Lateral pelvic lymph node dissection after neoadjuvant chemo-radiation for preoperative enlarged lateral nodes in advanced low rectal cancer: study protocol for a randomized controlled trial.

Junhong Han,Xiangzheng Chen,Qingbin Wu,Zongguang Zhou,Yan Li,Ziqiang Wang,Chuanwen Fan,Mingtian Wei

doi:10.1186/s13063-016-1695-4

Abstract

Background Lateral lymph node (LLN) metastasis is a major cause of local recurrence of advanced rectal cancer. Although there is much controversy between Western and Eastern countries on whether lateral pelvic lymph node dissection (LLND) or neoadjuvant chemo-radiation (nCRT) is preferable for the treatment of LLN metastases, existing retrospective cohorts mainly focus on all middle/low advanced rectal cancer patients, not the specific individuals with suspicion of LLN metastases. The aim of this trial is to assess the efficacy and safety of LLND for rectal cancer patients with suspicion of LLN metastases.MethodsThis prospective, multicenter, randomized controlled, single-blinded, phase III trial is designed to enroll 512 eligible patients with advanced rectal cancer and preoperative enlarged lateral lymph nodes. The population will be randomly assigned into the solely total mesorectal excision (TME) group or the TME + LLND group after eligible selection. The primary outcomes are to be 3-year local recurrence rate and 3-year disease-free survival, and the secondary outcomes include 3-year overall survival, 1-year sexual and urinary function, and perioperative outcomes.DiscussionThis is the first randomized trial to investigate the efficacy and safety of LLND for advanced low rectal cancer patients with suspicion of LLN metastases; the result is expected to provide new evidence for the treatment of LLN where there is suspicion of metastases in advanced rectal cancer patients.Trial registrationThis trial was registered at ClinicalTrials.gov (identifier NCT02614157) Registered on 24 November 2015.

Highlights

Lateral lymph node (LLN) metastasis is a major cause of local recurrence of advanced rectal cancer
Especially Japan, favor lateral pelvic lymph node dissection (LLND) following total mesorectal excision (TME) for the following reasons: (1) the incidence of LLN metastases reaches as high as 10–25%, and 27% of rectal cancer patients who undergo TME solely would develop local recurrence [13,14,15,16], (2) the efficacy of LLND equals that of resection of local lymph node metastases
Sample size and statistical analysis Our trial aims to demonstrate that LLND could decrease the 3-year local recurrence rate of low rectal cancer patients with suspicion of LLN metastases

Summary

Introduction

Lateral lymph node (LLN) metastasis is a major cause of local recurrence of advanced rectal cancer. There is much controversy between Western and Eastern countries on whether lateral pelvic lymph node dissection (LLND) or neoadjuvant chemo-radiation (nCRT) is preferable for the treatment of LLN metastases, existing retrospective cohorts mainly focus on all middle/low advanced rectal cancer patients, not the specific individuals with suspicion of LLN metastases. The aim of this trial is to assess the efficacy and safety of LLND for rectal cancer patients with suspicion of LLN metastases. A large cohort of 11,567 cases from Japan demonstrates that resection of metastatic iliac lymph nodes does not show any differences between TME in patients with clinical stage TxN2aM0, and resection of obturator and external iliac lymph nodes favors that of liver metastasis [11], and (3) Japanese guidelines for the treatment of colorectal cancer in 2014 still recommend that patients with stages II/ III rectal cancer below the peritoneal reflection undergo regular TME + LLND [17]

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