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Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
Sponsor: Oslo University Hospital
Summary
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.
Official title: PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.
Key Details
Gender
All
Age Range
40 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-04-28
Completion Date
2055-04-28
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
Proton Radiotherapy
Proton versus Photon
Locations (4)
Haukeland University Hospital
Bergen, Norway
Oslo University Hospital, Radiumhospitalet
Oslo, Norway
University Hospital of Northern Norway
Tromsø, Norway
St. Olavs Hospital
Trondheim, Norway