Biologically adaptive radiotherapy for oropharyngeal Cancer (BARitOne): An R-IDEAL stage 2a-2b technical optimisation, feasibility, and safety study - Study protocol.

Authors

S Anderson, M C Douglas, R Valentine, L Grocutt, G J Inman, L Hay, S Wright, K Mair, C Kelly, R Seddon, A Shaw, MacMillan A, J Gourlay, J Flach, E Au, C Vens, C Schoenherr, D Grose, C Lamb, S Schipani, S Vohra, C Wilson, C Paterson

Published in

Clinical and translational radiation oncology. Volume 60. Pages 101245. Epub Jul 25, 2026.

Abstract

The incidence of head and neck squamous cell cancer (HNSCC), including HPV-positive and negative oropharyngeal squamous cell cancer (OPSCC) is rising. HPV-negative and some HPV-positive OPSCC has poor outcomes. Attempts to uniformly intensify treatment in poor-prognosis HNSCC populations have been unsuccessful. Diffusion-weighted MRI (DW-MRI) has been used during radiotherapy to identify OPSCC which will fail standard radiotherapy. Biologically-adaptive, DW-MRI guided radiotherapy may allow dose-escalated radiotherapy to be delivered to populations predicted to fail standard treatment, i.e. those really in need of treatment intensification. While individual components of response-adapted workflow are not novel, their combination is significantly different. The BARitOne (Biologically Adaptive Radiotherapy for Oropharyngeal Cancer) study aims to allow optimisation and evaluate feasibility of this approach.
BARitOne is a single-centre R-IDEAL stage 2a and b study of patients with poor-prognosis stage 3-4b OPSCC undergoing single-modality radical radiotherapy. All participants commence standard radiotherapy, 65Gy in 30 fractions. DW-MRI at fraction 1 and 10 assess change in apparent diffusion coefficient (ADC) in primary and nodal disease and stratify tumours into 'responders' and 'non-responders'. Non-responders receive dose-escalation (40.5Gy in 15 fractions) to the gross tumour volume (GTV) for fractions 16 to 30;total dose 73Gy in 30 fractions to GTV. Responders continue standard treatment. The primary aim is to evaluate the proportion of participants that complete DW-MRI guided response-adapted radiotherapy.
Identifying non-responding tumours is an essential step towards individualising intensified radiotherapy for high-risk disease. The additional burden that image-guided, response-adaptive radiotherapy brings, along with the imperative to avoid gaps in radical treatment means workflow needs development and optimised prior to large-scale implementation and comparison to the current standard. BARitOne offers this, with learning also transferrable to other tumour types. While uniform treatment intensification for entire poor-prognostic HNSCC populations has failed to improve survival outcomes, this individualised and biomarker-guided approach to intensification offers an alternative strategy.
International Standard Randomised Controlled Trial Number ISRCTN45653542.

PMID:
42568775
Bibliographic data and abstract were imported from PubMed on 08 Aug 2026.

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