A phase II randomized study of proton therapy vs intensity-modulated radiation therapy in patients with unilateral head and neck cancer.

The primary endpoint was clinician-reported acute grade ≥2 oral mucositis through 3 months after radiotherapy.

Rates of grade ≥3 dermatitis and grade ≥2 dysphagia were similar between groups, and late toxicities were uncommon with no grade 3 events.

Patient-reported outcomes mirrored these findings, although confidence intervals were wide.

Three-year local control, progression-free survival, and overall survival were high and were no different between arms.