Tegafur-Uracil eller observation ved behandling af patienter med trin II kolorektal cancer, der er blevet fuldstændigt fjernet ved kirurgi
26. september 2016 opdateret af: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Randomiseret fase III-forsøg med adjuverende kemoterapi med UFT vs. observation i kurativt resekeret stadium II tyktarmskræft
RATIONALE: Lægemidler, der bruges i kemoterapi, såsom tegafur-uracil, virker på forskellige måder for at stoppe væksten af tumorceller, enten ved at dræbe cellerne eller ved at stoppe dem i at dele sig. At give kemoterapi efter operationen kan dræbe eventuelle tumorceller, der er tilbage efter operationen. Nogle gange, efter operationen, behøver tumoren muligvis ikke mere behandling, før den skrider frem. I dette tilfælde kan observation være tilstrækkelig. Det vides endnu ikke, om kemoterapi er mere effektiv end observation til behandling af kolorektal cancer.
FORMÅL: Dette randomiserede fase III-forsøg studerer tegafur og uracil for at se, hvor godt de virker sammenlignet med observation ved behandling af patienter med stadium II kolorektal cancer, som er blevet fuldstændig fjernet ved operation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
Primær
- Sammenlign effektiviteten af adjuverende tegafur-uracil vs kun observation hos patienter med kurativt resekeret stadium II kolorektal cancer.
Sekundær
- Sammenlign tilbagefaldsfri og samlet overlevelse af patienter behandlet med disse regimer.
- Sammenlign forekomsten af bivirkninger hos patienter behandlet med disse regimer.
OVERSIGT: Dette er en randomiseret, kontrolleret undersøgelse. Patienterne randomiseres til 1 ud af 2 behandlingsarme.
- Arm I: Patienter gennemgår observation.
- Arm II: Patienterne får oral tegafur-uracil på dag 1-5. Behandlingen gentages hver 7. dag i 1 år i fravær af sygdomsprogression eller uacceptabel toksicitet.
Efter afslutning af studiebehandlingen følges patienterne periodisk i 5 år.
PROJEKTERET TILSLUTNING: I alt 2.000 patienter vil blive akkumuleret til denne undersøgelse.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2025
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Ageo, Japan, 362-8588
- Ageo Central General Hospital
-
Aki-Gun, Japan, 731-4311
- Saiseikai Hiroshima Hospital
-
Akita, Japan, 011-0948
- Akita Kumiai General Hospital
-
Aomori, Japan, 030-0821
- Aomori City Hospital
-
Chiba, Japan, 260-8717
- Chiba Cancer Center
-
Chiba, Japan, 260
- Chiba University
-
Date, Japan, 960-0502
- Northern Fukushima Medical Center
-
Fukuoka, Japan, 811-1395
- National Kyushu Cancer Center
-
Fukuoka, Japan, 810-0065
- National Hospital Organization Kyushu Medical Center
-
Gifu, Japan, 501-6062
- Matsunami General Hospital
-
Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
-
Hiroshima, Japan, 734-8530
- Hiroshima Prefectural Hospital
-
Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
-
Hiroshima-shi, Japan, 730-8562
- Chugoku Electric Power Hospital
-
Ibaraki, Japan, 311-3193
- National Hospital Organization Mito Medical Center
-
Iwamizawa, Japan, 068-0004
- Hokkaido Chuo Rosai Hospital
-
Kagoshima, Japan, 892-8512
- Nanpuh Hospital
-
Kanagawa, Japan, 228-8555
- Kitasato University School of Medicine
-
Kawachinagano, Japan, 586-8521
- Osaka Minami Medical Center
-
Kiryu, Japan, 376-0024
- Kiryu Kosei General Hospital
-
Kobe, Japan, 655-0004
- Kobe Ekisaikai Hospital
-
Kochi, Japan, 781-8555
- Kochi Health Sciences Center
-
Konan, Japan, 483-8704
- Konan Kosei Hospital
-
Koriyama-city, Japan, 963-8563
- Southern Tohoku Research Institute for Neuroscience
-
Kumamoto, Japan, 861-8520
- Japanese Red Cross Kumamoto Hospital
-
Kumamoto, Japan, 860-8556
- Kumamoto University Faculty of Medical and Pharmaceutical Sciences
-
Kyoto, Japan, 615-8256
- Kyoto-Katsura Hospital
-
Kyoto, Japan, 602-0841
- Kyoto Prefectural University of Medicine
-
Kyoto, Japan, 602
- Nishijin Hospital
-
Kyoto, Japan, 612-0861
- National Hospital Organization - Kyoto Medical Center
-
Matsusaka, Japan, 515-0004
- Saiseikai Matsusaka General Hospital
-
Muroran, Japan, 051-8512
- Muroran City General Hospital
-
Nagoya, Japan, 456-8611
- Kyoritsu General Hospital
-
Nakatsu, Japan, 871-0011
- Nakatsu Municipal Hospital
-
Nara, Japan, 6308145
- Saiseikai Nara Hospital
-
Nara, Japan, 631-0846
- Nara Prefectual Nara Hospital
-
Niigata, Japan, 950-1104
- Saiseikai Niigata Daini Hospital
-
Numazu, Shizuoka, Japan, 410-0302
- Numazu City Hospital
-
Oita, Japan, 870-0033
- Oita Red Cross Hospital
-
Oita, Japan, 870-1195
- Almeida Memorial Hospital
-
Oita-shi, Japan, 870-8511
- Oita Prefectural Hospital
-
Okayama, Japan, 700-8558
- Okayama University Medical School
-
Okinawa, Japan, 904-2195
- Nakagami Hospital
-
Osaka, Japan, 543-8555
- Osaka Red Cross Hospital
-
Osaka, Japan, 530-8480
- Kitano Hospital
-
Osaka, Japan, 532-0
- Osaka City Juso Hospital
-
Osaka, Japan, 533-0032
- Yodogawa Christian Hospital
-
Osaka, Japan, 536-0002
- Osaka Saiseikai Noe Hospital
-
Osaka, Japan, 540-0008
- Otemae Hospital
-
Osaka, Japan, 543-8922
- NTT WEST Osaka Hospital
-
Osaka, Japan, 546-0012
- Higashi Sumiyoshi Morimoto Hospital
-
Osaka, Japan, 550-0012
- Nissay Hospital
-
Osaka, Japan
- Minamiosaka Hospital
-
Saga, Japan, 840-8571
- Saga Prefectural Hospital Koseikan
-
Saitama, Japan, 330-0074
- Saitama Social Insurance Hospital
-
Sendai, Japan, 981-1103
- Hakodate Municipal Hospital
-
Sendai, Japan, 981-1103
- Miyagi Social Insurance Hospital
-
Sendai, Japan, 982-8501
- Japanese Red Cross Sendai Hospital
-
Shizuoka, Japan, 420 -8630
- Shizuoka City Hospital
-
Shizuoka, Japan, 424-0911
- Shizuoka Municipal Shimizu Hospital
-
Suginami-ku, Japan, 166-8588
- Kawakita General Hospital
-
Tokamachi, Japan, 948-0055
- Niigata Prefectural Tokamachi Hospital
-
Tokushima, Japan, 770-8503
- Tokushima University Hospital
-
Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University
-
Tokyo, Japan, 162-8655
- International Medical Center of Japan
-
Tokyo, Japan, 116-8567
- Tokyo Women's Medical University Medical Center East
-
Tokyo, Japan, 113-8603
- Nippon Medical School
-
Tokyo, Japan, 108-8329
- Mita Hospital at the International University of Health and Welfare
-
Tokyo, Japan, 113-8677
- Tokyo Metropolitan - Komagome Hospital
-
Tokyo, Japan, 130-8575
- Metropolitan Bokutoh Hospital
-
Tokyo, Japan, 135-8577
- Showa University Toyosu Hospital
-
Tokyo, Japan, 141-8625
- NTT Kanto Medical Center
-
Tokyo, Japan, 143-8541
- Toho University School of Medicine
-
Tokyo, Japan, 150-8935
- Japanese Red Cross Medical Center
-
Tokyo, Japan, 152-0021
- National Hospital Organization - Tokyo Medical Center
-
Tokyo, Japan, 173-8605
- Teikyo University School of Medicine
-
Tokyo, Japan, 25-8506
- Jikei University School of Medicine Hospital
-
Tokyo, Japan
- Takasago Kyoritsu Hospital
-
Toyama, Japan, 930-0859
- Toyama Red Cross Hospital
-
Wakayama, Japan, 640-8269
- Japanese Red Cross Society
-
Wakayama, Japan, 640-8435
- Japan Labor Health and Welfare Organization Wakayama Rosai Hospital
-
Yamagata, Japan, 990-2292
- Yamagata Prefectural Central Hospital
-
Yamagata, Japan, 990-9585
- Yamagata University Hospital
-
Yamagata, Japan, 990-8545
- Yamagata Saisei Hospital
-
Yokohama, Japan, 230-0012
- Saiseikai Yokohamashi Tobu Hospital
-
Yokohama, Japan, 231-8682
- Yokohama City Minato Red Cross Hospital
-
Yokohama, Japan, 244-0003
- Hitachi Yokohama Hospital
-
-
Aichi
-
Aichi-gun, Aichi, Japan, 480-1100
- Aichi Medical University
-
Nagoya, Aichi, Japan, 464-8681
- Aichi Cancer Center
-
Nagoya, Aichi, Japan, 454-8502
- Nagoya Ekisaikai Hospital
-
Nagoya, Aichi, Japan, 453-0801
- Nagoya Central Hospital
-
Nagoya, Aichi, Japan, 454-8509
- Ban Buntane Houtokukai Hospital
-
Nagoya, Aichi, Japan, 462-0033
- West Medical Center Jouhoku Municipal Hospital
-
Nagoya, Aichi, Japan, 466-8550
- Nagoya University Hospital
-
Nagoya, Aichi, Japan, 466
- Nagoya University School of Medicine
-
Nagoya, Aichi, Japan
- Nagoya Midori Municipal Hospital
-
Nagoya-shi, Aichi, Japan, 467-8602
- Nagoya City University Hospital
-
Nagoya-shi, Aichi, Japan, 453-0046
- Japanese Red Cross Nagoya First Hospital
-
Okazaki, Aichi, Japan, 444-0011
- Aichi Cancer Center at Aichi Hospital
-
Toyohashi, Aichi, Japan, 441-8570
- Toyohashi Municipal Hospital
-
Toyohashi, Aichi, Japan, 440-0836
- National Hospital Organization Toyohashi Medical Center
-
Toyota, Aichi, Japan, 471-8505
- Koseiren Kamo Hospital
-
-
Akita
-
Noshiro, Akita, Japan, 016-0014
- Yamamoto Kumiai General Hospital
-
Yokote, Akita, Japan, 013-8610
- Hiraka General Hospital
-
-
Chiba
-
Asahi-machi, Chiba, Japan, 289-2511
- Asahi General Hospital
-
Ichihara, Chiba, Japan, 299-0111
- Teikyo University Chiba Medical Center
-
Urayasu-shi, Chiba, Japan, 279-0021
- Juntendo Urayasu Hospital
-
-
Ehime
-
Matsuyama, Ehime, Japan, 790-0007
- Shikoku Cancer Center
-
Niihama, Ehime, Japan, 792-0008
- Sumitomo Besshi Hospital
-
-
Fukui
-
Fukui-shi, Fukui, Japan, 918-8503
- Fukuiken Saiseikai Hospital
-
Yoshida-gun, Fukui, Japan, 910-1193
- University of Fukui Hospital
-
-
Fukuoka
-
Fukuoka-shi, Fukuoka, Japan, 812-8582
- Kyushu University Hospital
-
Kitakyushu, Fukuoka, Japan, 802-0077
- Kitakyushu Municipal Medical Center
-
Kitakyushu-shi, Fukuoka, Japan, 807-8555
- University of Occupational and Environmental Health
-
Kurume, Fukuoka, Japan, 830-0011
- Kurume University School of Medicine
-
Kurume, Fukuoka, Japan, 830-8543
- Saint Mary's Hospital
-
Tagawa, Fukuoka, Japan, 826-8585
- Social Insurance Tagawa Hospital
-
-
Fukushima
-
Fukushima-shi, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
-
-
Gifu
-
Gifu-shi, Gifu, Japan, 500-8323
- Gifu Municipal Hospital
-
Hashima, Gifu, Japan, 501-6206
- Hashima City Hospital
-
Ogaki-shi, Gifu, Japan, 503-8502
- Ogaki Municipal Hospital
-
-
Gunma
-
Maebashi-shi, Gunma, Japan, 371-8511
- Gunma University Graduate School of Medicine
-
Otashi, Gunma, Japan, 373-8550
- Gunma Cancer Center
-
-
Hiroshima
-
Fukuyama, Hiroshima, Japan, 720-0825
- National Hospital Organization Fukuyama Medical Center
-
Fukuyama, Hiroshima, Japan, 721-8581
- Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers
-
Kure, Hiroshima, Japan, 737-0023
- National Hospital Organization Kure Medical Center
-
Miyoshi, Hiroshima, Japan, 728-8502
- Miyoshi Central Hospital
-
-
Hokkaido
-
Asahikawa, Hokkaido, Japan, 078-8510
- Asahikawa Medical College
-
Asahikawa, Hokkaido, Japan, 078-8510
- Otaru Ekisaikai Hospital
-
Hakodate, Hokkaido, Japan, 040-8611
- Hakodate Goryoukaku Hospital
-
Otaru-shi, Hokkaido, Japan, 047-0031
- Hirosaki University, School of Medicine
-
Sapporo, Hokkaido, Japan, 060-8604
- Sapporo City General Hospital
-
Sapporo, Hokkaido, Japan, 060-8556
- Sapporo Medical University
-
Sapporo, Hokkaido, Japan, 060-8638
- Hokkaido University Graduate School of Medicine
-
Sapporo-shi, Hokkaido, Japan, 060-0033
- Sapporo-Kosei General Hospital
-
-
Hyogo
-
Akashi, Hyogo, Japan, 673-8558
- Hyogo Cancer Center
-
Akashi, Hyogo, Japan, 673-8501
- Akashi Municipal Hospital
-
Akou, Hyogo, Japan, 678-0232
- Ako City Hospital
-
Amagasaki, Hyogo, Japan, 660-8511
- Kansai Rosai Hospital
-
Amagasaki, Hyogo, Japan, 660-0828
- Hyogo Prefectural Amagasaki Hospital
-
Himeji, Hyogo, Japan, 672-8501
- Himeji Central Hospital
-
Himeji, Hyogo, Japan, 670-0801
- Himeji St. Mary's Hospital
-
Itami, Hyogo, Japan
- Kinki Central Hospital
-
Kakogawa, Hyogo, Japan, 675-8611
- Kakogawa Municipal Hospital
-
Kobe, Hyogo, Japan, 650-0017
- Kobe University Hospital
-
Kobe, Hyogo, Japan, 651-1145
- Shakai Hoken Kobe Central Hospital
-
Kobe, Hyogo, Japan, 651-2273
- Nishi-Kobe Medical Center
-
Kobe, Hyogo, Japan, 653-0013
- Kobe West City Hospital
-
Kobe, Hyogo, Japan, 654-0155
- Kobe Medical Center
-
Kobe, Hyogo, Japan, 655-0031
- Sano Hospital
-
Kobe-shi, Hyogo, Japan, 650-0046
- Kobe City General Hospital
-
Nishinomiya, Hyogo, Japan, 663-8501
- Hyogo College of Medicine
-
Sumoto, Hyogo, Japan, 656-0013
- Hyogo Prefectural AWAJI Hospital
-
Takarazuka, Hyogo, Japan, 665-0827
- Takarazuka Municipal Hospital
-
Takarazukai, Hyogo, Japan, 665-0873
- Higashi Takarazuka Satoh Hospital
-
Yamsakicho, Hyogo, Japan
- Public Shiso General Hospital
-
-
Ibaraki
-
Mito, Ibaraki, Japan, 311-4198
- Mito Saiseikai General Hospital
-
Tsuchiura, Ibaraki, Japan, 300-0053
- Tsuchiura Kyodo General Hospital
-
-
Ishikawa
-
Kahoku-gun, Ishikawa, Japan, 920-0265
- Kanazawa Medical University
-
Kanazawa, Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
-
-
Iwate
-
Morioka, Iwate, Japan, 020-8505
- Iwate Medical University Hospital
-
Morioka, Iwate, Japan, 020-8505
- Iwate Prefectural Central Hospital
-
-
Kagawa
-
Marugame, Kagawa, Japan, 763-8502
- Kagawa Rosai Hospital
-
Miki, Kagawa, Japan, 761-0793
- Kagawa University Hospital
-
Takamatsu, Kagawa, Japan, 760-8557
- Kagawa Prefectural Central Hospital
-
-
Kanagawa
-
Ashigarakami-gun, Kanagawa, Japan, 258-0003
- Kanagawa Prefectural Ashigawa-kami Hospital
-
Chigasaki, Kanagawa, Japan, 253-0083
- Chigasaki Municipal Hospital
-
Fujisawa-shi, Kanagawa, Japan, 251-8550
- Fujisawa City Hospital
-
Kawasaki, Kanagawa, Japan, 211-8510
- Kanto Rosai Hospital
-
Kawasaki, Kanagawa, Japan, 211-8533
- Nippon Medical School Musashikosugi Hospital
-
Kawasaki, Kanagawa, Japan, 216-8511
- Saint Marianna University School of Medicine
-
Sagamihara, Kanagawa, Japan, 228-8522
- Sagamihara National Hospital
-
Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center
-
Yokohama, Kanagawa, Japan, 241-0815
- Kanagawa Cancer Center
-
Yokohama, Kanagawa, Japan, 245-0006
- International Goodwill Hospital
-
Yokohama, Kanagawa, Japan, 227-8502
- Showa University Fujigaoka Hospital
-
Yokohama, Kanagawa, Japan, 231-8553
- Social Insurance Yokohama Central Hospital
-
Yokohama, Kanagawa, Japan, 234-8503
- Saiseikai Yokohama City Nanbu Hospital
-
Yokohama, Kanagawa, Japan, 240
- Yokohama City Hospital
-
Yokohama, Kanagawa, Japan, 241-0811
- St. Marianna University Yokohama City Seibu Hospital
-
Yokohama-shi, Kanagawa, Japan, 224-8503
- Showa University Northern Yokohama Hospital
-
Yokosuka, Kanagawa, Japan, 238-8558
- Yokosuka Kyosai Hospital
-
-
Kochi
-
Nankoku, Kochi, Japan, 783-8505
- Kochi Medical School
-
-
Kumamoto
-
Uki, Kumamoto, Japan, 869-0
- National Hospital Organization - Kumamotominami Hospital
-
Yashiro, Kumamoto, Japan, 866-0826
- Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital
-
Yatsushiro, Kumamoto, Japan, 866-8660
- Yatsushiro Health Insurance General Hospital
-
-
Kyoto
-
Higashiyama-ku, Kyoto, Japan, 605-0981
- Kyoto First Red Cross Hospital
-
Kanigyou-ku, Kyoto, Japan, 602-8026
- Kyoto Second Red Cross Hospital
-
Nantan, Kyoto, Japan, 629-0197
- Nantan General Hospital
-
Sakyo-ku, Kyoto, Japan, 606-8507
- Kyoto University Hospital
-
-
Mie
-
Thu-shi, Mie, Japan, 514-8507
- Mie University Graduate School Of Medicine
-
-
Miyagi
-
Natori-shi, Miyagi, Japan, 981-1293
- Miyagi Cancer Center
-
Sendai, Miyagi, Japan, 980-0873
- Sendai Kousei Hospital
-
Sendai, Miyagi, Japan, 983-8520
- Sendai Medical Center
-
Sendai, Miyagi, Japan, 980-8574
- Tohoku University Graduate School of Medicine
-
Sendai, Miyagi, Japan, 981-0911
- Tohoku Rosai Hospital
-
-
Nagano
-
Iida, Nagano, Japan, 395-8502
- Iida Municipal Hospital
-
Komagane, Nagano, Japan, 399-4191
- Showa-Inan General Hospital
-
Matsumoto, Nagano, Japan, 390-8510
- Aizawa Hospital
-
Nagano-shi, Nagano, Japan, 381-8551
- Nagano Municipal Hospital
-
Nakano, Nagano, Japan, 383-0021
- Hokushin Hospital
-
-
Nagasaki
-
Magasaki-shi, Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
-
Nagasaki-shi, Nagasaki, Japan, 852-8511
- Japanese Red Cross Nagasaki Genbaku Hospital
-
Omura, Nagasaki, Japan, 856-8562
- National Hospital Organization Nagasaki Medical Center
-
Sasebo-shi, Nagasaki, Japan, 857-8511
- Sasebo City General Hospital
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- Nara Medical University Cancer Center
-
Yamatotakada, Nara, Japan, 635-0022
- Kenseikai Nara Coloproctology Center
-
-
Niigata
-
Nagaoka, Niigata, Japan, 940-8653
- Nagaoka Chuo General Hospital
-
Niigata-shi, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
-
Niigata-shi, Niigata, Japan, 951-8122
- Niigata University Medical and Dental Hospital
-
-
Oita
-
Yufu-shi, Oita, Japan, 879-5593
- Oita University Hospital
-
-
Okayama
-
Kurashiki, Okayama, Japan, 710-8602
- Kurashiki Central Hospital
-
Kurashiki-shi, Okayama, Japan, 701-0192
- Kawasaki Medical School
-
-
Osaka
-
Hirakata, Osaka, Japan, 573-8511
- Hoshigaoka Koseinenkin Hospital
-
Izumiotsu, Osaka, Japan, 595
- Izumiotsu Municipal Hospital
-
Izumisano, Osaka, Japan, 598-8577
- Rinku General Medical Center
-
Mino, Osaka, Japan, 562-0014
- Minoh City Hospital
-
Moriguchi, Osaka, Japan, 570-8507
- Kansai Medical University Takii Hospital
-
Osaka-shi, Osaka, Japan, 534-0021
- Osaka City General Hospital
-
Osaka-shi, Osaka, Japan, 543-8502
- Osaka Police Hospital
-
Osaka-shi, Osaka, Japan, 553-0003
- Osaka Kosei Nenkin Hospital
-
Osaka-shi, Osaka, Japan, 558-8558
- Osaka General Medical Center
-
Osakasayama, Osaka, Japan, 589-8511
- Kinki University School of Medicine
-
Sakai, Osaka, Japan, 590-0064
- Sakai Municipal Hospital
-
Sakai, Osaka, Japan, 599-8247
- Bell Land General Hospital
-
Sakai-shi, Osaka, Japan, 591-8025
- Osaka Rosai Hospital
-
Suita-shi, Osaka, Japan, 564-0082
- Suita Municipal Hospital
-
Takatsuki, Osaka, Japan, 569-8686
- Osaka Medical College
-
Tondabayashi, Osaka, Japan, 584-0082
- Saiseikai tondabayashi Hospital
-
-
Saitama
-
Fukaya, Saitama, Japan, 366-0052
- Fukaya Red Cross Hospital
-
Hasuda, Saitama, Japan, 349-0123
- Hasuda Hospital
-
Hidaka, Saitama, Japan, 350-1241
- Saitama Medical University International Medical Center
-
Kawagoe-shi, Saitama, Japan, 350-8550
- Saitama Medical School Hospital
-
Kitamoto, Saitama, Japan, 3648501
- Kitasato Institute Medical Center Hospital
-
Saitamaken, Saitama, Japan, 330-8503
- Omiya Medical Center ofJichi Medical School
-
Tokorozawa, Saitama, Japan, 359-1151
- National Hospital Organization - Nishisaitama-Chuo National Hospital
-
Tokorozawa, Saitama, Japan, 359-8513
- National Defense Medical College
-
-
Shiga
-
Otsu, Shiga, Japan, 520-0804
- Otsu Municipal Hospital
-
Otsu-shi, Shiga, Japan, 520-2192
- Shiga University of Medical Science
-
-
Shimane
-
Izumo-shi, Shimane, Japan, 693-0068
- Shimane Prefectural Central Hospital
-
-
Shizuoka
-
Fujieda, Shizuoka, Japan, 426-8677
- Fujieda Municipal General Hospital
-
Hamamatsu-shi, Shizuoka, Japan, 431-3192
- Hamamatsu University School of Medicine
-
Sunto-gun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
-
Yaizu, Shizuoka, Japan, 425-8505
- Yaizu Municipal Hospital
-
-
Tochigi
-
Ohtawawa, Tochigi, Japan, 324-0
- Ohtawara Red Cross Hospital
-
Shimotsuga-gun, Tochigi, Japan, 321-0293
- Dokkyo University School of Medicine
-
Shimotsuke-shi, Tochigi, Japan, 329-0498
- Jichi Medical School
-
Utsunomiya, Tochigi, Japan, 320-0834
- Tochigi Cancer Center
-
-
Tokushima
-
Anan, Tokushima, Japan, 770-8503
- Anan Kyoei Hospital
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-0033
- Juntendo University School of Medicine
-
Chuo-ku, Tokyo, Japan, 104-8560
- St. Luke's International Hospital
-
Fuchu, Tokyo, Japan, 183-8524
- Tokyo Metropolitan Fuchu Hospital
-
Higashiyamato, Tokyo, Japan, 207-0014
- Higashiyamato General Hospital
-
Kita-ku, Tokyo, Japan, 115-0053
- Tokyo-kita Social Insurance Hospital
-
Kodaira, Tokyo, Japan, 187-8510
- Showa General Hospital
-
Komae, Tokyo, Japan, 201
- Daisan Hospital
-
Meguro-ku, Tokyo, Japan, 153-8515
- Toho University Ohashi Hospital
-
Minato-ku, Tokyo, Japan, 105-8470
- Toranomon Hospital
-
Mitaka, Tokyo, Japan, 181-8611
- Kyorin University School of Medicine - Mitaka Campus
-
Nakano, Tokyo, Japan, 164-8607
- Nakano General Hospital
-
Shinjuku-ku, Tokyo, Japan, 169-0073
- Social Insurance Chuo General Hospital
-
Shinjyuku-ku, Tokyo, Japan, 162-8666
- Tokyo Women's Medical University
-
-
Tottori
-
Yonago, Tottori, Japan, 683-8503
- Tottori University - Faculty of Medicine
-
-
Toyama
-
Takaoka-shi, Toyama, Japan, 933-8555
- Koseiren Takaoka Hospital
-
Toyama-shi, Toyama, Japan, 930-8550
- Toyama Prefectural Central Hospital
-
-
Wakayama
-
Shingu, Wakayama, Japan, 647-0072
- Shingu Municipal Medical Center
-
Tanabe, Wakayama, Japan, 646-8588
- Social Insurance Kinan Hospital
-
Wakayama-shi, Wakayama, Japan, 641-8509
- Wakayama Medical University
-
-
Yamaguchi
-
Shimonoseki, Yamaguchi, Japan, 750-0061
- Shimonoseki Kosei Hospital
-
Shimonoseki, Yamaguchi, Japan, 240-8555
- National Hospital Organization - Kanmon Medical Center
-
Ube, Yamaguchi, Japan, 755-8505
- Yamaguchi University Graduate School of Medicine
-
-
Yamanashi
-
Chu-o-shi, Yamanashi, Japan, 409-3898
- University of Yamanashi Faculty of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 76 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
SYGDOMS KARAKTERISTIKA:
Histologisk bekræftet adenocarcinom i colon eller rectosigmoid
- Stadie II sygdom
- Har gennemgået kurativ (R0) resektion inden for de seneste 8 uger
- Ingen mistanke om arvelig tyktarmskræft
- Ingen alvorlige postoperative komplikationer
PATIENT KARAKTERISTIKA:
- ECOG ydeevne status 0-1
- WBC 3.500-12.000/mm³
- Absolut neutrofiltal ≥ 1.500/mm³
- Blodpladeantal ≥ 100.000/mm³
- Hæmoglobin ≥ 9,0 g/dL
- Bilirubin ≤ 2,0 mg/dL
- AST og ALT ≤ 100 IE/L
- Kreatinin ≤ 1,5 mg/dL
- Ikke gravid eller ammende
- Kan tage oral medicin
- Større organfunktioner bevares
- Ingen anden aktiv malignitet
Ingen af følgende forhold:
- Ukontrolleret diabetes mellitus
- Ukontrolleret hypertension
- Myokardieinfarkt eller ustabil angina pectoris inden for de seneste 6 måneder
- Levercirrhose
- Interstitiel lungebetændelse
- Lungefibrose
- Alvorlig emfysem
- Ingen psykiatrisk sygdom eller anden tilstand, der ville udelukke studiedeltagelse
FORUDSÆTNING SAMTYDLIG TERAPI:
- Se Sygdomskarakteristika
- Ingen forudgående kemoterapi
- Ingen forudgående eller samtidig strålebehandling
- Ingen samtidige profylaktiske vækstfaktorer
- Ingen samtidige biologiske responsmodifikatorer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: UFT adjuverende terapigruppe
UFT gives i en dosis på 500-600 mg/dag som tegafur i 2 opdelte doser efter måltider i 5 dage, efterfulgt af 2 dages hvile.
Denne en-uges cyklus gentages i et år.
Under protokolbehandling evalueres kliniske fund og laboratorieværdier hver måned.
Efter afslutningen af protokolbehandlingen følges patienterne op i henhold til skemaet defineret i undersøgelsesprotokollen i 5 år, indtil recidiv, anden malignitet eller død er bekræftet.
|
UFT gives i en dosis på 500-600 mg/dag som tegafur i 2 opdelte doser efter måltider i 5 dage, efterfulgt af 2 dages hvile.
Denne en-uges cyklus gentages i et år.
Andre navne:
|
|
Ingen indgriben: Observationsgruppe
Patienterne følges op uden adjuverende behandling i henhold til skemaet defineret i undersøgelsesprotokollen i 5 år, indtil recidiv, anden malignitet eller død er bekræftet.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sygdomsfri overlevelse
Tidsramme: 9 år
|
Sygdomsfri overlevelse er defineret som tiden fra indskrivningsdatoen til datoen for tilbagefald, andre maligne sygdomme eller død af enhver årsag, alt efter hvad der kommer først.
|
9 år
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse
Tidsramme: 9 år
|
Samlet overlevelse er defineret som tiden fra indskrivningsdatoen til datoen for dødsfald uanset årsag.
|
9 år
|
|
Typer og sværhedsgrad af uønskede hændelser
Tidsramme: 15 måneder
|
Typer og sværhedsgrad af uønskede hændelser fra datoen for påbegyndelse af protokolbehandlingen indtil 30 dage efter afslutningsdatoen for behandlingen evalueres i henhold til den japanske version af National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) af Translational Research Informatics Centrum.
|
15 måneder
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Kenichi Sugihara, MD, PhD, Tokyo Medical and Dental University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2006
Primær færdiggørelse (Faktiske)
1. oktober 2015
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
25. oktober 2006
Først indsendt, der opfyldte QC-kriterier
25. oktober 2006
Først opslået (Skøn)
26. oktober 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. september 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. september 2016
Sidst verificeret
1. juli 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Tegafur
Andre undersøgelses-id-numre
- CDR0000512573
- TMDU-BRI-CC-05-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .