 300-0053, Japan
Kanazawa Medical University
Kahoku-gun, Ishikawa-ken, 920-0265, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-8505, Japan
Kagawa University Hospital
Hiragi, Kagawa-ken, 761-0793, Japan
Kagawa Rosai Hospital
Marugame, Kagawa-ken, 763-8502, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Nanpuh Hospital
Kagoshima, Kagoshima-ken, 892-8512, Japan
Kanagawa Prefectural Ashigawa-kami Hospital
Ashigarakami-gun, Kanagawa, 258-0003, Japan
Chigasaki Municipal Hospital
Chigasaki, Kanagawa, 253-0083, Japan
Fujisawa City Hospital
Fujisawa-shi, Kanagawa, 251-8550, Japan
Kitasato University School of Medicine
Kanagawa, Kanagawa, 228-8555, Japan
Kanto Rosai Hospital
Kawasaki, Kanagawa, 211-8510, Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki, Kanagawa, 211-8533, Japan
Saint Marianna University School of Medicine
Kawasaki, Kanagawa, 216-8511, Japan
Sagamihara National Hospital
Sagamihara, Kanagawa, 228-8522, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8502, Japan
Social Insurance Yokohama Central Hospital
Yokohama, Kanagawa, 231-8553, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Saiseikai Yokohama City Nanbu Hospital
Yokohama, Kanagawa, 234-8503, Japan
Yokohama City Hospital
Yokohama, Kanagawa, 240, Japan
St. Marianna University Yokohama City Seibu Hospital
Yokohama, Kanagawa, 241-0811, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-0815, Japan
International Goodwill Hospital
Yokohama, Kanagawa, 245-0006, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, 238-8558, Japan
Kochi Health Sciences Center
Kochi, Kochi, 781-8555, Japan
Kochi Medical School
Nankoku, Kochi, 783-8505, Japan
Kumamoto University Faculty of Medical and Pharmaceutical Sciences
Kumamoto, Kumamoto, 860-8556, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
National Hospital Organization - Kumamotominami Hospital
Uki, Kumamoto, 869-0, Japan
Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
Yashiro, Kumamoto, 866-0826, Japan
Yatsushiro Health Insurance General Hospital
Yatsushiro, Kumamoto, 866-8660, Japan
Kyoto First Red Cross Hospital
Higashiyama-ku, Kyoto, 605-0981, Japan
Kyoto Second Red Cross Hospital
Kanigyou-ku, Kyoto, 602-8026, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-0841, Japan
Nishijin Hospital
Kyoto, Kyoto, 602, Japan
National Hospital Organization - Kyoto Medical Center
Kyoto, Kyoto, 612-0861, Japan
Kyoto-Katsura Hospital
Kyoto, Kyoto, 615-8256, Japan
Nantan General Hospital
Nantan, Kyoto, 629-0197, Japan
Kyoto University Hospital
Sakyo-ku, Kyoto, 606-8507, Japan
Mie University Graduate School of Medicine
Thu-shi, Mie-ken, 514-8507, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, 981-1293, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Tohoku University Graduate School of Medicine
Sendai, Miyagi, 980-8574, Japan
Tohoku Rosai Hospital
Sendai, Miyagi, 981-0911, Japan
Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
Iida Municipal Hospital
Iida, Nagano, 395-8502, Japan
Showa-Inan General Hospital
Komagane, Nagano, 399-4191, Japan
Aizawa Hospital
Matsumoto, Nagano, 390-8510, Japan
Nagano Municipal Hospital
Nagano, Nagano, 381-8551, Japan
Hokushin Hospital
Nakano, Nagano, 383-0021, Japan
Nagasaki University Hospital
Magasaki-shi, Nagasaki, 852-8501, Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, Nagasaki, 852-8511, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 856-8562, Japan
Sasebo City General Hospital
Sasebo-shi, Nagasaki, 857-8511, Japan
Nara Medical University Cancer Center
Kashihara, Nara, 634-8522, Japan
Saiseikai Nara Hospital
Nara, Nara, 6308145, Japan
Kenseikai Nara Coloproctology Center
Yamatotakada, Nara, 635-0022, Japan
Nagaoka Chuo General Hospital
Nagaoka, Niigata, 940-8653, Japan
Saiseikai Niigata Daini Hospital
Niigata, Niigata, 950-1104, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8122, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, 879-5593, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602, Japan
Kawasaki Medical School
Kurashiki-shi, Okayama-ken, 701-0192, Japan
Okayama University Medical School
Okayama, Okayama-ken, 700-8558, Japan
Nakagami Hospital
Okinawa, Okinawa, 904-2195, Japan
Hoshigaoka Koseinenkin Hospital
Hirakata, Osaka, 573-8511, Japan
Izumiotsu Municipal Hospital
Izumiōtsu, Osaka, 595, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-8577, Japan
Minoh City Hospital
Mino, Osaka, 562-0014, Japan
Kansai Medical University Takii Hospital
Moriguchi, Osaka, 570-8507, Japan
Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Osaka City Juso Hospital
Osaka, Osaka, 532-0, Japan
Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
Osaka Saiseikai Noe Hospital
Osaka, Osaka, 536-0002, Japan
Otemae Hospital
Osaka, Osaka, 540-0008, Japan
Osaka Police Hospital
Osaka, Osaka, 543-8502, Japan
Higashi Sumiyoshi Morimoto Hospital
Osaka, Osaka, 546-0012, Japan
Nissay Hospital
Osaka, Osaka, 550-0012, Japan
Osaka Kosei Nenkin Hospital
Osaka, Osaka, 553-0003, Japan
Osaka General Medical Center
Osaka, Osaka, 558-8558, Japan
Minamiosaka Hospital
Osaka, Osaka, Japan
Sakai Municipal Hospital
Sakai, Osaka, 590-0064, Japan
Bell Land General Hospital
Sakai, Osaka, 599-8247, Japan
Osaka Rosai Hospital
Sakai-shi, Osaka, 591-8025, Japan
Kinki University School of Medicine
Sayama, Osaka, 589-8511, Japan
Suita Municipal Hospital
Suita-shi, Osaka, 564-0082, Japan
Osaka Medical College
Takatsuki, Osaka, 569-8686, Japan
Saiseikai Tondabayashi Hospital
Tondabayashi, Osaka, 584-0082, Japan
Saga Prefectural Hospital Koseikan
Saga, Saga-ken, 840-8571, Japan
Fukaya Red Cross Hospital
Fukaya, Saitama, 366-0052, Japan
Hasuda Hospital
Hasuda, Saitama, 349-0123, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1241, Japan
Saitama Medical School Hospital
Kawagoe-shi, Saitama, 350-8550, Japan
Kitasato Institute Medical Center Hospital
Kitamoto, Saitama, 3648501, Japan
Saitama Social Insurance Hospital
Saitama, Saitama, 330-0074, Japan
Omiya Medical Center ofJichi Medical School
Saitamaken, Saitama, 330-8503, Japan
National Hospital Organization - Nishisaitama-Chuo National Hospital
Tokorozawa, Saitama, 359-1151, Japan
National Defense Medical College
Tokorozawa, Saitama, 359-8513, Japan
Otsu Municipal Hospital
Ōtsu, Shiga, 520-0804, Japan
Shiga University of Medical Science
Ōtsu, Shiga, 520-2192, Japan
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, 693-0068, Japan
Fujieda Municipal General Hospital
Fujieda, Shizuoka, 426-8677, Japan
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192, Japan
Shizuoka City Hospital
Shizuoka, Shizuoka, 420 -8630, Japan
Shizuoka Municipal Shimizu Hospital
Shizuoka, Shizuoka, 424-0911, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Yaizu Municipal Hospital
Yaizu, Shizuoka, 425-8505, Japan
Ohtawara Red Cross Hospital
Ohtawawa, Tochigi, 324-0, Japan
Dokkyo University School of Medicine
Shimotsuga-gun, Tochigi, 321-0293, Japan
Jichi Medical School
Shimotsuke-shi, Tochigi, 329-0498, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
Anan Kyoei Hospital
Anan, Tokushima, 770-8503, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Juntendo University School of Medicine
Bunkyo-ku, Tokyo, 113-0033, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560, Japan
Tokyo Metropolitan Fuchu Hospital
Fuchū, Tokyo, 183-8524, Japan
Higashiyamato General Hospital
Higashiyamato, Tokyo, 207-0014, Japan
Tokyo-Kita Social Insurance Hospital
Kita-ku, Tokyo, 115-0053, Japan
Showa General Hospital
Kodaira, Tokyo, 187-8510, Japan
Daisan Hospital
Komae, Tokyo, 201, Japan
Toho University Ohashi Hospital
Meguro-ku, Tokyo, 153-8515, Japan
Toranomon Hospital
Minato-ku, Tokyo, 105-8470, Japan
Kyorin University School of Medicine - Mitaka Campus
Mitaka, Tokyo, 181-8611, Japan
Nakano General Hospital
Nakano City, Tokyo, 164-8607, Japan
Social Insurance Chuo General Hospital
Shinjuku-ku, Tokyo, 169-0073, Japan
Tokyo Women's Medical University
Shinjyuku-ku, Tokyo, 162-8666, Japan
Mita Hospital at the International University of Health and Welfare
Tokyo, Tokyo, 108-8329, Japan
Tokyo Medical and Dental University
Tokyo, Tokyo, 113-8519, Japan
Nippon Medical School
Tokyo, Tokyo, 113-8603, Japan
Tokyo Metropolitan - Komagome Hospital
Tokyo, Tokyo, 113-8677, Japan
Tokyo Women's Medical University Medical Center East
Tokyo, Tokyo, 116-8567, Japan
Metropolitan Bokutoh Hospital
Tokyo, Tokyo, 130-8575, Japan
Showa University Toyosu Hospital
Tokyo, Tokyo, 135-8577, Japan
NTT Kanto Medical Center
Tokyo, Tokyo, 141-8625, Japan
Toho University School of Medicine
Tokyo, Tokyo, 143-8541, Japan
Japanese Red Cross Medical Center
Tokyo, Tokyo, 150-8935, Japan
National Hospital Organization - Tokyo Medical Center
Tokyo, Tokyo, 152-0021, Japan
International Medical Center of Japan
Tokyo, Tokyo, 162-8655, Japan
Teikyo University School of Medicine
Tokyo, Tokyo, 173-8605, Japan
Jikei University School of Medicine Hospital
Tokyo, Tokyo, 25-8506, Japan
Takasago Kyoritsu Hospital
Tokyo, Tokyo, Japan
Tottori University - Faculty of Medicine
Yonago, Tottori, 683-8503, Japan
Koseiren Takaoka Hospital
Takaoka-shi, Toyama, 933-8555, Japan
Toyama Red Cross Hospital
Toyama, Toyama, 930-0859, Japan
Toyama Prefectural Central Hospital
Toyama, Toyama, 930-8550, Japan
Shingu Municipal Medical Center
Shingū, Wakayama, 647-0072, Japan
Social Insurance Kinan Hospital
Tanabe, Wakayama, 646-8588, Japan
Japan Labor Health and Welfare Organization Wakayama Rosai Hospital
Wakayama, Wakayama, 640-8435, Japan
Wakayama Medical University
Wakayama, Wakayama, 641-8509, Japan
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, 990-2292, Japan
Yamagata Saisei Hospital
Yamagata, Yamagata, 990-8545, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
National Hospital Organization - Kanmon Medical Center
Shimonoseki, Yamaguchi, 240-8555, Japan
Shimonoseki Kosei Hospital
Shimonoseki, Yamaguchi, 750-0061, Japan
Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, 755-8505, Japan
University of Yamanashi Faculty of Medicine
Chu-o-shi, Yamanashi, 409-3898, Japan
Ageo Central General Hospital
Ageo, 362-8588, Japan
Saiseikai Hiroshima Hospital
Aki-Gun, 731-4311, Japan
Northern Fukushima Medical Center
Date, 960-0502, Japan
Chugoku Electric Power Hospital
Hiroshima, 730-8562, Japan
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
Hokkaido Chuo Rosai Hospital
Iwamizawa, 068-0004, Japan
Osaka Minami Medical Center
Kawachi-Nagano, 586-8521, Japan
Kiryu Kosei General Hospital
Kiryū, 376-0024, Japan
Kobe Ekisaikai Hospital
Kobe, 655-0004, Japan
Konan Kosei Hospital
Kōnan, 483-8704, Japan
Southern TOHOKU research Institute for Neuroscience
Kōriyama, 963-8563, Japan
Saiseikai Matsusaka General Hospital
Matsusaka, 515-0004, Japan
Muroran City General Hospital
Muroran, 051-8512, Japan
Kyoritsu General Hospital
Nagoya, 456-8611, Japan
Nakatsu Municipal Hospital
Nakatsu, 871-0011, Japan
Nara Prefectual Nara Hospital
Nara, 631-0846, Japan
Numazu City Hospital
Numazu, Shizuoka, 410-0302, Japan
Yodogawa Christian Hospital
Osaka, 533-0032, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
NTT West Osaka Hospital
Osaka, 543-8922, Japan
Oita Red Cross Hospital
Ōita, 870-0033, Japan
Almeida Memorial Hospital
Ōita, 870-1195, Japan
Oita Prefectural Hospital
Ōita, 870-8511, Japan
Hakodate Municipal Hospital
Sendai, 981-1103, Japan
Miyagi Social Insurance Hospital
Sendai, 981-1103, Japan
Japanese Red Cross Sendai Hospital
Sendai, 982-8501, Japan
Kawakita General Hospital
Suginami-ku, 166-8588, Japan
Niigata Prefectural Tokamachi Hospital
Tōkamachi, 948-0055, Japan
Japanese Red Cross Society
Wakayama, 640-8269, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 230-0012, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, 231-8682, Japan
Hitachi Yokohama Hospital
Yokohama, 244-0003, Japan
Related Publications (3)
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.
PMID: 31180819DERIVEDMatsuda 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.
PMID: 29677641DERIVEDIshiguro 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.
PMID: 22769569DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kenichi Sugihara, MD, PhD
Tokyo Medical and Dental University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2006
First Posted
October 26, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2015
Study Completion
September 1, 2016
Last Updated
September 28, 2016
Record last verified: 2009-07