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NCT06248996: ARTSCAN VI

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

Recruiting now Phase 3 Last updated 19 September 2024
What this trial tests

Phase 3 trial testing Hyperfractionated radiotherpy in Head and Neck Squamous Cell Carcinoma in 308 participants. Currently enrolling.

Timeline
4 March 2024
Primary endpoint
4 March 2028
4 March 2033

Quick facts

Lead sponsorLund University Hospital
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment308
Start date4 March 2024
Primary completion4 March 2028
Estimated completion4 March 2033
Sites11 locations across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Lund University Hospital

Who can join

Adults 18 to 100, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

Other Lund University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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