A multicenter randomized phase III trial of weekly cisplatin chemoradiotherapy versus radiotherapy in elderly patients with head and neck squamous cell carcinoma unfit for high-dose cisplatin: JCOG2405 (ELDER-WEEKLY).

Chemoradiotherapy (CRT) with high-dose cisplatin (100 mg/m2) is the standard treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). However, this regimen is often intolerable in elderly patients because of its toxicity, and the optimal treatment for those unfit for high-dose cisplatin remains unclear. CRT with weekly cisplatin (40 mg/m2) has been developed as a more tolerable alternative and has demonstrated comparable efficacy with reduced toxicity in several trials involving nonelderly patients. We therefore designed a multicenter, randomized phase III trial (JCOG2405) to confirm the superiority of CRT with weekly cisplatin over radiotherapy alone in patients aged ≥70 years with locally advanced SCCHN who are unfit for high-dose cisplatin. The primary endpoint is overall survival. A total of 250 patients from 59 institutions will be enrolled over 5 years. The trial has been registered in the Japan Registry of Clinical Trials (study number: jRCTs031250688).