Prospective Randomized Study on Adaptive Radiotherapy in Head and Neck Tumor Patients (Pro- Head and Neck -ART, ProHEART)

What this Trial Is About

This research focuses on patients with newly diagnosed oropharyngeal and hypopharyngeal cancers, which are types of head and neck tumors. It evaluates adaptive radiotherapy (ART) compared to standard image-guided radiotherapy (IGRT) without online adaptation. The study aims to determine if ART, which adjusts radiation doses based on the patient's daily anatomy, can improve outcomes such as swallowing function and reduce side effects like dysphagia, which affects quality of life. Participants are randomly assigned to one of two groups: one receiving adaptive radiotherapy with daily dose adjustments by specialists, and the other receiving standard radiotherapy without such adaptation. This approach builds on previous findings suggesting that dysphagia-optimized intensity-modulated radiotherapy (IMRT) can improve swallowing compared to standard IMRT. The study is prospective and randomized, focusing on the potential benefits of ART in improving treatment precision and patient experience. During the study, patients will be monitored for several years, with assessments including the EORTC Common Toxicity Criteria adverse event scores and dysphagia scores from 2 months up to 5 years after treatment. Secondary outcomes include overall survival and progression-free survival over the same period. These evaluations help researchers understand the long-term effects and safety of adaptive radiotherapy. The total duration of participation may extend up to five years for follow-up assessments.

Adaptive Radiotherapy in Head and Neck Tumor Patients