Randomized Study Comparing Sentinel Lymph Node Biopsy to Standard Neck Dissection for Early-Stage Oral Cavity Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating how sentinel lymph node SLN biopsy surgery compares to standard elective neck dissection END in treating patients with early-stage oral cavity squamous cell carcinoma OCSCC. This phase IIIII trial focuses on patient-reported neck and shoulder function, quality of life, and disease-free survival to determine if SLN biopsy works better or at least as well as the standard surgery while potentially causing less impairment. Participants are randomly assigned to one of two groups. One group receives an imaging agent injection followed by planar imaging and SPECTCT scans over 1 to 2 hours, then undergoes SLN biopsy surgery. The other group undergoes the standard neck dissection surgery. Both groups have FDG PETCT, CT, andor chest x-rays at screening and during follow-up. The trial includes detailed assessments of surgical outcomes, complications, and diagnostic imaging performance. Participants complete patient-reported outcome questionnaires on neck and shoulder function and quality of life before surgery, and at intervals up to 12 months after surgery. Imaging tests and chest x-rays are done at screening and during follow-up visits scheduled at 3 weeks post-surgery, then every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and annually thereafter. Researchers measure disease-free survival, overall survival, treatment toxicity, and hospital stay length over an extended follow-up of up to 11 years.

Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer