Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)
21 Years
74 Years
Both
Rectal Neoplasms
Trial Information
Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relapse-free survival
Outcome Time Frame:
Until relapsing
Safety Issue:
No
Principal Investigator
Shin Fujita, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Center Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG0212
NCT ID:
NCT00190541
Start Date:
June 2003
Completion Date:
June 2015
Related Keywords:
- Rectal Neoplasms
- Rectal Cancer
- Lymph Node Dissection
- Rectal Surgery
- Autonomic Nerves
- Stage II, III lower rectal cancer
- Neoplasms
- Rectal Neoplasms
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