NCT07922967 Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
| NCT ID | NCT07922967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Head & Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-11-20 |
| Primary Completion | 2030-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-11-20 with a primary completion date of 2030-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07922967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head & Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07922967 currently recruiting?
Yes, NCT07922967 is actively recruiting participants. Contact the research team at cecia@ous-hf.no for enrollment information.
Where is the NCT07922967 trial being conducted?
This trial is being conducted at Bergen, Norway, Oslo, Norway, Tromsø, Norway, Trondheim, Norway.
Who is sponsoring the NCT07922967 clinical trial?
NCT07922967 is sponsored by Oslo University Hospital. The trial plans to enroll 60 participants.
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