Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)
Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)
2 other identifiers
interventional
700
1 country
48
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
Longer than P75 for phase_3
48 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
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 22, 2016
September 1, 2016
12 years
September 13, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse-free survival
Until relapsing
Secondary Outcomes (7)
Overall survival
Overall
Local-recurrence-free survival
Until local-recurrence
Incidence of adverse events
5 years
Incidence of major adverse events
5 years
Operative time
Operation day
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORProcedure/Surgery: Mesorectal excision with lateral lymph node dissection
2
EXPERIMENTALProcedure/Surgery: Mesorectal excision without lateral lymph node excision
Interventions
Mesorectal excision with lateral lymph node dissection
Mesorectal excision without lateral lymph node excision
Eligibility Criteria
You may qualify if:
- Preoperative criteria:
- Histologically confirmed adenocarcinoma
- Clinical stage II or III
- Preoperative findings:
- Main lesion of the tumor is located at the rectum
- Lower tumor margin is below the peritoneal reflection
- No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
- No invasion to other organ (s)
- 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:
- +3 more criteria
You may not qualify if:
- Multiple cancer patients
- Pregnant patients
- Psychological disorder
- Steroid administration
- Cardiac infarction within six months
- Severe pulmonary emphysema and pulmonary fibrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (48)
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Fujita Health University
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
Related Publications (3)
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.
PMID: 32162301DERIVEDSaito 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.
PMID: 27519616DERIVEDFujita 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.
PMID: 22591948DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shin Fujita, MD
National Cancer Center Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
June 1, 2003
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 22, 2016
Record last verified: 2016-09