An observational study in Head & Neck Cancer, sponsored by Oslo University Hospital. Recruiting at 4 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Oslo University Hospital · Observational
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
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Recurrent or second primary head and neck cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation: Proton radiotherapy
Re-irradiation with relapsed/secondary primary HNC disease
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
Time frame: From enrollment untill 6 Months post-treatment
Loco-regional control
Proportion of patients with loco-regional control 6 months, 12 months and 3 years post-treatment.
Time frame: 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.
Time frame: 5 years
Overall survival
Median survival from diagnosis of relapse or second primary; proportion alive at 6 and 12 months, 3 and 5 years.
Time frame: 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
Time frame: 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.
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2030, 43 months later.
Of 215 non-industry observational studies under Head and Neck Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 144. This study's planned 43 months is below that.
Counting every sponsor, half of 237 studies reached it within 71 months; a quarter within 29 and three quarters within 142.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.