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Rectal NeoplasmsPhase 3NCT00190541

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

A Phase 3 study testing Mesorectal excision with lateral lymph node dissection and Mesorectal excision without lateral lymph node excision in people with Rectal Neoplasms, run by Haruhiko Fukuda at 48 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 21 to 74 years
Conditions the study is for
Rectal Neoplasms
What is being tested?
Mesorectal excision with lateral lymph node dissection and Mesorectal excision without lateral lymph node excision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
48 sitesJapan
Study dates
Jun 2003to Jun 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Japan48 sites

  • Kansai Rosai Hospital

    Amagasaki,Inabasou,3-1-69, Hyōgo, 660-8511

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519

  • Chiba Cancer Center Hospital

    Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-ku,Tsukiji, 5-1-1, Tokyo, 104-0045

  • National Kyushu Cancer Center

    Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395

  • Hiroshima University, School of Medicine

    Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, 734-8551

  • Hiroshima City Hospital

    Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, 730-8518

  • Ishikawa Prefectual Central Hospital

    Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, 920-8530

  • National Cancer Center Hospital East

    Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577

  • Teikyo University Hospital, Mizonokuchi

    Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, 213-8507

  • Kurume University School of Medicine

    Kurume,Asahi-machi,67, Fukuoka, 830-0011

  • Kurume University Medical Center

    Kurume,Kokubumachi,155-1, Fukuoka, 839-0863

  • National Hospital Organization Kyoto Medical Center

    Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, 612-8555

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama,Horinouchi,13, Ehime, 790-0007

  • Toho University Ohashi Hospital

    Meguro-ku,Ohashi,2-17-6, Tokyo, 153-0044

  • Toranomon Hospital

    Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470

  • Minoh City Hospital

    Minoh,Kayano,5-7-1, Osaka, 562-8562

  • Kyorin University School of Medicine

    Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611

  • Nagano Municipal Hospital

    Nagano,Tomitake,1333-1, Nagano, 381-8551

  • Aichi Cancer Center Hospital

    Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681

  • Miyagi Cancer Center

    Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293

  • Niigata Cancer Center Hospital

    Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566

  • Ibaraki Kenritsu Chuo Hospital & Cancer Center

    Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793

  • Sapporo-Kosei General Hospital

    North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, 060-0033

  • Oita University Fuculty of Medicine

    Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, 879-5593

  • Okayama Saiseikai General Hospital

    Okayama,Ifukucho,1-17-18, Okayama-ken, 700-8511

  • Osaka National Hospital

    Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511

  • Osaka City General Hospital

    Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021

  • Gunma Prefectural Cancer Center

    Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550

  • Kitasato University East Hospital

    Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520

  • Kitasato University School of Medichine

    Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555

  • Omiya Medical Center, Jichi Medical School

    Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, 330-8503

  • Sakai Municipal Hospital

    Sakai,Minamiyasuicho,1-1-1, Osaka, 590-0064

  • Toho University Sakura Hospital

    Sakura,Shimoshidu,564-1, Chiba, 285-8741

  • Tokyo Medical University

    Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, 160-0023

  • Keio University Hospital

    Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582

  • Osaka University Graduate School of Medicine

    Suita,Yamada-oka,2-2, Osaka, 565-0871

  • Sizuoka Cancer Center

    Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777

  • Osaka Medical College

    Takatsuki,Daigakucho,2-7, Osaka, 569-0801

  • National Defense Medical College

    Tokorozawa,Namiki,3-2, Saitama, 359-8513

  • Fujita Health University

    Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192

  • Jyuntendo Urayasu Hospital

    Urayasu,Tomioka,2-1-1, Chiba, 279-0021

  • Tochigi Cancer Center

    Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834

  • Yamagata Prefectural Central Hospital

    Yamagata,Aoyagi,1800, Yamagata, 990-2292

  • Kanagawa Cancer Center

    Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815

  • Yokohama City University Medical Center

    Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, 232-0024

  • Showa University Northern Yokohama Hospital

    Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, 224-8503

Other trials in Japan

About this study

Official title: 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

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.

Being tested
Mesorectal excision with lateral lymph node dissection, Mesorectal excision without lateral lymph node excision
Keywords
Rectal Cancer, Lymph Node Dissection, Rectal Surgery, Autonomic Nerves, Stage II, III lower rectal cancer
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesorectal excision with lateral lymph node dissectionProcedure or surgery

    Mesorectal excision with lateral lymph node dissection

  • Mesorectal excision without lateral lymph node excisionProcedure or surgery

    Mesorectal excision without lateral lymph node excision

Study groups in NCT00190541
Study groupRoleWhat they receive
1Active comparatorProcedure/Surgery: Mesorectal excision with lateral lymph node dissection
Receives: Procedure: Mesorectal excision with lateral lymph node dissection
2ExperimentalProcedure/Surgery: Mesorectal excision without lateral lymph node excision
Receives: Procedure: Mesorectal excision without lateral lymph node excision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free survival

    Measured: Until relapsing

Secondary outcomes (7)

  1. Overall survival

    Measured: Overall

  2. Local-recurrence-free survival

    Measured: Until local-recurrence

  3. Incidence of adverse events

    Measured: 5 years

  4. Incidence of major adverse events

    Measured: 5 years

  5. Operative time

    Measured: Operation day

  6. Blood loss

    Measured: Operation day

  7. Incidence of sexual and urinary dysfunction

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00190541
Sponsor's protocol ID
JCOG0212
Other IDs
C000000034
Status last verified
Sep 2016
First submitted
13 Sep 2005
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mesorectal excision with lateral lymph node dissection and Mesorectal excision without lateral lymph node excision in people with Rectal Neoplasms, run by Haruhiko Fukuda at 48 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival (time frame: Until relapsing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00190541, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.

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