Personalized Reduced Radiation Volume in Elective Nodal Irradiation for Oropharyngeal Squamous Cell Carcinoma A Phase 2 Study on Safety of Treatment Volume Reduction to Lower Toxicity

What this Trial Is About

Researchers are evaluating a personalized approach to reduce the size of the elective clinical target volume CTV in radiotherapy for patients with oropharyngeal squamous cell carcinoma SCC of all stages. This study aims to reduce treatment-related toxicity by tailoring radiation volumes based on individual risk factors and disease progression, using a model-based de-escalation strategy. The goal is to assess the feasibility and safety of this approach by monitoring out-of-field nodal recurrences. The treatment involves a personalized reduction of the elective nodal irradiation volume guided by a statistical model of lymphatic tumor progression developed from a large dataset of patients. This model estimates the probability of occult lymph node metastases based on clinical information such as tumor stage and lymph node involvement. The reduced radiation volumes are carefully reviewed by investigators to ensure consistency with clinical judgment and data. The study focuses on primary radiotherapy or chemoradiotherapy with elective lymph node irradiation. Participants will be monitored for up to two years after completing radiotherapy to track nodal recurrence outside the treated areas. Assessments include imaging scans like FDG-PET or MRI before treatment, physical exams, and evaluations of treatment toxicity and quality of life at various time points up to 24 months post-treatment. The study measures both early and late toxicities, loco-regional control, progression-free survival, overall survival, and quality of life related to head and neck symptoms to determine the safety and impact of this personalized radiation approach.

Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma