A multicenter randomized phase III trial to evaluate the value of omission of elective neck dissection for T3-T4aN0 laryngeal cancer: JCOG2407 (JALNECK).

Total laryngectomy with paratracheal dissection and elective lateral neck dissection (ELND) is the standard surgical procedure for T3-T4aN0 laryngeal cancer. However, ELND is associated with increased surgical invasiveness, higher risk of postoperative complications, and long-term functional impairment. Although previous studies suggest that ELND omission may reduce postoperative complications, including pharyngocutaneous fistulas and deterioration in quality of life (QOL), its impact on prognosis remains controversial. Therefore, we designed a multicenter, randomized phase III trial (JCOG2407) to confirm the non-inferiority of total laryngectomy with paratracheal dissection alone compared to surgery including ELND for T3-T4aN0 laryngeal cancer. The primary endpoint is overall survival. The secondary endpoints include short-term outcomes, postoperative complications, functional assessments, and QOL. A total of 280 patients from 39 institutions will be enrolled over 5 years. This trial has been registered with the Japan Registry of Clinical Trials (study number: jRCT1030250729).