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

NCT07580300 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • HNSCC

Interventions

RADIATION

Proton Radiotherapy

Proton versus Photon

Sponsors & Collaborators

  • Klinbeforsk

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Hanne Eide, MD PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2030-04-28
Completion
2055-04-28

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580300 on ClinicalTrials.gov