title: 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.
abstract: 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.
  
  
  
  This 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.
  
  
  
  This 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.
  
  
  
  This trial was registered at ClinicalTrials.gov (identifier NCT02614157 ) Registered on 24 November 2015.
authors.affiliation: Department of Gastrointestinal Surgery, State Key Laboratory of Biotherapy and Cancer Center/Collaborative Innovation Center for Biotherapy, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
authors.forename: Mingtian
authors.initials: M
authors.lastname: Wei
authors.affiliation: Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Guo Xue Xiang No.37, Chengdu, 610041, People's Republic of China.
authors.forename: Qingbin
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Gastrointestinal Surgery, State Key Laboratory of Biotherapy and Cancer Center/Collaborative Innovation Center for Biotherapy, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
authors.forename: Chuanwen
authors.initials: C
authors.lastname: Fan
authors.affiliation: State Key Laboratory of Biotherapy and Cancer Center/Collaborative Innovation Center for Biotherapy, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.affiliation: State Key Laboratory of Biotherapy and Cancer Center/Collaborative Innovation Center for Biotherapy, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
authors.forename: Xiangzheng
authors.initials: X
authors.lastname: Chen
authors.affiliation: Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Guo Xue Xiang No.37, Chengdu, 610041, People's Republic of China.
authors.forename: Zongguang
authors.initials: Z
authors.lastname: Zhou
authors.affiliation: State Key Laboratory of Biotherapy and Cancer Center/Collaborative Innovation Center for Biotherapy, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China. hjunhong@hotmail.com.
authors.forename: Junhong
authors.initials: J
authors.lastname: Han
authors.affiliation: Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Guo Xue Xiang No.37, Chengdu, 610041, People's Republic of China. wzqtrial@gmail.com.
authors.forename: Ziqiang
authors.initials: Z
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D002681:China; D002985:Clinical Protocols; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008197:Lymph Node Excision / Q000009:adverse effects / Q000379:methods*; D008198:Lymph Nodes / Q000473:pathology / Q000601:surgery*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Lateral lymph node dissection; Neoadjuvant chemo-radiation; Rectal cancer; Recurrence; Total mesorectal excision