A multicenter randomized controlled trial of esophagectomy with or without prophylactic supraclavicular node dissection: a phase 3 trial (JCOG2013, MODERN3)

Abstract

Abstract The need for prophylactic supraclavicular lymph node dissection during esophagectomy with radical lymphadenectomy remains controversial. A randomized phase III trial was launched in August 2022 to confirm the non-inferiority of esophagectomy with D2 lymphadenectomy except for supraclavicular lymph node dissection to standard D2 lymphadenectomy in terms of overall survival for patients with resectable upper or middle thoracic esophageal cancer. This study will enroll 480 patients from 54 Japanese institutions over 5 years. The primary endpoint includes overall survival, and the secondary endpoints include relapse-free survival, perioperative and late complication incidences, supraclavicular lymph node recurrence, salvage cervical treatment incidence, synchronous cervical and abdominal procedure proportion, operation time and the number of operating surgeons. This trial has been registered at the Japan Registry of Clinical Trials under study number jRCT1030220248.