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

Recruiting now · Not applicable

Conditions studied: Oral Cavity Squamous Cell Carcinoma

In brief

Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking. The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm. The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities. This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.

Key facts

Study ID

NCT07717307

Run by

Kolhapur Cancer Centre - Cancer Centers of America

People needed

80

Starts

2026-08-01

Expected to finish

2031-04-23

Last updated by the study team

2026-08-04

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kolhapur Cancer Centre — Kolhāpur, Maharashtra, India (enrolling)

Full record on ClinicalTrials.gov

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