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Recruiting NCT07580300

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

Phase III Interventional HNSCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proton Radiotherapy.
Who it may be relevant to
Registry conditions: HNSCC. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Proton Radiotherapy
    Proton versus Photon

Primary outcome measures

  • 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 outcome measures (5)
  • 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]
  • 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]
  • Time from date of randomisation to date of death (all causes). [Time frame: 10 Years]
  • The combined toxicity burden of dysphagia, xerostomia, pain and speech measured with QLQ-H&N43 5 years after treatment. [Time frame: 5 Years]
  • Time from date of randomisation to the first documented loco-regional failure. [Time frame: 3 Years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 4 centers
  • Haukeland University Hospital — Bergen
  • Oslo University Hospital, Radiumhospitalet — Oslo
  • University Hospital of Northern Norway — Tromsø
  • St. Olavs Hospital — Trondheim

Identifiers

NCT: NCT07580300 · 912158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗