Clinical Trials Directory

Trials / Completed

CompletedNCT00190541

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
700 (actual)
Sponsor
Haruhiko Fukuda · Academic / Other
Sex
All
Age
21 Years – 74 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMesorectal excision with lateral lymph node dissectionMesorectal excision with lateral lymph node dissection
PROCEDUREMesorectal excision without lateral lymph node excisionMesorectal excision without lateral lymph node excision

Timeline

Start date
2003-06-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2005-09-19
Last updated
2016-09-22

Locations

48 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT00190541. Inclusion in this directory is not an endorsement.