CClinicalTrials.gg
Sign In
CompletedNCT00190541Updated Sep 22, 2016

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

A Phase 3 interventional study of Mesorectal excision with lateral lymph node dissection and Mesorectal excision without lateral lymph node excision in Rectal Neoplasms, sponsored by Haruhiko Fukuda. Completed at 48 sites in Japan. Open to participants aged 21 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-09-22.

Sponsored by Haruhiko Fukuda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
21 Years to 74 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Rectal Neoplasms

Browse trials for

Keywords

  • Rectal Cancer
  • Lymph Node Dissection
  • Rectal Surgery
  • Autonomic Nerves
  • Stage II, III lower rectal cancer
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 700 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Haruhiko Fukuda is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
700 participants (actual)

Study arms

  • Active comparator
    1

    Procedure/Surgery: Mesorectal excision with lateral lymph node dissection

    Procedure: 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

Interventions

  • ProcedureMesorectal excision with lateral lymph node dissection

    Mesorectal excision with lateral lymph node dissection

  • ProcedureMesorectal excision without lateral lymph node excision

    Mesorectal excision without lateral lymph node excision

06

What researchers measure

Primary outcomes

  1. Relapse-free survival

    Time frame: Until relapsing

Secondary outcomes

  1. Overall survival

    Time frame: Overall

  2. Local-recurrence-free survival

    Time frame: Until local-recurrence

  3. Incidence of adverse events

    Time frame: 5 years

  4. Incidence of major adverse events

    Time frame: 5 years

  5. Operative time

    Time frame: Operation day

  6. Blood loss

    Time frame: Operation day

  7. Incidence of sexual and urinary dysfunction

    Time frame: 1 year

07

Study locations

48 sites
  • Aichi Cancer Center Hospital
    Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi 464-8681, Japan
  • Fujita Health University
    Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi 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, Hyogo 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 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 879-5593, Japan
  • Okayama Saiseikai General Hospital
    Okayama,Ifukucho,1-17-18, Okayama 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
08

References and documents

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. PubMed 32162301 ↗
  • 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. PubMed 27519616 ↗
  • 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. PubMed 22591948 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00190541
Lead sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
Responsible party
Haruhiko Fukuda (JCOG Data Center, Japan Clinical Oncology Group) — Sponsor-investigator
First posted
Sep 19, 2005
Start date
Jun 2003
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Sep 22, 2016

Study contacts

Shin Fujita, MD
study chair · National Cancer Center Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rectal Neoplasms→

Other studies from this sponsor

Haruhiko Fukuda

Start the discussion