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)

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

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Procedure: Mesorectal excision with lateral lymph node dissection; Procedure: Mesorectal excision without lateral lymph node excision

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.

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital
    • Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan, 470-1192
      • Fujita Health University
  • Chiba
    • Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
      • Chiba Cancer Center Hospital
    • Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
    • Sakura,Shimoshidu,564-1, Chiba, Japan, 285-8741
      • Toho University Sakura Hospital
    • Urayasu,Tomioka,2-1-1, Chiba, Japan, 279-0021
      • Jyuntendo Urayasu Hospital
  • Ehime
    • Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
      • National Kyushu Cancer Center
    • Kurume,Asahi-machi,67, Fukuoka, Japan, 830-0011
      • Kurume University School of Medicine
    • Kurume,Kokubumachi,155-1, Fukuoka, Japan, 839-0863
      • Kurume University Medical Center
  • Gunma
    • Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hiroshima
    • Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan, 734-8551
      • Hiroshima University, School of Medicine
    • Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan, 730-8518
      • Hiroshima City Hospital
  • Hokkaido
    • North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan, 060-0033
      • Sapporo-Kosei General Hospital
  • Hyogo
    • Amagasaki,Inabasou,3-1-69, Hyogo, Japan, 660-8511
      • Kansai Rosai Hospital
  • Ibaraki
    • Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan, 309-1793
      • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Ishikawa
    • Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan, 920-8530
      • Ishikawa Prefectual Central Hospital
  • Kanagawa
    • Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan, 213-8507
      • Teikyo University Hospital, Mizonokuchi
    • Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan, 228-8520
      • Kitasato University East Hospital
    • Sagamihara,Kitasato,1-15-1, Kanagawa, Japan, 228-8555
      • Kitasato University School of Medichine
    • Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
      • Kanagawa Cancer Center
    • Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
    • Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan, 224-8503
      • Showa University Northern Yokohama Hospital
  • Kyoto
    • Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan, 612-8555
      • National Hospital Organization Kyoto Medical Center
  • Miyagi
    • Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan, 981-1293
      • Miyagi Cancer Center
  • Nagano
    • Nagano,Tomitake,1333-1, Nagano, Japan, 381-8551
      • Nagano Municipal Hospital
  • Niigata
    • Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital
  • Oita
    • Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan, 879-5593
      • Oita University Fuculty of Medicine
  • Okayama
    • Okayama,Ifukucho,1-17-18, Okayama, Japan, 700-8511
      • Okayama Saiseikai General Hospital
  • Osaka
    • Minoh,Kayano,5-7-1, Osaka, Japan, 562-8562
      • Minoh City Hospital
    • Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
      • Osaka National Hospital
    • Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
      • Osaka Medical Center for Cancer and Cardiovascular Diseases
    • Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
      • Osaka City General Hospital
    • Sakai,Minamiyasuicho,1-1-1, Osaka, Japan, 590-0064
      • Sakai Municipal Hospital
    • Suita,Yamada-oka,2-2, Osaka, Japan, 565-0871
      • Osaka University Graduate School of Medicine
    • Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
      • Osaka Medical College
  • Saitama
    • Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan, 330-8503
      • Omiya Medical Center, Jichi Medical School
    • Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
      • National Defense Medical College
  • Shizuoka
    • Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
      • Sizuoka Cancer Center
  • Tochigi
    • Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
      • Tochigi Cancer Center
  • Tokyo
    • Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University Hospital
    • Chuo-ku,Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Meguro-ku,Ohashi,2-17-6, Tokyo, Japan, 153-0044
      • Toho University Ohashi Hospital
    • Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
      • Toranomon Hospital
    • Mitaka,Shinkawa,6-20-2, Tokyo, Japan, 181-8611
      • Kyorin University School of Medicine
    • Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan, 160-0023
      • Tokyo Medical University
    • Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
      • Keio University Hospital
  • Yamagata
    • Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
      • Yamagata Prefectural Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Preoperative criteria:

1. Histologically confirmed adenocarcinoma
2. Clinical stage II or III

3. 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)
4. Patient age is more than 20 and less than 75
5. PS: 0, 1
6. No past history of chemotherapy, pelvic surgery or radiation

7. Written informed consent

   Operative criteria:

8. Mesorectal excision is performed

9. Operative findings:

   • Main lesion of the tumor is located at the rectum
   • Lower tumor margin is below the peritoneal reflection
10. R0 after resection

Exclusion Criteria:

1. Multiple cancer patients
2. Pregnant patients
3. Psychological disorder
4. Steroid administration
5. Cardiac infarction within six months
6. Severe pulmonary emphysema and pulmonary fibrosis
7. Doctor's decision for exclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Procedure/Surgery: Mesorectal excision with lateral lymph node dissection	Procedure: Mesorectal excision with lateral lymph node dissection; Mesorectal excision with lateral lymph node dissection
Experimental: 2; Procedure/Surgery: Mesorectal excision without lateral lymph node excision	Procedure: Mesorectal excision without lateral lymph node excision; Mesorectal excision without lateral lymph node excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse-free survival	Until relapsing

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	5 years
Overall survival	Overall
Local-recurrence-free survival	Until local-recurrence
Incidence of major adverse events	5 years
Operative time	Operation day
Blood loss	Operation day
Incidence of sexual and urinary dysfunction	1 year

Collaborators and Investigators

• Sponsor: Haruhiko Fukuda
• Collaborators: Ministry of Health, Labour and Welfare, Japan
• Investigators: Study Chair: Shin Fujita, MD, National Cancer Center Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Rectal Cancer; Lymph Node Dissection; Rectal Surgery; Autonomic Nerves; Stage II, III lower rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: JCOG0212; C000000034 (Registry Identifier: UMIN-CTR)