Personalized Neck Radiation Therapy Guided by Sentinel Lymph Node Biopsy for Treating Oral Cavity Squamous Cell Carcinoma in a Phase II Trial

What this Trial Is About

Researchers are evaluating personalized neck radiation therapy guided by sentinel lymph node biopsy SLNB in patients with oral cavity squamous cell carcinoma OCSCC. The study aims to determine if SLNB can help direct radiation therapy to one side of the neck instead of both, potentially reducing side effects such as dry mouth, speech and swallowing difficulties, radiation-induced cancers, and chronic pain. This phase II trial investigates whether sparing the opposite side of the neck from radiation is safe and effective in controlling cancer spread. Participants will undergo SLNB as part of their standard care, where a radiotracer is injected around the tumor to identify sentinel lymph nodes that may contain cancer cells. Based on SLNB results, radiation therapy will be personalized to target either one side or both sides of the neck. Additional treatments may include chemotherapy drugs like carboplatin, cisplatin, and paclitaxel given intravenously. Various procedures such as CT scans, PET-CT, SPECT-CT, and swallow studies will be conducted to support diagnosis and treatment planning. During the study, participants will be closely monitored through imaging, blood sample collection, and questionnaires to assess quality of life, neck function, oral dryness, and cancer recurrence. The main outcome measured is the control of cancer in the opposite side of the neck one year after treatment. Secondary outcomes include survival rates and changes in quality of life and swallowing function. Participants will be followed for assessments up to one year after completing treatment to evaluate safety and effectiveness.

Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial