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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Procedure: Mesorectal excision with lateral lymph node dissection
* Procedure: Mesorectal excision without lateral lymph node excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Procedure/Surgery: Mesorectal excision with lateral lymph node dissection | Procedure: Mesorectal excision with lateral lymph node dissection<br>* Mesorectal excision with lateral lymph node dissection<br>|
| Experimental: 2<br>Procedure/Surgery: Mesorectal excision without lateral lymph node excision | Procedure: Mesorectal excision without lateral lymph node excision<br>* Mesorectal excision without lateral lymph node excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  | Until relapsing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Overall | 
| 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 | 
| Incidence of sexual and urinary dysfunction |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Cancer, Lymph Node Dissection, Rectal Surgery, Autonomic Nerves, Stage II, III lower rectal cancer