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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Melody Chin
+44 (0)1865 223464
futuregb@nds.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - FUTURE-GB: Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours

FUTURE-GB: Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours

Medical Conditions

Glioblastoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
Glioblastoma (GB) is the most common primary brain tumour and is incurable. It grows very quickly from the brain tissue itself, rather than from a cancer elsewhere in the body. It is expected that the number of people with a brain tumour will rise by 6% in the UK between 2014 and 20351. However, prognosis (outcome) remains extremely poor, with most people surviving just over 12 months, and as a patients tumour grows patients experience a reduction (decline) in their quality of life. Therefore, we need to ensure quality of life, which remains difficult. The main treatments for GB are surgery, radiotherapy and chemotherapy, given in combination.
For patients where it is thought that surgery will benefit, a surgeon often removes as much tumour as possible, whilst limiting the risk of causing damage, such as weakness, speech, or cognitive difficulties. However, which technology a surgeon should use during surgery to remove the tumour safely is unclear. This can affect how soon the cancer returns, what effects of surgery or symptoms a patient develops, and how a patient feels.
High-frequency sound waves that create an image, called Ultrasound (US), is one of the tools a surgeon can use during the operation to find the tumour and see how much is removed. Another technology, Diffusion Tensor Imaging (DTI), allows important nerve pathways involved in certain functions, for example, speech/language, vision and movement, to be avoided in surgery.
This trial aims to see if GB surgery with these extra technologies (tools) added to the standard ones, increases a patient’s good functioning quality of life, so-called Deterioration Free Survival (DFS).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Dec 2020 30 Apr 2025

Publications

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36379652/ (added 23/11/2022)

Participants will be randomly allocated to receive either brain surgery with standard methods without US and DTI, or surgery with the addition of US and DTI as well as standard tools. Patients may not know into which group they have been placed. They will be recruited from at least 15 NHS hospitals that routinely undertake GB surgery and have access to these tools. The trial will result in only minor changes to the present care pathway. After agreeing to take part, participants will be asked to complete questionnaires about their quality of life, such as their walking, ability to look after their personal hygiene, how they feel. They will also have a brief physical and cognitive/functional assessment before their surgery. Afterwards, the questionnaires and assessments will be repeated, before leaving hospital, and at three monthly intervals until 24 months after agreeing to take part (consenting). These will be combined with planned hospital visits. How long a patient lives will also be recorded.


Adults aged 18 - 70 years, with a primary GB tumour which is maximally resectable and are suitable candidates for the treatment under investigation.

You can take part if:


Current participant inclusion criteria as of 05/04/2022:
1. Aged 18 - 70 years
2. Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour)
3. Patient is suitable for concomitant 6 weeks adjuvant radiotherapy and temozolomide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision
4. Able to receive 5-ALA
5. Willing and able to give informed consent
6. Able to complete trial questionnaires, this may be with support where English is not their first language (where compatible with the validation of questionnaires). (Stage 2 only)
7. Able to provide a proxy who is willing to complete questionnaires as reque


You may not be able to take part if:


1. Midline/basal ganglia/cerebellum/brainstem GB 2. Multifocal GB 3. Recurrent GB4. Suspected secondary GB5. Contraindication to MRI


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Stoke University Hospital
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • Southmead Hospital
    Southmead Rd
    Bristol
    BS10 5NB
  • University Hospital of Wales
    Heath Park Way
    Cardiff
    CF14 4XW
  • Queen's Medical Centre
    Derby Road
    Nottingham
    NG7 2UH
  • The Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle upon Tyne
    TS1 4LP
  • Queen's Hospital
    Rom Valley Way
    Romford
    RM7 0AG
  • John Radcliffe Hospital
    Oxford University Hospitals NHS Trust Headley Way Headington
    Oxford
    OX3 9DU
  • Leeds General Infirmary
    Great George St
    Leeds
    LS1 3EX
  • St Mary's Hospital
    The Bays South Wharf Road
    London
    W2 1BL
  • The Walton Centre
    Lower Lane
    Liverpool
    L9 7LJ
  • Hull Royal Infirmary
    Anlaby Rd
    Hull
    HU3 2JZ
  • James Cook University Hospital
    Marton Rd
    Middlesbrough
    TS4 3BW
  • Kings College Hospital
    Denmark Hill Brixton
    London
    SE5 9RS
  • Addenbrookes Hospital
    Hills Rd
    Cambridge
    CB2 0QQ
  • Ninewells Hospital
    James Arrott Drive
    Dundee
    DD2 1SG
  • The Royal Infirmary of Edinburgh
    51 Little France Crescent Old Dalkeith Rd
    Edinburgh
    EH16
  • Royal London Hospital
    Department of Neurosurgery, Royal London Hospital Whitechapel
    London
    E1 1BB
  • Derriford Hospital
    South West Neurosurgery Centre
    Plymouth
    PL6 8DH
  • Southampton General Hospital
    Tremona Rd
    Southampton
    SO16 6YD
  • Royal Hallamshire Hospital
    Glossop Rd Broomhall
    Sheffield
    S10 2JF

There may not be any direct benefit to the patient, however, information gathered will benefit future patients. There are no additional risks.

Ms Melody Chin
+44 (0)1865 223464
futuregb@nds.ox.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford and funded by National Institute for Health Research EME Programme.




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Read full details for Trial ID: ISRCTN38834571

Or CPMS 45956

Last updated 06 August 2024

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