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NCT00190541 Clinical Trial

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

Rectal Neoplasms Clinical Trial

Official title:
Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190541
Other study ID # JCOG0212
Secondary ID C000000034
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated September 20, 2016
Start date June 2003
Est. completion date June 2015

Study information
Verified date September 2016
Source Japan Clinical Oncology Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical 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

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 information / eligibility
Status Completed
Enrollment 700
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 74 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Mesorectal excision with lateral lymph node dissection
Mesorectal excision with lateral lymph node dissection
• Mesorectal excision without lateral lymph node excision
Mesorectal excision without lateral lymph node excision

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

Sponsors (2)
Lead Sponsor Collaborator
Haruhiko Fukuda Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relapse-free survival Until relapsing No
Secondary Overall survival Overall No
Secondary Local-recurrence-free survival Until local-recurrence No
Secondary Incidence of adverse events 5 years Yes
Secondary Incidence of major adverse events 5 years Yes
Secondary Operative time Operation day Yes
Secondary Blood loss Operation day Yes
Secondary Incidence of sexual and urinary dysfunction 1 year Yes
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