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NCT Number: NCT07580300

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

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.

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Key information

Conditions

HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Proton Radiotherapy

Radiation

Proton versus Photon

Primary outcomes

  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.

    Time frame: 12 Months

Secondary outcomes

  1. Time from date of randomisation to date of loco-regional failure, distant metastasis or death from all causes, whichever comes first.

    Time frame: 10 Years

  2. Occurrence of at least one event grade 2 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 3 toxicity as defined by CTCAE v5.0 at 12 months.Occurrence of at least one event grade 4 toxicity as defined by CTCAE v5.0.

    Time frame: 12 Months

  3. Time from date of randomisation to date of death (all causes).

    Time frame: 10 Years

  4. The combined toxicity burden of dysphagia, xerostomia, pain and speech measured with QLQ-H&N43 5 years after treatment.

    Time frame: 5 Years

    Toxicity burden measured with QLQ-H&N43

  5. Time from date of randomisation to the first documented loco-regional failure.

    Time frame: 3 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Barbro Berggren, Cand.Scient

CONTACT

[email protected]

004722934000

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Klinbeforsk
  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.

Acronym: PRORADNOR-RCT

Important dates

Study start
2026
Primary completion
2030
Study completion
2055
First posted
May 12, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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