Actively Recruiting
Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
Led by Oslo University Hospital · Updated on 2026-05-12
400
Participants Needed
4
Research Sites
1513 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
K
Klinbeforsk
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 40 years or older
- Histologically or cytologically confirmed squamous cell carcinoma in oral cavity, oropharynx, hypopharynx, or larynx
- Planned for curative standard radiotherapy, either definitive or postoperative, with or without cisplatin chemotherapy
- ECOG performance status of 0 to 2
- Ability to complete patient questionnaires and comply with study procedures
- Able to answer questionnaires in Norwegian or English
- Willingness to travel to Oslo or Bergen for proton therapy if randomized to that treatment arm
You will not qualify if you...
- Glottic cancers classified as cT1-T2 cN0 cM0
- Nasopharyngeal carcinomas, sino-nasal cancers, and salivary gland carcinomas of the head and neck
- Presence of distant metastases
- Previous radiotherapy to the head and neck area
- Presence of pacemakers or implanted defibrillators
- Prior malignancy within the last 5 years, except for radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer
- Inability to participate due to equipment restrictions (treatment board weight limit of 150 kg)
- Any serious or unstable medical, psychiatric, or other condition that may interfere with safety or study participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Haukeland University Hospital
Bergen, Norway, 5051
Not Yet Recruiting
2
Oslo University Hospital, Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
3
University Hospital of Northern Norway
Tromsø, Norway, 9038
Not Yet Recruiting
4
St. Olavs Hospital
Trondheim, Norway, 7006
Not Yet Recruiting
Research Team
B
Barbro Berggren, Cand.Scient
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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