FUTURE-GB: functional and ultrasound-guided resection of glioblastoma – a two-stage randomised control trial
,
Ruichong Ma,
Jonathan Cook,
Giles Critchley,
Damian Holliman,
Chittoor Rajaraman,
Amy Taylor,
Peter McCulloch,
Michael D Jenkinson,
Paul M Brennan,
Vicki S Barber,
Huan Chan,
Jose Lavrador,
Keyoumars Ashkan,
Neil Barua,
Matthew Williams,
Colin Watts,
Dipankar Nandi,
Stuart Smith,
Luke Dixon,
Robert Corns,
Linda Dirven,
Stephen John Price,
Puneet Plaha,
Erminia Albanese,
Anna Solth,
Helen Bulbeck,
Grainne McKenna,
Martin J B Taphoorn,
James Palmer,
Anil Varma,
Maria Velicu,
George Eralil,
Kathrin Whitehouse,
Sophie Camp,
Natalie Voets,
Matthew Grech-Sollars,
Adrian Lim,
Vasileios Apostolopoulos,
Shailendra Achawal,
Ganamurthy Sivakumar,
Farouk Olubajo,
Edward McKintosh,
Dimitrios Paraskevopoulos,
Paul Grundy
Affiliations
University of London, London, UK
Ruichong Ma
Department of Neursurgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Jonathan Cook
Oxford Clinical Trials Research Unit & Surgical Intervention Trials Unit, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, Oxfordshire, UK
Giles Critchley
Damian Holliman
Chittoor Rajaraman
Amy Taylor
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
Peter McCulloch
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
Michael D Jenkinson
Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, Merseyside, UK
Paul M Brennan
Vicki S Barber
Oxford Clinical Trials Research Unit & Surgical Intervention Trials Unit, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, Oxfordshire, UK
Huan Chan
Jose Lavrador
Keyoumars Ashkan
Department of Neurosurgery, King`s College Hospital, London, UK
Neil Barua
Matthew Williams
Department of Clinical Oncology, Imperial College Healthcare NHS Trust, London, UK
Colin Watts
Institute of Cancer and Genomic Studies, University of Birmingham, Birmingham, UK
Dipankar Nandi
Neurosurgery, Imperial College Healthcare NHS Trust, London, UK
Stuart Smith
Luke Dixon
Neuroradiology, Imperial College Healthcare NHS Trust, London, UK
Robert Corns
Linda Dirven
Department of Neurology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
Stephen John Price
Neurosurgery Division, Department of Clinical Neurosciences, Cambridge University, Cambridge, UK
Puneet Plaha
Department of Neursurgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Erminia Albanese
Anna Solth
Helen Bulbeck
Brainstrust, Cowes, UK
Grainne McKenna
Martin J B Taphoorn
Department of Neurology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands
James Palmer
Anil Varma
Maria Velicu
George Eralil
Kathrin Whitehouse
Sophie Camp
Neurosurgery, Imperial College Healthcare NHS Trust, London, UK
Natalie Voets
Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxfordshire, UK
Matthew Grech-Sollars
Department of Computer Sciences, UCL, London, UK
Adrian Lim
Department of Surgery and Cancer, Imperial College London, London, UK
Vasileios Apostolopoulos
Department of Neursurgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Introduction Surgery remains the mainstay for treatment of primary glioblastoma, followed by radiotherapy and chemotherapy. Current standard of care during surgery involves the intraoperative use of image-guidance and 5-aminolevulinic acid (5-ALA). There are multiple other surgical adjuncts available to the neuro-oncology surgeon. However, access to, and usage of these varies widely in UK practice, with limited evidence of their use. The aim of this trial is to investigate whether the addition of diffusion tensor imaging (DTI) and intraoperative ultrasound (iUS) to the standard of care surgery (intraoperative neuronavigation and 5-ALA) impacts on deterioration free survival (DFS).Methods and analysis This is a two-stage, randomised control trial (RCT) consisting of an initial non-randomised cohort study based on the principles of the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) stage-IIb format, followed by a statistically powered randomised trial comparing the addition of DTI and iUS to the standard of care surgery. A total of 357 patients will be recruited for the RCT. The primary outcome is DFS, defined as the time to either 10-point deterioration in health-related quality of life scores from baseline, without subsequent reversal, progressive disease or death.Ethics and dissemination The trial was registered in the Integrated Research Application System (Ref: 264482) and approved by a UK research and ethics committee (Ref: 20/LO/0840). Results will be published in a peer-reviewed journal. Further dissemination to participants, patient groups and the wider medical community will use a range of approaches to maximise impact.Trial registration number ISRCTN38834571.
