A randomized Phase III trial of thoracoscopic versus open esophagectomy for thoracic esophageal cancer: Japan Clinical Oncology Group Study JCOG1409

Jpn J Clin Oncol. 2016 Feb;46(2):174-7. doi: 10.1093/jjco/hyv178. Epub 2016 Jan 4.

Abstract

A randomized Phase III study was commenced in May 2015 to confirm the non-inferiority of thoracoscopic esophagectomy to open esophagectomy in terms of overall survival for clinical Stage I-III esophageal cancer. A total of 300 patients will be accrued from Japanese institutions over 6 years. The primary endpoint is overall survival. The secondary endpoints are relapse-free survival, proportion of patients with R0 resection, proportion of patients who underwent re-operation, adverse events, postoperative respiratory function change, postoperative quality-of-life score (EORTC QLQ-C30), and proportion of patients who need conversion from thoracoscopic surgery to open surgery. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017628.

Keywords: Phase III; open esophagectomy; thoracoscopic esophagectomy.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Disease-Free Survival
  • Esophageal Neoplasms / pathology
  • Esophageal Neoplasms / surgery*
  • Esophagectomy / adverse effects
  • Esophagectomy / methods*
  • Female
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / surgery*
  • Neoplasm Staging
  • Patient Selection
  • Postoperative Period
  • Quality of Life
  • Respiration
  • Thoracoscopy*
  • Treatment Outcome