Phase III Study Comparing Standard and Hyperfractionated Radiotherapy in Head and Neck Squamous Cell Carcinoma Patients with High-Risk Tumors

What this Trial Is About

Researchers are investigating ways to personalize treatment for patients with head and neck squamous cell carcinoma HNSCC, especially those with advanced disease who face a higher risk of treatment failure. This phase III study compares two radiotherapy approaches for patients intended for curative treatment the standard radiotherapy and a hyperfractionated radiotherapy HFX-RT with a higher total radiation dose. The study also aims to improve prognostic and predictive methods by including exploratory analyses such as MRI to evaluate tumor hypoxia, gene profiling, immune profiling, and imaging texture analyses during treatment and follow-up. Participants will be randomly assigned to either standard radiotherapy, which delivers 68.0 Gy in daily fractions of 2.0 Gy, or to hyperfractionated radiotherapy, which delivers 83.0 Gy in smaller doses twice daily 1.22 Gy per fraction over five days per week. The doses vary depending on the tumor volume and lymph node involvement. Patients with lower-risk tumors not eligible for randomization may still participate in the translational research parts of the study. During the study, participants will be closely monitored with regular follow-up visits every three months for two years, then every six months up to five years, focusing on local tumor control. Researchers will collect imaging data, conduct gene and protein analyses, and assess tumor response. The study evaluates treatment effects and tumor behavior over time to better understand and improve outcomes for head and neck cancer patients.

a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients