Comparing Neck Observation and Elective Neck Dissection in Adults with Early-Stage Oral Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the clinical outcomes in patients with cT1N0M0 oral squamous cell carcinoma OSCC who receive either primary lesion resection combined with elective neck dissection or primary lesion resection only. The study aims to compare the 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life between these two approaches. The trial involves 300 patients, divided equally between the two treatment groups, to provide insight into the benefits and risks of neck management strategies in OSCC. Participants in the experimental arm will undergo radical resection of the primary lesion only, with neck observation, maintaining safety margins of 1.0-1.5 cm from the lesions palpable edges. The control arm will receive radical resection of the primary lesion with similar safety margins plus elective neck dissection during the same surgery. Both groups will have lesion detection performed using ultrasonography, CT scan, andor MRI. Follow-up visits will be conducted every two months for at least two years, focusing on lymph node metastasis and local recurrence. During the study, patients will have a complete medical history taken and tumor assessment at baseline. Follow-ups will occur every three months for the first two years, every six months for the next 3 to 5 years, and annually thereafter until death or data censoring. Researchers will collect and analyze data on lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life over two years. Continuous monitoring with imaging and clinical evaluations will support this comprehensive assessment of patient outcomes.

Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC