Clinical trial NCT00190541: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Neoplasms
Keywords: Rectal Cancer
Lymph Node Dissection
Rectal Surgery
Autonomic Nerves
Stage II, III lower rectal cancer
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-19
Enrollment: 700
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Relapse-free survival
timeFrame: Until relapsing
Secondary outcomes:
measure: Overall survival
timeFrame: Overall
measure: Local-recurrence-free survival
timeFrame: Until local-recurrence
measure: Incidence of adverse events
timeFrame: 5 years
measure: Incidence of major adverse events
timeFrame: 5 years
measure: Operative time
timeFrame: Operation day
measure: Blood loss
timeFrame: Operation day
measure: Incidence of sexual and urinary dysfunction
timeFrame: 1 year
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Toyoake,Kutsukake-cho,Dengakugakubo,1-98
country: Japan
facility: Fujita Health University
state: Aichi
city: Chiba,Chuo-ku,Nitona-cho,666-2
country: Japan
facility: Chiba Cancer Center Hospital
state: Chiba
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sakura,Shimoshidu,564-1
country: Japan
facility: Toho University Sakura Hospital
state: Chiba
city: Urayasu,Tomioka,2-1-1
country: Japan
facility: Jyuntendo Urayasu Hospital
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka,Minami-ku,Notame,3-1-1
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: Kurume,Asahi-machi,67
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Kurume,Kokubumachi,155-1
country: Japan
facility: Kurume University Medical Center
state: Fukuoka
city: Ota,Takabayashi-nishi-cho,617-1
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Hiroshima,Minami-ku,Kasumi,1-2-3
country: Japan
facility: Hiroshima University, School of Medicine
state: Hiroshima
city: Hiroshima,Naka-ku,Motomachi,7-33
country: Japan
facility: Hiroshima City Hospital
state: Hiroshima
city: North-3,East8-5,Chuou-ku,Sapporo
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Amagasaki,Inabasou,3-1-69
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Kanazawa,Kuratsuki-Higashi,2-1
country: Japan
facility: Ishikawa Prefectual Central Hospital
state: Ishikawa
city: Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3
country: Japan
facility: Teikyo University Hospital, Mizonokuchi
state: Kanagawa
city: Sagamihara,Asamizodai,2-1-1
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Sagamihara,Kitasato,1-15-1
country: Japan
facility: Kitasato University School of Medichine
state: Kanagawa
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama,Minami-ku,Urafunecho,4-57
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokohama,Tsuzuki-ku,Chigasakichuo,35-1
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1
country: Japan
facility: National Hospital Organization Kyoto Medical Center
state: Kyoto
city: Natori,Medeshima-Shiode,Nodayama,47-1
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Nagano,Tomitake,1333-1
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Oita,Hasama-machi,Oogaoka,1-1
country: Japan
facility: Oita University Fuculty of Medicine
state: Oita
city: Okayama,Ifukucho,1-17-18
country: Japan
facility: Okayama Saiseikai General Hospital
state: Okayama
city: Minoh,Kayano,5-7-1
country: Japan
facility: Minoh City Hospital
state: Osaka
city: Osaka,Chuo-ku,Hoenzaka,2-1-14
country: Japan
facility: Osaka National Hospital
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Sakai,Minamiyasuicho,1-1-1
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Suita,Yamada-oka,2-2
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Takatsuki,Daigakucho,2-7
country: Japan
facility: Osaka Medical College
state: Osaka
city: Saitama,Omiya-ku,Amanuma-cho,1-847
country: Japan
facility: Omiya Medical Center, Jichi Medical School
state: Saitama
city: Tokorozawa,Namiki,3-2
country: Japan
facility: National Defense Medical College
state: Saitama
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Bunkyo-ku,Yushima,1-5-45
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chuo-ku,Tsukiji, 5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Meguro-ku,Ohashi,2-17-6
country: Japan
facility: Toho University Ohashi Hospital
state: Tokyo
city: Minato-ku,Toranomon,2-2-2
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Mitaka,Shinkawa,6-20-2
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Shinjuku-ku,Nishi-shinjuku,6-7-1
country: Japan
facility: Tokyo Medical University
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: National Cancer Center Hospital
name: Shin Fujita, MD
role: STUDY_CHAIR
References:
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.
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.
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.