Status:
COMPLETED
Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
21-74 years
Phase:
PHASE3
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 clin...
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 ly...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00190541
Start Date
June 1 2003
End Date
June 1 2015
Last Update
September 22 2016
Active Locations (48)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan, 470-1192
3
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
4
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577