NCT07580300RecruitingPhase 3
Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 6 May 2026
- Start date
- Apr 2026
- Primary completion date
- Apr 2030
- Lead sponsor
- Oslo University Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07580300
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From Apr 2026 to the primary completion date, Apr 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy to the head and neck.
Other illness
- 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.
Other
- Distant metastasis.
- Patients with pacemakers and/or implanted defibrillators.
- Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).
Who the study is looking for
- 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.
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Not yet recruiting |
| Oslo University Hospital - Radiumhospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| University Hospital of Northern Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Not yet recruiting |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.