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

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 include

Trial Details

NCT ID
NCT06248996
Phase
PHASE3
Sponsor
Lund University Hospital
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Hyperfractionated radiotherpy
  • Control group
Locations (sample)
  • Gävle, Sweden|60.67452,17.14174
  • Gothenburg, Sweden|57.70716,11.96679
  • Jönköping, Sweden|57.78145,14.15618
  • Karlstad, Sweden|59.3793,13.50357
  • Linköping, Sweden|58.41086,15.62157

Key Eligibility Criteria

  • The patient must be at least 18 years old.
  • Histologically or cytologically confirmed, previously untreated, HNSCC of the oropharynx, hypopharynx, larynx or oral cavity without distant metast…
  • The primary tumour must fulfil the following high-risk criteria:
  • For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal diameters must render a tumour estimate of ≥30 cc.

For full eligibility, visit ClinicalTrials.gov.

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