A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are investigating the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have achieved a complete pathological response (pCR) after cervical lymph node surgery combined with neoadjuvant chemotherapy and immunotherapy. This prospective phase II clinical trial aims to explore whether reducing postoperative radiotherapy can better protect normal tissues such as the pharyngeal constrictor muscles, thyroid, parotid glands, and submandibular glands without compromising tumor control or interfering with immunotherapy effectiveness. All participants receive intensity-modulated conformal radiotherapy (IMRT) following strict quality and target volume guidelines. The radiation targets include the tumor bed and high-risk and low-risk clinical target volumes, carefully delineated based on imaging and clinical assessments before and after induction therapy. Radiotherapy plans are reviewed by the research team to ensure adherence to consensus guidelines. This approach focuses on reducing radiotherapy doses in low-risk areas to minimize harm to normal tissues. Participants will be monitored for two years to assess outcomes including region-free recurrence survival, progression-free survival, distant metastasis-free survival, overall survival, and local recurrence-free survival. Quality of life is assessed regularly from baseline through two years post-treatment using questionnaires. Radiation-related injuries are tracked from the start of radiotherapy through the two-year follow-up. The study involves detailed clinical and laboratory evaluations to ensure safety and measure treatment effects over time.

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma