Comparing Limited and Extensive Neck Surgery for Clinically N1 Oral Cavity Squamous Cell Carcinoma Evaluating Survival and Quality of Life

What this Trial Is About

This research aims to compare two surgical approaches for patients with oral cavity squamous cell carcinoma OCSCC who have cancer spread to neck lymph nodes clinically node-positive, cN1. The trial evaluates whether a less extensive selective neck dissection levels I-IV provides outcomes comparable to a more extensive modified neck dissection levels I-V while reducing surgical complications. The study addresses the uncertainty around the best extent of neck surgery to balance cancer control with quality of life. Participants will be randomly assigned to one of two groups selective neck dissection removing lymph node levels I-IV, or modified neck dissection removing levels I-V while preserving key nerves and muscles when possible. Both groups will also receive surgical removal of the primary oral tumor, with reconstruction and additional treatments based on pathology results and standard care. This trial will provide high-quality evidence comparing these two surgical techniques. During the study, participants will undergo assessments of regional cancer recurrence over three years, quality of life using the Neck Dissection Impairment Index, and shoulder function at multiple time points up to two years after surgery. Other measures include overall survival, disease-free survival, nodal involvement analysis, and monitoring of surgical complications such as chyle leak. The total follow-up period extends up to three years to evaluate long-term outcomes and function.

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