Personalized Neck Radiation Based on Sentinel Lymph Node Biopsy for Oropharynx, Larynx, and Hypopharynx Squamous Cell Carcinoma Compared to Standard Bilateral Neck Radiation

What this Trial Is About

Researchers are evaluating a personalized approach to elective neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. This study compares this method to the standard bilateral elective neck irradiation in patients who need such treatment. The goal is to reduce unnecessary radiation to normal tissues, potentially lowering long-term side effects like dry mouth and difficulty swallowing, thus improving quality of life. The trial involves two groups one group will undergo a sentinel lymph node biopsy to determine the extent of neck irradiation needed. Depending on biopsy results, patients may receive no elective neck irradiation, unilateral, or bilateral neck irradiation along with radiotherapy to the primary tumor. The other group will receive the standard bilateral elective neck irradiation without biopsy. The study tracks outcomes over two years. Participants will be monitored through imaging, histopathological examination of lymph nodes, and patient-reported quality of life questionnaires focusing on xerostomia symptoms. Researchers will assess safety by tracking regional lymph node recurrence within two years and effectiveness by measuring quality of life at six months. Additional assessments include radiation toxicity, survival rates, and cost-effectiveness, with total follow-up lasting two years after treatment.

Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.