Proton Radiotherapy Compared With Standard Radiotherapy for Head and Neck Squamous Cell Cancer
Compares proton and photon radiotherapy in people with head and neck squamous cell cancer.
Plain-language title generated from the registry record
Registry title: Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
Key facts
- Where
- Bergen, Oslo, Tromsø, and Trondheim, NorwaySee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 90 years old?
Source: NCT07580300, who can take part
Where in Norway
- Haukeland University HospitalBergen, NorwayNot yet recruiting
- Oslo University Hospital - RadiumhospitaletOslo, NorwayTaking people
- University Hospital of Northern NorwayTromsø, NorwayNot yet recruiting
- St Olavs HospitalTrondheim, NorwayNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT07580300
- Record updated
- 15 May 2026
- Original description
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.Read full original descriptionShow less
PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.
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.
Inclusion: Signed informed consent; Age ≥ 40 years; Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx; Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin); ECOG performance status 0-2; Ability to fill in patient questionnaires and comply with study procedures; Able to answer questionnaires in Norwegian or English; Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm.
Exclusion: Previous radiotherapy to the head and neck; Glottic cancers, cT1-T2 cN0 cM0; Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas; Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer; Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could, at the investigator's opinion, interfere with the participant's safety or study participation; Distant metastasis; Patients with pacemakers and/or implanted defibrillators; Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).