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Study identifier: NCT06248996 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

Condition: Head and Neck Squamous Cell Carcinoma  ·  Sponsor: Lund University Hospital

PhasePhase 3
Planned participants308
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy. In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.

This description comes directly from the study's public registry record.

Talk to the study team

Maria Gebre-Medhin, MD  ·  +46 46 17 75 20  ·  maria.gebre-medhin@skane.se

Ingrid Müchler  ·  +46 725 96 05 10  ·  Ingrid.Muchler@skane.se

Always discuss trial participation with your own doctor first.

Locations (11)

Gävle HospitalGävle, SwedenNot Yet Recruiting
Sahlgrenska University HospitalGothenburg, SwedenNot Yet Recruiting
Jönköping HospitalJönköping, SwedenNot Yet Recruiting
Karlstad HospitalKarlstad, SwedenNot Yet Recruiting
Linköping University hospitalLinköping, SwedenNot Yet Recruiting
Lund University HospitalLund, SwedenRecruiting
Örebro University HospitalÖrebro, SwedenNot Yet Recruiting
Karolinska University HospitalStockholm, SwedenNot Yet Recruiting
University HospitalUmeå, SwedenRecruiting
Uppsala Accademical HospitalUppsala, SwedenNot Yet Recruiting
Västmanlands Hospital VästeråsVästerås, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT06248996