Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.

Sponsor
Oslo University Hospital
Study ID
NCT07580300
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Proton Radiotherapy — RADIATION
    Proton versus Photon

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
Apr 28, 2030
Completion
Apr 28, 2055

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Proton, Radiotherapy
  • Active Comparator: Photon, Radiotherapy

Primary Outcome Measure

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. [ Time Frame: 12 Months ]

Central Contacts

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