A phase III multicenter randomized non-inferiority trial comparing selective versus modified neck dissection in node-positive oral squamous cell carcinoma (SND vs MND).

Abstract

TPS6133 Background: Neck dissection is a critical component in the management of oral squamous cell carcinoma (OSCC) with nodal involvement. While modified neck dissection (MND) is widely practised in node-positive disease, selective neck dissection (SND) may offer comparable oncologic outcomes with reduced morbidity. Retrospective studies and meta-analyses suggest similar survival and regional control with SND in selected patients; however, high-quality prospective randomized evidence is lacking. This trial aims to evaluate whether SND is non-inferior to MND in terms of disease-free survival in treatment-naïve, node-positive OSCC patients. Methods: This is a prospective, multicenter, randomized, non-inferiority controlled trial enrolling patients aged 18–70 years with clinically and radiologically confirmed node-positive OSCC (T1–T4, N+), ECOG performance status 0–1, and adequate organ function. Eligible participants are randomized 1:1 to undergo primary tumor resection with either selective neck dissection (Arm A) or modified neck dissection (Arm B). Adjuvant radiotherapy or chemoradiotherapy is administered according to adverse pathological features, including extracapsular extension and positive margins. Randomization is stratified by participating centres. The planned accrual period is 3 years, followed by 2 years of follow-up. The study is conducted at four tertiary cancer centres in India. The primary endpoint is disease-free survival. Secondary endpoints include overall survival, regional recurrence rate, treatment-related morbidity, and quality of life assessed using EORTC QLQ-C30 and QLQ-H&N35 questionnaires. Statistical Considerations: Assuming a 24-month DFS of 85% in the MND arm and a non-inferiority margin of 10%, a total of 432 patients (216 per arm) provides 80% power with a one-sided alpha of 0.05. Non-inferiority will be concluded if the upper bound of the 90% confidence interval for the hazard ratio is less than 1.5. Survival analyses will be performed using Kaplan–Meier methods and Cox proportional hazards models. The study has received institutional ethics approvals at participating centres and is registered with the Clinical Trials Registry of India. Patient recruitment is ongoing. This trial will provide prospective evidence regarding the oncologic equivalence of selective and modified neck dissection in node-positive OSCC and may help define a less morbid standard surgical approach. This trial will provide prospective evidence regarding the oncologic equivalence of selective and modified neck dissection in node-positive OSCC and may help define a less morbid standard surgical approach. Clinical trial information: CTRI/2024/11/076784.