A Prospective, Multicentric, Non inferiority Randomized Controlled Trial Comparing Outcomes of Selective Neck Dissection versus Modified Neck Dissection in Treatment-Naive, Node-Positive Oral Squamous Cell Carcinoma.

Title :

A Prospective, Multicentric, Non inferiority Randomized Controlled Trial Comparing Outcomes of Selective Neck Dissection versus Modified Neck Dissection in Treatment-Naive, Node-Positive Oral Squamous Cell Carcinoma.

Rationale :

This study aims to bridge the gap in literature by conducting a multicentric, prospective, randomized controlled trial comparing the outcomes of SND versus MND in treatment-naive patients with node-positive OSCC. The primary endpoint will be disease-free survival (DFS), defined as the time from surgery to the first recurrence (local, regional, or distant) or death from any cause, with secondary endpoints including regional recurrence rates, overall survival (OS), treatment-related morbidity, and Quality of Life (QoL).

Primary Objective: To evaluate and compare disease-free survival (DFS) between patients undergoing selective neck dissection (SND) and those undergoing modified neck dissection (MND) for node-positive oral squamous cell carcinoma.Secondary Objectives:

1. To compare the regional recurrence rates associated with each surgical intervention.
2. To assess overall survival (OS) between the two treatment arms.
3. To evaluate treatment-related morbidity, including functional outcomes.
4. To assess the impact on quality of life (QoL) using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.

Study Design :

This study is structured as a multicentric, prospective, randomized controlled trial (RCT) targeting treatment-naive patients with radiologically confirmed, node-positive oral squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to receive either selective neck dissection (SND) or modified neck dissection (MND).

Study Duration:

5 years (3 years of patient accrual and 2 years of follow-up).

Study setting :The trial will be conducted at the following study sites:

1. Tieten Medicity, Kasarvadavali, Thane
2. Jaslok Hospital**,**Mumbai
3. Bombay Hospital,Mumbai
4. P.D. Hinduja Hospital, Khar,Mumbai

Sample Size:

A total of 432 patients, 216 patients in each arm, randomized in 1:1 manner will be required for the completion of the study.

Ethics and Regulatory Compliance:This study will be conducted in full compliance with;

1. ICH-GCP guidelines, ensuring that the rights, safety, and well-being of the study participants are protected.
2. NDCT 2019 regulations, ensuring that the study complies with all Indian regulatory requirements for clinical trials.
3. Ethical approval is obtained from institutional ethics committees at all participating centers before patient recruitment. The trial will be registered with the Clinical Trials Registry of India (CTRI) as required by NDCT 2019 .