Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.

A national, randomized, clinical trial (phase III) investigating radiotherapy with protons compared with photons for patients with squamous cell carcinoma of the head and neck area eligible for radiotherapy, either radical or postoperative, with curative intent. Comparative dose plans with protons and photons will be prepared, and the probability of toxicity evaluated with NTCP models. Patients with presumed benefit from protons will be randomized 1:1 to treatment with protons or photons. The number of randomized participants will be 400. The primary endpoint is "combined toxicity burden" - dry mouth, difficulty swallowing, pain and affected speech in the period after the end of radiotherapy to 12 months after treatment.

NCT Number	NCT07580300
Lead Sponsor	Oslo University Hospital Collaborators: Klinbeforsk, South-Eastern Norway Regional Health Authority
Conditions	HNSCC
Enrollment	400 participants
Start Date	2026-04-28
Primary Completion	2030-04-28 (estimated)
Study Completion	2055-04-28 (estimated)
Updated on ClinicalTrials.gov	2026-05-15