Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)
- Conditions
- Rectal Neoplasms
- Interventions
- Procedure: Mesorectal excision with lateral lymph node dissectionProcedure: Mesorectal excision without lateral lymph node excision
- Registration Number
- NCT00190541
- Lead Sponsor
- Haruhiko Fukuda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Mesorectal excision with lateral lymph node dissection Procedure/Surgery: Mesorectal excision with lateral lymph node dissection 2 Mesorectal excision without lateral lymph node excision Procedure/Surgery: Mesorectal excision without lateral lymph node excision
- Primary Outcome Measures
Name Time Method Relapse-free survival Until relapsing
- Secondary Outcome Measures
Name Time Method Local-recurrence-free survival Until local-recurrence Incidence of adverse events 5 years Incidence of major adverse events 5 years Operative time Operation day Blood loss Operation day Overall survival Overall Incidence of sexual and urinary dysfunction 1 year
Trial Locations
- Locations (48)
Hiroshima City Hospital
🇯🇵Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan
Fujita Health University
🇯🇵Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
Chiba Cancer Center Hospital
🇯🇵Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
Jyuntendo Urayasu Hospital
🇯🇵Urayasu,Tomioka,2-1-1, Chiba, Japan
Toho University Sakura Hospital
🇯🇵Sakura,Shimoshidu,564-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
Kurume University School of Medicine
🇯🇵Kurume,Asahi-machi,67, Fukuoka, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
Kurume University Medical Center
🇯🇵Kurume,Kokubumachi,155-1, Fukuoka, Japan
Hiroshima University, School of Medicine
🇯🇵Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan
Sapporo-Kosei General Hospital
🇯🇵North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
🇯🇵Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki,Inabasou,3-1-69, Hyogo, Japan
Ishikawa Prefectual Central Hospital
🇯🇵Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan
Kitasato University School of Medichine
🇯🇵Sagamihara,Kitasato,1-15-1, Kanagawa, Japan
Teikyo University Hospital, Mizonokuchi
🇯🇵Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan
Kitasato University East Hospital
🇯🇵Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan
National Hospital Organization Kyoto Medical Center
🇯🇵Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan
Kanagawa Cancer Center
🇯🇵Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Showa University Northern Yokohama Hospital
🇯🇵Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan
Yokohama City University Medical Center
🇯🇵Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, Japan
Miyagi Cancer Center
🇯🇵Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
Nagano Municipal Hospital
🇯🇵Nagano,Tomitake,1333-1, Nagano, Japan
Oita University Fuculty of Medicine
🇯🇵Oita,Hasama-machi,Oogaoka,1-1, Oita, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Okayama Saiseikai General Hospital
🇯🇵Okayama,Ifukucho,1-17-18, Okayama, Japan
Minoh City Hospital
🇯🇵Minoh,Kayano,5-7-1, Osaka, Japan
Osaka National Hospital
🇯🇵Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan
Sakai Municipal Hospital
🇯🇵Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Osaka University Graduate School of Medicine
🇯🇵Suita,Yamada-oka,2-2, Osaka, Japan
Osaka City General Hospital
🇯🇵Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Osaka Medical College
🇯🇵Takatsuki,Daigakucho,2-7, Osaka, Japan
Omiya Medical Center, Jichi Medical School
🇯🇵Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan
Sizuoka Cancer Center
🇯🇵Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan
National Defense Medical College
🇯🇵Tokorozawa,Namiki,3-2, Saitama, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya,Yohnan,4-9-13, Tochigi, Japan
Toho University Ohashi Hospital
🇯🇵Meguro-ku,Ohashi,2-17-6, Tokyo, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji, 5-1-1, Tokyo, Japan
Toranomon Hospital
🇯🇵Minato-ku,Toranomon,2-2-2, Tokyo, Japan
Kyorin University School of Medicine
🇯🇵Mitaka,Shinkawa,6-20-2, Tokyo, Japan
Tokyo Medical University
🇯🇵Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku,Shinanomachi,35, Tokyo, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata,Aoyagi,1800, Yamagata, Japan