CompletedInterventional

PreOperative Brain Irradiation in Glioblastoma

This study, called 'PreOperative Brain Irradiation in Glioblastoma,' is investigating a new way to treat glioblastoma, a type of brain tumour. Typically, patients have surgery first, followed by radiotherapy. However, glioblastoma can grow rapidly between these treatments. This research aims to find out if giving radiotherapy *before* the operation is safe and effective in slowing down the tumour's growth during that waiting period. Researchers will also look for new ways to diagnose and monitor glioblastoma by examining oxygen levels in the tumour and collecting tear samples. The study hopes to improve current treatments for this serious condition.

At a glance

Status

Completed

Sponsor

The Christie NHS Foundation Trust

Enrolment target

Start

23 May 2022

Estimated completion

30 Nov 2025

Glioblastoma

What is this study about?

Glioblastoma is a serious and fast-growing type of brain tumour. While current treatments include surgery followed by radiotherapy, it's not a cure. There's often a waiting period between surgery and radiotherapy for patients to recover, and during this time, the tumour can unfortunately continue to grow.

This study is exploring a new approach: giving some radiotherapy *before* the operation. The main goals are to find the safest way to do this without causing problems for the surgery and to see if this earlier treatment can help to slow down the tumour's growth before it's removed. Researchers will look at tumour samples taken during surgery and compare scans from before and after this early radiotherapy.

The study also has two optional parts. One involves looking at the oxygen levels within the tumour, as low oxygen can sometimes mean treatments are less effective. The other optional part is collecting tear samples (a film from the corner of the eye) – early research suggests this might help diagnose brain tumours and monitor how well treatments are working. By gathering this information, the study hopes to improve future treatments and possibly find easier ways to diagnose and track glioblastoma.

Key takeaways

Tests giving radiotherapy before brain surgery for glioblastoma.
Aims to slow tumour growth before surgery and find safe treatment methods.
Involves extra scans, blood tests, and close monitoring.
Optional parts explore tumour oxygen levels and tear samples for diagnosis.
May delay surgery by about a week; potential radiotherapy side effects will be monitored.
Hopes to improve glioblastoma outcomes by treating tumours earlier.

Who may be eligible?

This study is looking for adults aged 18 or over who have been newly diagnosed with glioblastoma based on brain scans. Participants should generally be well enough to take care of themselves and do light activities. Their doctors (a specialist team) must also agree that joining the study is safe for them and that delaying surgery slightly for the early radiotherapy won't cause them harm.

There are some conditions that would prevent someone from joining. For example, if you've had certain other cancers in the last three years (apart from some skin cancers or successfully treated cervical or prostate cancer), or if you can only have a biopsy rather than surgery, you might not be suitable. You also need to be able to have MRI scans and give your informed consent to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with glioblastoma based on a scan?
Are you generally well enough for everyday activities?
Have you discussed this study with your specialist team?
Can you have MRI scans?
Have you had certain other cancers in the last 3 years (not including some skin, cervical, or prostate cancers)? (If yes, you might not be eligible).

Answer every question to see your result.

What does participation involve?

If you consider joining, the study will be explained in detail at your first appointment, and you'll receive an information sheet. You'll have time to think about it and ask questions. If you agree, you'll sign a consent form. While in the study, you'll have four blood tests and four MRI scans. You'll also have one CT scan, which helps plan the radiotherapy.

The study involves receiving a planned course of radiotherapy before your surgery. One day after this radiotherapy, the study team will check in with you about any side effects. After your surgery, you'll have another MRI scan before you leave the hospital, and your progress will be monitored regularly by the study team, along with your usual hospital appointments.

There are two optional parts you can choose to take part in: if you agree, you might take a special tablet (pimonidazole hydrochloride) 8-16 hours before your operation to help measure tumour oxygen levels. Also, if you agree, small tear samples will be collected during your MRI scans by placing a tiny paper strip at the corner of your eye. These optional parts aim to gather more information for research.

Potential risks and benefits

A potential benefit of taking part is that parts of the tumour that can't be removed during surgery would receive radiotherapy weeks earlier than usual. This earlier treatment might mean the tumour grows less overall, potentially improving outcomes. However, there are also risks. Your surgery might be delayed by about a week to allow for the early radiotherapy. Common short-term side effects from radiotherapy can include headaches, nausea, tiredness, hair loss, and brain swelling, but you'll be closely monitored and given medication to help manage these. The radiotherapy dose might be slightly higher than standard, and you'll have one extra CT scan which involves a small amount of radiation; while the risk of this causing cancer many years later is very small in people with glioblastoma, it's a possibility. For the optional parts, collecting tear samples might cause short-term irritation, and while no side effects are expected from the pimonidazole tablet at the study dose, higher doses can make people feel unwell.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Christie NHS Foundation Trust
City only
Manchester, United Kingdom
Northern Care Alliance NHS Foundation Trust
City only
Salford, United Kingdom

Common questions

What is glioblastoma?

Glioblastoma is a fast-growing and serious type of brain tumour.

What is the main idea of this study?

The study is testing if giving radiotherapy before brain surgery can help slow down tumour growth over time.

Will my surgery be delayed?

Yes, taking part might delay your surgery by about a week to allow for the early radiotherapy.

What are the optional parts of the study?

The optional parts are looking at oxygen levels in the tumour and collecting tear samples for research into diagnosis.

Who is funding this research?

This study is funded by Cancer Research UK RadNet Manchester and the Medical Research Council.

How to find out more

Melanie Oddy

melanie.oddy@nhs.net +44 (0)161 446 3000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.