Head & Neck CancerPRORADNOR-ReIRNCT07922967
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
An observational study of Head & Neck Cancer, run by Oslo University Hospital at 4 sites in Norway.
Trial summary
Re-irradiation of head and neck cancer due to relaps or new cancer in the same area may be beneficial, but also poses a risk since the area has been given radiation previously. Proton radiation is a new type of radiotherapy which might result in less damage of healthy tissue around the tumour, but it is still… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- Proton radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 4 sitesNorway
- Study dates
- 20 Nov 2026to 20 Jun 2045
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recurrent or second primary head and neck cancer
Who may be able to join
- Informed consent received
- Age ≥ 18 years
- Histological verified squamous cell carcinoma
- Candidate for treatment with curative intent
- Loco-regional recurrence or new second primary ≥ six months after primary radiotherapy
- Medical or surgical inoperable or without free margins ((R1: < 1mm margin /R2: macroscopic residual tumour) or rpN2-3 or extranodal extension (ENE)) after surgical resection
Show all 9Show fewer
- WHO PS ≤ 2
- Ability to understand and complete the study documents
- Complete Response (CR) after previous therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose.
Who cannot join
- Distant metastasis
- Previous re-irradiation for overlapping second primary or relapse
- Severe late effects after primary radiotherapy (osteoradionecrosis, trismus grade 3 or dysphagia grade 3 before recurrence or second primary disease)
- Patients with pacemaker/ and/or implanted defibrillators.
- Comparative treatment planning showing an overall benefit of photon therapy compared to proton therapy
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, 5021
Jon Espen Dale, Principal Investigator, 004755975000, jon.espen.dale@helse-bergen.no
- Recruiting
Oslo University Hospital
Oslo, 4950
Cecilie Delphin Amdal, Principal Investigator, 004722934000, cecia@ous-hf.no
- Not yet recruiting
University Hospital of North Norway
Tromsø, 9038
Thomas Kilvær, Principal Investigator, 004777626000, thomas.kilvaer@unn.no
- Not yet recruiting
St.Olavs Hospital
Trondheim, 7006
Mirjam Delange Alsaker, Principal Investigator, 00474772573000, mirjam.delange.alsaker@stolav.no
About this study
Official title: Patient-reported Tolerability and Loco-regional Control After Proton Therapy in Patients With Recurrent or Second Primary Head and Neck Cancer Eligible for Re-irradiation, a Multicentre Phase II Single Arm Trial
Re-irradiation of head and neck cancer due to relaps or new cancer in the same area may be beneficial, but also poses a risk since the area has been given radiation previously. Proton radiation is a new type of radiotherapy which might result in less damage of healthy tissue around the tumour, but it is still uncertain whether this leads to fewer side effects and improved quality of life. The aim of this study is to collect more knowledge of side-effects, swallowing function, quality of life and disease control after re-irradiation with protons in patients with relaps or second primary head and neck cancer
Read the detailed description
The overall aim of the current study is to evaluate the clinical outcome (survival, tolerability, health-related quality of life) of head and neck cancer re-irradiation with mainly hyperfractionated proton therapy. The results will be compared with aggregated data from historical controls; patients treated with hyperfractionated photon therapy. The results will be used to improve patient selection and treatment for future patients. An important secondary effect will be a national standardization of treatment guidelines and follow up.
- Conditions
- Head & Neck Cancer
- Being tested
- Proton radiotherapy
- Keywords
- Proton, Photon, Radiotherapy, HNC, Re-irradiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton radiotherapyRadiation
Re-irradiation with relapsed/secondary primary HNC disease
| Study group | Role | What they receive |
|---|---|---|
| Recurrance/second primay disease of HNC | Not described Receives: Radiation: Proton radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability -patient-reported dysphagia measured with EORTC QLQ-HN43 dysphagia scale
Change in patient-reported dysphagia measured with the EORTC QLQ-HN43 dysphagia scale group level mean score
Measured: From enrollment untill 6 Months post-treatment
Secondary outcomes (5)
Loco-regional control
Proportion of patients with loco-regional control 6 months, 12 months and 3 years post-treatment.
Measured: From enrollment untill 3 years post-treatment
Disease free survival
Time from date of diagnosis of relapse or second primary disease to date of loco-regional failure, distant metastasis or death from all causes, whichever comes first.
Measured: 5 years
Overall survival
Median survival from diagnosis of relapse or second primary; proportion alive at 6 and 12 months, 3 and 5 years.
Measured: 5 years
Health-related quality of life measured with EORTC QLQ-C30
Change in mean health-related quality of life from baseline to 3, 6 and 12 months, 3 and 5 years post-treatment. measured with EORTC QLQ-C30
Measured: 5 years
Adverse events
Number of patients with grade ≥ 3 toxicities measured with CTCAE v 5 at baseline to 3, 6 and 12 months and 3- and 5 years post-treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Jun 2030 (estimated)
- Study completion20 Jun 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Responsible party
- Principal investigator, Cecilie Delphin Amdal, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922967
- Sponsor's protocol ID
- 2025-25
- Acronym
- PRORADNOR-ReIR
- Status last verified
- Nov 2026
- First submitted
- 1 Jun 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Tolerability and Loco-regional Control After Proton Therapy in Patients With Recurrent or Second Primary Head and Neck Cancer Eligible for Re-irradiation, a Multicentre Phase II Single Arm Trial
- ClinicalTrials.gov ID
- NCT07922967
- Acronym / sponsor ID
- PRORADNOR-ReIR / 2025-25
- Conditions
- Head & Neck Cancer
- Keywords
- Proton, Photon, Radiotherapy, HNC, Re-irradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Jun 2030 (estimated)
- Study completion
- 20 Jun 2045 (estimated)
- First posted
- 6 Nov 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.
Re-irradiation of head and neck cancer due to relaps or new cancer in the same area may be beneficial, but also poses a risk since the area has been given radiation previously. Proton radiation is a new type of radiotherapy which might result in less damage of healthy tissue around the tumour, but it is still uncertain whether this leads to fewer side effects and improved quality of life. The aim of this study is to collect more knowledge of side-effects, swallowing function, quality of life and disease control after re-irradiation with protons in patients with relaps or second primary head and neck cancer
Detailed description
The overall aim of the current study is to evaluate the clinical outcome (survival, tolerability, health-related quality of life) of head and neck cancer re-irradiation with mainly hyperfractionated proton therapy. The results will be compared with aggregated data from historical controls; patients treated with hyperfractionated photon therapy. The results will be used to improve patient selection and treatment for future patients. An important secondary effect will be a national standardization of treatment guidelines and follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrance/second primay disease of HNC | – | Radiation: Proton radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent or second primary head and neck cancer
Key inclusion criteria (9 listed)
- Informed consent received
- Age ≥ 18 years
- Histological verified squamous cell carcinoma
- Candidate for treatment with curative intent
- Loco-regional recurrence or new second primary ≥ six months after primary radiotherapy
Key exclusion criteria (5 listed)
- Distant metastasis
- Previous re-irradiation for overlapping second primary or relapse
- Severe late effects after primary radiotherapy (osteoradionecrosis, trismus grade 3 or dysphagia grade 3 before recurrence or second primary disease)
- Patients with pacemaker/ and/or implanted defibrillators.
- Comparative treatment planning showing an overall benefit of photon therapy compared to proton therapy
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 radiotherapyRe-irradiation with relapsed/secondary primary HNC disease | Radiation | Recurrance/second primay disease of HNC |
Primary outcome
Tolerability -patient-reported dysphagia measured with EORTC QLQ-HN43 dysphagia scale
Time frame: From enrollment untill 6 Months post-treatment
Change in patient-reported dysphagia measured with the EORTC QLQ-HN43 dysphagia scale group level mean score
5 secondary outcomes
Loco-regional control
Time frame: From enrollment untill 3 years post-treatment
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Health-related quality of life measured with EORTC QLQ-C30
Time frame: 5 years
Adverse events
Time frame: 5 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 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Head & Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head & Neck Cancer, 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 9 inclusion and 5 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 6 Nov 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.
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 Cecilie Delphin Amdal, Principal Investigator (004722934000, cecia@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability -patient-reported dysphagia measured with EORTC QLQ-HN43 dysphagia scale (time frame: From enrollment untill 6 Months post-treatment). 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 6 Nov 2026.