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Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

Primary Purpose

Rectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Mesorectal excision with lateral lymph node dissection
Mesorectal excision without lateral lymph node excision
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Rectal Cancer, Lymph Node Dissection, Rectal Surgery, Autonomic Nerves, Stage II, III lower rectal cancer

Eligibility Criteria

21 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: Main lesion of the tumor is located at the rectum Lower tumor margin is below the peritoneal reflection R0 after resection Exclusion Criteria: Multiple cancer patients Pregnant patients Psychological disorder Steroid administration Cardiac infarction within six months Severe pulmonary emphysema and pulmonary fibrosis Doctor's decision for exclusion

Sites / Locations

  • Aichi Cancer Center Hospital
  • Fujita Health University
  • Chiba Cancer Center Hospital
  • National Cancer Center Hospital East
  • Toho University Sakura Hospital
  • Jyuntendo Urayasu Hospital
  • National Hospital Organization Shikoku Cancer Center
  • National Kyushu Cancer Center
  • Kurume University School of Medicine
  • Kurume University Medical Center
  • Gunma Prefectural Cancer Center
  • Hiroshima University, School of Medicine
  • Hiroshima City Hospital
  • Sapporo-Kosei General Hospital
  • Kansai Rosai Hospital
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Ishikawa Prefectual Central Hospital
  • Teikyo University Hospital, Mizonokuchi
  • Kitasato University East Hospital
  • Kitasato University School of Medichine
  • Kanagawa Cancer Center
  • Yokohama City University Medical Center
  • Showa University Northern Yokohama Hospital
  • National Hospital Organization Kyoto Medical Center
  • Miyagi Cancer Center
  • Nagano Municipal Hospital
  • Niigata Cancer Center Hospital
  • Oita University Fuculty of Medicine
  • Okayama Saiseikai General Hospital
  • Minoh City Hospital
  • Osaka National Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Osaka City General Hospital
  • Sakai Municipal Hospital
  • Osaka University Graduate School of Medicine
  • Osaka Medical College
  • Omiya Medical Center, Jichi Medical School
  • National Defense Medical College
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • Tokyo Medical and Dental University Hospital
  • National Cancer Center Hospital
  • Toho University Ohashi Hospital
  • Toranomon Hospital
  • Kyorin University School of Medicine
  • Tokyo Medical University
  • Keio University Hospital
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Procedure/Surgery: Mesorectal excision with lateral lymph node dissection

Procedure/Surgery: Mesorectal excision without lateral lymph node excision

Outcomes

Primary Outcome Measures

Relapse-free survival

Secondary Outcome Measures

Overall survival
Local-recurrence-free survival
Incidence of adverse events
Incidence of major adverse events
Operative time
Blood loss
Incidence of sexual and urinary dysfunction

Full Information

First Posted
September 13, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00190541
Brief Title
Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)
Official Title
Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Rectal Cancer, Lymph Node Dissection, Rectal Surgery, Autonomic Nerves, Stage II, III lower rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Mesorectal excision with lateral lymph node dissection
Arm Title
2
Arm Type
Experimental
Arm Description
Procedure/Surgery: Mesorectal excision without lateral lymph node excision
Intervention Type
Procedure
Intervention Name(s)
Mesorectal excision with lateral lymph node dissection
Intervention Description
Mesorectal excision with lateral lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Mesorectal excision without lateral lymph node excision
Intervention Description
Mesorectal excision without lateral lymph node excision
Primary Outcome Measure Information:
Title
Relapse-free survival
Time Frame
Until relapsing
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Overall
Title
Local-recurrence-free survival
Time Frame
Until local-recurrence
Title
Incidence of adverse events
Time Frame
5 years
Title
Incidence of major adverse events
Time Frame
5 years
Title
Operative time
Time Frame
Operation day
Title
Blood loss
Time Frame
Operation day
Title
Incidence of sexual and urinary dysfunction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: Main lesion of the tumor is located at the rectum Lower tumor margin is below the peritoneal reflection R0 after resection Exclusion Criteria: Multiple cancer patients Pregnant patients Psychological disorder Steroid administration Cardiac infarction within six months Severe pulmonary emphysema and pulmonary fibrosis Doctor's decision for exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin Fujita, MD
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fujita Health University
City
Toyoake,Kutsukake-cho,Dengakugakubo,1-98
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Chiba Cancer Center Hospital
City
Chiba,Chuo-ku,Nitona-cho,666-2
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Toho University Sakura Hospital
City
Sakura,Shimoshidu,564-1
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Jyuntendo Urayasu Hospital
City
Urayasu,Tomioka,2-1-1
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka,Minami-ku,Notame,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kurume University School of Medicine
City
Kurume,Asahi-machi,67
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kurume University Medical Center
City
Kurume,Kokubumachi,155-1
State/Province
Fukuoka
ZIP/Postal Code
839-0863
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota,Takabayashi-nishi-cho,617-1
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Hiroshima University, School of Medicine
City
Hiroshima,Minami-ku,Kasumi,1-2-3
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hiroshima City Hospital
City
Hiroshima,Naka-ku,Motomachi,7-33
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Sapporo-Kosei General Hospital
City
North-3,East8-5,Chuou-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Kansai Rosai Hospital
City
Amagasaki,Inabasou,3-1-69
State/Province
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Ishikawa Prefectual Central Hospital
City
Kanazawa,Kuratsuki-Higashi,2-1
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Teikyo University Hospital, Mizonokuchi
City
Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Kitasato University East Hospital
City
Sagamihara,Asamizodai,2-1-1
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Kitasato University School of Medichine
City
Sagamihara,Kitasato,1-15-1
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama,Minami-ku,Urafunecho,4-57
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Yokohama,Tsuzuki-ku,Chigasakichuo,35-1
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori,Medeshima-Shiode,Nodayama,47-1
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Nagano Municipal Hospital
City
Nagano,Tomitake,1333-1
State/Province
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Oita University Fuculty of Medicine
City
Oita,Hasama-machi,Oogaoka,1-1
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Okayama Saiseikai General Hospital
City
Okayama,Ifukucho,1-17-18
State/Province
Okayama
ZIP/Postal Code
700-8511
Country
Japan
Facility Name
Minoh City Hospital
City
Minoh,Kayano,5-7-1
State/Province
Osaka
ZIP/Postal Code
562-8562
Country
Japan
Facility Name
Osaka National Hospital
City
Osaka,Chuo-ku,Hoenzaka,2-1-14
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Sakai Municipal Hospital
City
Sakai,Minamiyasuicho,1-1-1
State/Province
Osaka
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Osaka University Graduate School of Medicine
City
Suita,Yamada-oka,2-2
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Medical College
City
Takatsuki,Daigakucho,2-7
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Omiya Medical Center, Jichi Medical School
City
Saitama,Omiya-ku,Amanuma-cho,1-847
State/Province
Saitama
ZIP/Postal Code
330-8503
Country
Japan
Facility Name
National Defense Medical College
City
Tokorozawa,Namiki,3-2
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Sizuoka Cancer Center
City
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya,Yohnan,4-9-13
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku,Yushima,1-5-45
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji, 5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toho University Ohashi Hospital
City
Meguro-ku,Ohashi,2-17-6
State/Province
Tokyo
ZIP/Postal Code
153-0044
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku,Toranomon,2-2-2
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Kyorin University School of Medicine
City
Mitaka,Shinkawa,6-20-2
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Medical University
City
Shinjuku-ku,Nishi-shinjuku,6-7-1
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku,Shinanomachi,35
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32162301
Citation
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.
Results Reference
derived
PubMed Identifier
27519616
Citation
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.
Results Reference
derived
PubMed Identifier
22591948
Citation
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

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