HNSCCPhase 3PRORADNOR-RCTNCT07580300
Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
A Phase 3 study testing Proton Radiotherapy in people with HNSCC, run by Oslo University Hospital at 4 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- HNSCC
- What is being tested?
- Proton Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesNorway
- Study dates
- 28 Apr 2026to 28 Apr 2055
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Glottic cancers, cT1-T2 cN0 cM0.
- Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas.
- Distant metastasis.
- Previous radiotherapy to the head and neck.
- Patients with pacemakers and/or implanted defibrillators.
- Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer.
- Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway4 sites, 4 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen, 5051
Jon Espen Dale, MD PhD, 004755975000, jon.espen.dale@helse-bergen.no
Jon Espen Dale, MD PhD
- Recruiting
Oslo University Hospital, Radiumhospitalet
Oslo, 0379
Hanne Eide, MD PhD, 004722934000, haeid@ous-hf.no
Hanne Eide, MD PhD
- Not yet recruiting
University Hospital of Northern Norway
Tromsø, 9038
Thomas K. Kilvær, MD Associate prof., 004777626000, Thomas.Kilvaer@unn.no
Thomas Kilvær, MD Associate prof.
- Not yet recruiting
St. Olavs Hospital
Trondheim, 7006
Mirjam Alsaker, MD PhD, 004772573000, Mirjam.Delange.Alsaker@stolav.no
Mirjam Alsaker, MD PhD
About this study
Official title: 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.
- Conditions
- HNSCC
- Being tested
- Proton Radiotherapy
- Keywords
- HNSCC, Proton
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton RadiotherapyRadiation
Proton versus Photon
| Study group | Role | What they receive |
|---|---|---|
| Proton, Radiotherapy | Experimental | Not described Receives: Radiation: Proton Radiotherapy |
| Photon, Radiotherapy | Active comparator | Not described Receives: Radiation: Proton Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The combined burden of patient-reported dysphagia, xerostomia, pain and speech measured as the area under the curve (AUC) with EORTC QLQ-H&N43 at baseline, end of treatment, 3-, 6- and 12-months following radiotherapy.
Measured: 12 Months
Secondary outcomes (5)
Time from date of randomisation to date of loco-regional failure, distant metastasis or death from all causes, whichever comes first.
Measured: 10 Years
Occurrence of at least one event grade 2 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 3 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 4 toxicity as defined by CTCAE v5.0.
Measured: 12 Months
Time from date of randomisation to date of death (all causes).
Measured: 10 Years
The combined toxicity burden of dysphagia, xerostomia, pain and speech measured with QLQ-H&N43 5 years after treatment.
Toxicity burden measured with QLQ-H\&N43
Measured: 5 Years
Time from date of randomisation to the first documented loco-regional failure.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start28 Apr 2026
- Primary completion28 Apr 2030 (estimated)
- Study completion28 Apr 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant randomized 1:1 to treatment with proton or photon radiotherapy
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Klinbeforsk, South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Hanne Astrid Eide, Oslo University Hospital
- Investigators
- Hanne Eide, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580300
- Sponsor's protocol ID
- 912158
- Acronym
- PRORADNOR-RCT
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.
- ClinicalTrials.gov ID
- NCT07580300
- Acronym / sponsor ID
- PRORADNOR-RCT / 912158
- Conditions
- HNSCC
- Keywords
- HNSCC, Proton
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Klinbeforsk, South-Eastern Norway Regional Health Authority
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 28 Apr 2030 (estimated)
- Study completion
- 28 Apr 2055 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participant randomized 1:1 to treatment with proton or photon radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Proton, Radiotherapy | Experimental | Radiation: Proton Radiotherapy |
| Photon, Radiotherapy | Active comparator | Radiation: Proton Radiotherapy |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- Glottic cancers, cT1-T2 cN0 cM0.
- Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas.
- Distant metastasis.
- Previous radiotherapy to the head and neck.
- Patients with pacemakers and/or implanted defibrillators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton RadiotherapyProton versus Photon | Radiation | Photon, Radiotherapy, Proton, Radiotherapy |
Primary outcome
The combined burden of patient-reported dysphagia, xerostomia, pain and speech measured as the area under the curve (AUC) with EORTC QLQ-H&N43 at baseline, end of treatment, 3-, 6- and 12-months following radiotherapy.
Time frame: 12 Months
5 secondary outcomes
Time from date of randomisation to date of loco-regional failure, distant metastasis or death from all causes, whichever comes first.
Time frame: 10 Years
Occurrence of at least one event grade 2 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 3 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 4 toxicity as defined by CTCAE v5.0.
Time frame: 12 Months
Time from date of randomisation to date of death (all causes).
Time frame: 10 Years
The combined toxicity burden of dysphagia, xerostomia, pain and speech measured with QLQ-H&N43 5 years after treatment.
Time frame: 5 Years
Time from date of randomisation to the first documented loco-regional failure.
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanne Eide, MD PhD principal investigator
Oslo University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proton Radiotherapy in people with HNSCC, run by Oslo University Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbro Berggren, Cand.Scient (004722934000, barbbe@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The combined burden of patient-reported dysphagia, xerostomia, pain and speech measured as the area under the curve (AUC) with EORTC QLQ-H&N43 at baseline, end of treatment, 3-, 6- and 12-months following radiotherapy. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.