A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
NCT ID: NCT00147134
Last Updated: 2016-09-22
Study Results
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Basic Information
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COMPLETED
PHASE3
1050 participants
INTERVENTIONAL
2004-11-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Procedure/Surgery: open colectomy
open colectomy
Procedure/Surgery: open colectomy
2
Procedure/Surgery: laparoscopic colectomy
laparoscopic colectomy
Procedure/Surgery: laparoscopic colectomy
Interventions
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open colectomy
Procedure/Surgery: open colectomy
laparoscopic colectomy
Procedure/Surgery: laparoscopic colectomy
Eligibility Criteria
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Inclusion Criteria
2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
3. T3 or deeper lesion without involvement of other organs
4. Without multiple lesion other than carcinoma in situ
5. Cancer classified as N0-2 and M0, according to the TNM classification system
6. Tumor size \< 8 cm
7. No bowel obstruction
8. Age 20 \< and \> 75 years
9. Sufficient organ function
10. No history of gastrointestinal surgery
11. No history of chemotherapy or radiotherapy
12. Provided written informed consent
Exclusion Criteria
2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
3. Pregnant or lactating women
4. Severe mental disease
5. Continuous systemic steroid therapy
20 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
Principal Investigators
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Seigo Kitano, MD, PhD,FACS
Role: STUDY_CHAIR
Oita University
Locations
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Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Toho University Sakura Hospital
Sakura,Shimoshidu,564-1, Chiba, Japan
Jyuntendo Urayasu Hospital
Urayasu,Tomioka,2-1-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, Japan
Hiroshima University, School of Medicine
Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan
Ishikawa Prefectual Central Hospital
Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, Japan
Teikyo University Hospital, Mizonokuchi
Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan
Kitasato University East Hospital
Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan
Kitasato University School of Medichine
Sagamihara,Kitasato,1-15-1, Kanagawa, Japan
Showa University Northern Yokohama Hospital
Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan
National Hospital Organization Kyoto Medical Center
Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan
Nagano Municipal Hospital
Nagano,Tomitake,1333-1, Nagano, Japan
Oita University Faculty of Medicine
Yufu city,Hasama-machi, 1-1, Oita Prefecture, Japan
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan
Osaka University Graduate School of Medicine
Suita,Yamada-oka,2-2, Osaka, Japan
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, Japan
Omiya Medical Center, Jichi Medical School
Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Toho University Ohashi Hospital
Meguro-ku,Ohashi,2-17-6, Tokyo, Japan
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, Japan
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
Countries
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References
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Saito S, Akagi T, Katayama H, Wakabayashi M, Inomata M, Yamamoto S, Ito M, Kinugasa Y, Egi H, Munakata Y, Kokuba Y, Bando H, Yasui M, Ikeda M, Nakajima K, Shida D, Kanemitsu Y, Kitano S; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404). Ann Gastroenterol Surg. 2021 Aug 9;5(6):804-812. doi: 10.1002/ags3.12475. eCollection 2021 Nov.
Nishizawa Y, Akagi T, Inomata M, Katayama H, Mizusawa J, Yamamoto S, Ito M, Masaki T, Watanabe M, Shimada Y, Kitano S. Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404). Ann Gastroenterol Surg. 2019 Apr 4;3(3):310-317. doi: 10.1002/ags3.12246. eCollection 2019 May.
Fujii S, Akagi T, Inomata M, Katayama H, Mizusawa J, Ota M, Saito S, Kinugasa Y, Yamaguchi S, Sato T, Kitano S; Japan Clinical Oncology Group. Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404. Ann Gastroenterol Surg. 2019 Mar 26;3(3):301-309. doi: 10.1002/ags3.12245. eCollection 2019 May.
Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F, Saida Y, Hasegawa H, Akagi T, Sugihara K, Yamaguchi T, Masaki T, Fukunaga Y, Murata K, Okajima M, Moriya Y, Shimada Y. Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):261-268. doi: 10.1016/S2468-1253(16)30207-2. Epub 2017 Feb 2.
Yamamoto S, Inomata M, Katayama H, Mizusawa J, Etoh T, Konishi F, Sugihara K, Watanabe M, Moriya Y, Kitano S; Japan Clinical Oncology Group Colorectal Cancer Study Group. Short-term surgical outcomes from a randomized controlled trial to evaluate laparoscopic and open D3 dissection for stage II/III colon cancer: Japan Clinical Oncology Group Study JCOG 0404. Ann Surg. 2014 Jul;260(1):23-30. doi: 10.1097/SLA.0000000000000499.
Related Links
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Related Info
Other Identifiers
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C000000105
Identifier Type: -
Identifier Source: secondary_id
JCOG0404
Identifier Type: -
Identifier Source: org_study_id
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