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| ID | Type | Description | Link |
|---|---|---|---|
| C000000034 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Ministry of Health, Labour and Welfare, Japan | OTHER_GOV |
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The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer
Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Procedure/Surgery: Mesorectal excision with lateral lymph node dissection |
|
| 2 | Experimental | Procedure/Surgery: Mesorectal excision without lateral lymph node excision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesorectal excision with lateral lymph node dissection | Procedure | Mesorectal excision with lateral lymph node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | Until relapsing |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall | |
| Local-recurrence-free survival | Until local-recurrence | |
| Incidence of adverse events |
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Inclusion Criteria:
Preoperative criteria:
Histologically confirmed adenocarcinoma
Clinical stage II or III
Preoperative findings:
Patient age is more than 20 and less than 75
PS: 0, 1
No past history of chemotherapy, pelvic surgery or radiation
Written informed consent
Operative criteria:
Mesorectal excision is performed
Operative findings:
R0 after resection
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shin Fujita, MD | National Cancer Center Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Nagoya,Chikusa-ku,Kanokoden,1-1 | Aichi-ken | 464-8681 | Japan | ||
| Fujita Health University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32162301 | Derived | Tsukamoto S, Fujita S, Ota M, Mizusawa J, Shida D, Kanemitsu Y, Ito M, Shiomi A, Komori K, Ohue M, Akazai Y, Shiozawa M, Yamaguchi T, Bando H, Tsuchida A, Okamura S, Akagi Y, Takiguchi N, Saida Y, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Long-term follow-up of the randomized trial of mesorectal excision with or without lateral lymph node dissection in rectal cancer (JCOG0212). Br J Surg. 2020 Apr;107(5):586-594. doi: 10.1002/bjs.11513. Epub 2020 Mar 12. | |
| 27519616 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Mesorectal excision without lateral lymph node excision | Procedure | Mesorectal excision without lateral lymph node excision |
|
| 5 years |
| Incidence of major adverse events | 5 years |
| Operative time | Operation day |
| Blood loss | Operation day |
| Incidence of sexual and urinary dysfunction | 1 year |
| Toyoake,Kutsukake-cho,Dengakugakubo,1-98 |
| Aichi-ken |
| 470-1192 |
| Japan |
| Chiba Cancer Center Hospital | Chiba,Chuo-ku,Nitona-cho,666-2 | Chiba | 260-8717 | Japan |
| National Cancer Center Hospital East | Kashiwa,Kashiwanoha,6-5-1 | Chiba | 277-8577 | Japan |
| Toho University Sakura Hospital | Sakura,Shimoshidu,564-1 | Chiba | 285-8741 | Japan |
| Jyuntendo Urayasu Hospital | Urayasu,Tomioka,2-1-1 | Chiba | 279-0021 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama,Horinouchi,13 | Ehime | 790-0007 | Japan |
| National Kyushu Cancer Center | Fukuoka,Minami-ku,Notame,3-1-1 | Fukuoka | 811-1395 | Japan |
| Kurume University School of Medicine | Kurume,Asahi-machi,67 | Fukuoka | 830-0011 | Japan |
| Kurume University Medical Center | Kurume,Kokubumachi,155-1 | Fukuoka | 839-0863 | Japan |
| Gunma Prefectural Cancer Center | Ota,Takabayashi-nishi-cho,617-1 | Gunma | 373-8550 | Japan |
| Hiroshima University, School of Medicine | Hiroshima,Minami-ku,Kasumi,1-2-3 | Hiroshima | 734-8551 | Japan |
| Hiroshima City Hospital | Hiroshima,Naka-ku,Motomachi,7-33 | Hiroshima | 730-8518 | Japan |
| Sapporo-Kosei General Hospital | North-3,East8-5,Chuou-ku,Sapporo | Hokkaido | 060-0033 | Japan |
| Kansai Rosai Hospital | Amagasaki,Inabasou,3-1-69 | Hyōgo | 660-8511 | Japan |
| Ibaraki Kenritsu Chuo Hospital & Cancer Center | Nishi-ibarakigun,Tomobemachi,Koibuchi,6528 | Ibaraki | 309-1793 | Japan |
| Ishikawa Prefectual Central Hospital | Kanazawa,Kuratsuki-Higashi,2-1 | Ishikawa-ken | 920-8530 | Japan |
| Teikyo University Hospital, Mizonokuchi | Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3 | Kanagawa | 213-8507 | Japan |
| Kitasato University East Hospital | Sagamihara,Asamizodai,2-1-1 | Kanagawa | 228-8520 | Japan |
| Kitasato University School of Medichine | Sagamihara,Kitasato,1-15-1 | Kanagawa | 228-8555 | Japan |
| Kanagawa Cancer Center | Yokohama,Asahi-ku,Nakao,1-1-2 | Kanagawa | 241-0815 | Japan |
| Yokohama City University Medical Center | Yokohama,Minami-ku,Urafunecho,4-57 | Kanagawa | 232-0024 | Japan |
| Showa University Northern Yokohama Hospital | Yokohama,Tsuzuki-ku,Chigasakichuo,35-1 | Kanagawa | 224-8503 | Japan |
| National Hospital Organization Kyoto Medical Center | Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1 | Kyoto | 612-8555 | Japan |
| Miyagi Cancer Center | Natori,Medeshima-Shiode,Nodayama,47-1 | Miyagi | 981-1293 | Japan |
| Nagano Municipal Hospital | Nagano,Tomitake,1333-1 | Nagano | 381-8551 | Japan |
| Niigata Cancer Center Hospital | Niigata,Kawagishi-cho,2-15-3 | Niigata | 951-8566 | Japan |
| Oita University Fuculty of Medicine | Oita,Hasama-machi,Oogaoka,1-1 | Oita Prefecture | 879-5593 | Japan |
| Okayama Saiseikai General Hospital | Okayama,Ifukucho,1-17-18 | Okayama-ken | 700-8511 | Japan |
| Minoh City Hospital | Minoh,Kayano,5-7-1 | Osaka | 562-8562 | Japan |
| Osaka National Hospital | Osaka,Chuo-ku,Hoenzaka,2-1-14 | Osaka | 540-0006 | Japan |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka,Higashinari-ku,Nakamichi,1-3-3 | Osaka | 537-8511 | Japan |
| Osaka City General Hospital | Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22 | Osaka | 534-0021 | Japan |
| Sakai Municipal Hospital | Sakai,Minamiyasuicho,1-1-1 | Osaka | 590-0064 | Japan |
| Osaka University Graduate School of Medicine | Suita,Yamada-oka,2-2 | Osaka | 565-0871 | Japan |
| Osaka Medical College | Takatsuki,Daigakucho,2-7 | Osaka | 569-0801 | Japan |
| Omiya Medical Center, Jichi Medical School | Saitama,Omiya-ku,Amanuma-cho,1-847 | Saitama | 330-8503 | Japan |
| National Defense Medical College | Tokorozawa,Namiki,3-2 | Saitama | 359-8513 | Japan |
| Sizuoka Cancer Center | Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007 | Shizuoka | 411-8777 | Japan |
| Tochigi Cancer Center | Utsunomiya,Yohnan,4-9-13 | Tochigi | 320-0834 | Japan |
| Tokyo Medical and Dental University Hospital | Bunkyo-ku,Yushima,1-5-45 | Tokyo | 113-8519 | Japan |
| National Cancer Center Hospital | Chuo-ku,Tsukiji, 5-1-1 | Tokyo | 104-0045 | Japan |
| Toho University Ohashi Hospital | Meguro-ku,Ohashi,2-17-6 | Tokyo | 153-0044 | Japan |
| Toranomon Hospital | Minato-ku,Toranomon,2-2-2 | Tokyo | 105-8470 | Japan |
| Kyorin University School of Medicine | Mitaka,Shinkawa,6-20-2 | Tokyo | 181-8611 | Japan |
| Tokyo Medical University | Shinjuku-ku,Nishi-shinjuku,6-7-1 | Tokyo | 160-0023 | Japan |
| Keio University Hospital | Shinjuku-ku,Shinanomachi,35 | Tokyo | 160-8582 | Japan |
| Yamagata Prefectural Central Hospital | Yamagata,Aoyagi,1800 | Yamagata | 990-2292 | Japan |
| Derived |
| Saito S, Fujita S, Mizusawa J, Kanemitsu Y, Saito N, Kinugasa Y, Akazai Y, Ota M, Ohue M, Komori K, Shiozawa M, Yamaguchi T, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Male sexual dysfunction after rectal cancer surgery: Results of a randomized trial comparing mesorectal excision with and without lateral lymph node dissection for patients with lower rectal cancer: Japan Clinical Oncology Group Study JCOG0212. Eur J Surg Oncol. 2016 Dec;42(12):1851-1858. doi: 10.1016/j.ejso.2016.07.010. Epub 2016 Jul 30. |
| 22591948 | Derived | Fujita S, Akasu T, Mizusawa J, Saito N, Kinugasa Y, Kanemitsu Y, Ohue M, Fujii S, Shiozawa M, Yamaguchi T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Postoperative morbidity and mortality after mesorectal excision with and without lateral lymph node dissection for clinical stage II or stage III lower rectal cancer (JCOG0212): results from a multicentre, randomised controlled, non-inferiority trial. Lancet Oncol. 2012 Jun;13(6):616-21. doi: 10.1016/S1470-2045(12)70158-4. Epub 2012 May 15. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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