Phase II Randomized Study Comparing Radiotherapy and Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatments for patients with early-stage oropharyngeal squamous cell carcinoma that is HPV-negative. This randomized phase II trial compares two main treatment approaches standard radiotherapy with or without chemotherapy, and trans-oral surgery combined with neck dissection, sometimes followed by radiation. The study aims to assess which treatment offers better disease control and quality of life, as well as overall survival and side effects, to inform future larger trials. Participants are randomly assigned to one of two groups. One group receives the current standard care of radiation with or without chemotherapy. The other group undergoes trans-oral surgery plus neck dissection, with radiation added if necessary. Patients are stratified by tumor size and lymph node involvement to help ensure balanced comparison. Treatment is delivered under medical supervision with a plan to evaluate the outcomes over several years. During the study, participants will be closely monitored through regular check-ups for up to five years. Researchers will measure disease-specific survival, overall survival, progression-free survival, and treatment side effects. Quality of life will be assessed repeatedly from the start of treatment through follow-up. Additional measures include rates of feeding tube use and swallowing difficulties. The study includes regular assessments of toxicity and tumor control to understand the impact of each treatment approach over time.

Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma