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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
Cervical lymph node metastasis is the most important prognostic factor in oral cavitysquamous cell carcinoma (OCSCC). Surgical management of the neck is an integral componentof treatment; however, the optimal extent of neck dissection for patients with clinicallynode‐positive (cN1) disease remains uncertain. Although modified neck dissection (levelsI‐V with preservation of non‐lymphatic structures) has traditionally been recommended fornode‐positive disease, several retrospective studies have suggested that carefullyselected patients with limited nodal disease may achieve comparable regional control witha less extensive selective neck dissection. Nevertheless, these studies are subject toselection bias, and no adequately powered randomized controlled trial has directlycompared these surgical approaches.Dissection of lower cervical nodal levels may increase operative time and postoperativemorbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairmentin quality of life. Reducing the extent of neck dissection without compromising oncologicoutcomes could improve postoperative functional recovery and patient‐reported outcomeswhile maintaining regional disease control.The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neckdissection (levels I‐IV) with modified neck dissection (levels I‐V) in patients withresectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the studyincorporates validated functional and quality‐of‐life assessments to comprehensivelyevaluate the impact of the two surgical strategies. Participants will receive standardtreatment for the primary tumor, and adjuvant therapy will be administered according tofinal histopathological findings and contemporary treatment guidelines.The findings of this trial are expected to provide high‐level evidence to guide thesurgical management of the clinically N1 neck in OCSCC. If selective neck dissectiondemonstrates equivalent oncologic outcomes with lower morbidity, it may support a changein surgical practice by reducing unnecessary treatment while preserving function andquality of life.
Epistemonikos ID: ba48cc2cb50bb36ba81f3a4149c34aac96a788c8
First added on: Jul 22, 2026