anorec study: Lateral Nodal Recurrence in rectal Cancer

Completed

Conditions: Lateral lymph node recurrence in rectal cancer
metastasised rectal cancer
10017990
10017991
10017998

Registration Number: NL-OMON52811

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 145

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- patients with rectal cancer
- at least one enlarged lateral node; with a short-axis of *7mm on the iliac or
obturator compartment, measured on MRI

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Patients younger than 18 years old
- Patients with previous pelvic radiotherapy
- Patients that have undergone a lateral lymph node dissection for a previous
pelvic malignancy
- Patients with synchronous distant metastases
- Synchronous colon cancer with a higher stage than the rectal cancer
- Other malignancies in the previous 3 years which could affect oncological
outcomes (these patients must first be discussed with the research team before
inclusion)
- Patients with an absolute contra-indication for general anaesthesia
- Patients with familiar adenomatous polyposis (FAP)
- Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate whether optimal irradiation and indicated lateral lymph node<br /><br>dissections (LLNDs) can reduce the lateral local recurrence rate to 6%, as<br /><br>described in the literature. Patients who cannot undergo nerve sparing LLND or<br /><br>minimally invasive TME due to the extensiveness of their tumor will drop out of<br /><br>the main cohort and enter the registration arm together with Asian patients<br /><br>treated in Asia who follow the exact same protocol. </p><br>

Secondary Outcome Measures