Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread

Cervical lymph node metastasis is the most important prognostic factor in oral cavity squamous cell carcinoma (OCSCC). Surgical management of the neck is an integral component of treatment; however, the optimal extent of neck dissection for patients with clinically node-positive (cN1) disease remains uncertain. Although modified neck dissection (levels I-V with preservation of non-lymphatic structures) has traditionally been recommended for node-positive disease, several retrospective studies have suggested that carefully selected patients with limited nodal disease may achieve comparable regional control with a less extensive selective neck dissection. Nevertheless, these studies are subject to selection bias, and no adequately powered randomized controlled trial has directly compared these surgical approaches.

Dissection of lower cervical nodal levels may increase operative time and postoperative morbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairment in quality of life. Reducing the extent of neck dissection without compromising oncologic outcomes could improve postoperative functional recovery and patient-reported outcomes while maintaining regional disease control.

The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neck dissection (levels I-IV) with modified neck dissection (levels I-V) in patients with resectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the study incorporates validated functional and quality-of-life assessments to comprehensively evaluate the impact of the two surgical strategies. Participants will receive standard treatment for the primary tumor, and adjuvant therapy will be administered according to final histopathological findings and contemporary treatment guidelines.

The findings of this trial are expected to provide high-level evidence to guide the surgical management of the clinically N1 neck in OCSCC. If selective neck dissection demonstrates equivalent oncologic outcomes with lower morbidity, it may support a change in surgical practice by reducing unnecessary treatment while preserving function and quality of life.

Inclusion criteria

• Histologically proven squamous cell carcinoma of oral cavity will be included
• Clinical stage T1-T4, N1, M0
• cN1 neck on clinical examination and imaging (CT/MRI)
• Single node which is FNAC proven without any other significant nodes.
• Patients with ASA grade II and I.
• Understands the protocol and able to give informed consent.

Exclusion criteria

• Recurrent cases
• Multiple significant nodes
• Nodes clinical/radiological with ENE
• Single metastatic node at level III/IV/V
• Single metastatic node with other suspicious nodes
• Patients with a history of head and neck radiation therapy treatment
• Previous history of any malignancy