NCT07922967Recruiting
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 20 Nov 2026
- Primary completion date
- 20 Jun 2030
- Lead sponsor
- Oslo University Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07922967
What you commit to
- Study type: Observational
- Planned participants: 60
- From 20 Nov 2026 to the primary completion date, 20 Jun 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 design.
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 re-irradiation for overlapping second primary or relapse
- Comparative treatment planning showing an overall benefit of photon therapy compared to proton therapy
Other illness
- Severe late effects after primary radiotherapy (osteoradionecrosis, trismus grade 3 or dysphagia grade 3 before recurrence or second primary disease)
Other
- Distant metastasis
- Patients with pacemaker/ and/or implanted defibrillators.
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile 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 Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| University Hospital of North 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.