Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. (NCT07580300) | Clinical Trial Compass
RecruitingPhase 3
Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
Norway400 participantsStarted 2026-04-28
Plain-language 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. 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.
Who can participate
Age range
40 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm.
Exclusion criteria
. 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.