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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190541
First received: September 13, 2005
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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

Condition Intervention Phase
Rectal Neoplasms
Procedure: Mesorectal excision with lateral lymph node dissection
Procedure: Mesorectal excision without lateral lymph node excision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Relapse-free survival [ Time Frame: Until relapsing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Overall ] [ Designated as safety issue: No ]
  • Local-recurrence-free survival [ Time Frame: Until local-recurrence ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of major adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Operative time [ Time Frame: Operation day ] [ Designated as safety issue: Yes ]
  • Blood loss [ Time Frame: Operation day ] [ Designated as safety issue: Yes ]
  • Incidence of sexual and urinary dysfunction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 700
Study Start Date: June 2003
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   21 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190541

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00190541     History of Changes
Other Study ID Numbers: JCOG0212  C000000034 
Study First Received: September 13, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
Rectal Cancer
Lymph Node Dissection
Rectal Surgery
Autonomic Nerves
Stage II, III lower rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 29, 2016