A study looking at additional radiotherapy for glioblastoma before surgery to improve the outcome of treatment (POBIG)

Cancer type:

Brain (and spinal cord) tumours

Status:

Open

Phase:

Phase 1

This study is looking at having a single dose of radiotherapy targeting the glioblastoma before surgery. This is to reduce the growth of the tumour between surgery and radiotherapy after surgery.

It is open to people in the Greater Manchester area who are:

newly diagnosed with glioblastoma and
who are to have surgery followed by further treatment such as radiotherapy

More about this trial

A standard treatment Open a glossary item for treating glioma is to remove it by surgery and then to have further radiotherapy. The radiotherapy doesn’t start straight after surgery. This is to allow you to get better and for the wound to heal.

Glioma is a fast growing tumour. It can grow in the time after surgery and before starting radiotherapy. Researchers think that giving a single radiotherapy treatment before surgery might slow the growth of the glioma. This is already done for other types of brain tumours and is safe.

The main aims of this study are to find:

whether it is safe to give radiotherapy before surgery
the safe dose of radiotherapy to give before surgery
the first sign on a scan that might show whether radiotherapy before surgery helps to control the tumour

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

don’t need to have urgent or immediate surgery due to symptoms
are newly diagnosed with glioblastoma
are planned to have surgery followed by radiotherapy
have satisfactory blood test results
are able to give informed consent to take part in the study
are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

need to have immediate or urgent surgery
are having surgery only to take a sample (biopsy ) of the tumour
have or might have another cancer apart from non melanoma skin cancer . You can join if had cervical cancer or prostate cancer that was completely removed by surgery. If you had prostate cancer your PSA must be no more than 0.1 ng/ml.
are not able to have an MRI scan with a contrast medium . This could be because you are allergic to the contrast medium used or you can’t be in confined spaces.

Trial design

This is a phase 1 study. The team hope to include 18 people in the study.

Everyone has a single treatment of radiotherapy before having surgery. You have surgery within a week of having the radiotherapy.

Before the radiotherapy you have a planning appointment. This is to make sure the radiotherapy goes where the doctor wants it to.

Before or as part of the planning appointment you have a mask (shell) made that fits over your head. This is to help keep your head still while having radiotherapy. So your treatment is accurate as possible. You wear the mask during the planning appointment and during the radiotherapy treatment.

Samples for research
Everyone gives blood samples for the study. Where possible the team take these when you have a thin tube (cannula Open a glossary item ) already in your vein. This is when you have an MRI scan for the study.

The team also want to collect samples of your tears. To do this they place a small piece of paper in the corner of your eye. This soaks up the tears. They do this before you have your MRI scan. Early research suggests that looking at tears could help with diagnosing and monitoring brain tumours. The team want to find out more.

You don’t have to agree to have the tears samples taken.

Looking at oxygen levels in the glioma
The team want to look at the oxygen levels in the glioma after surgery. To do this you take a pimonidazole tablet about 12 hours before your surgery. Your body absorbs it and it goes to the glioma tissue and highlights where there is low oxygen. After surgery the team look at the glioma tissue in a laboratory to see where these areas are.

You have a small dose of pimonidazole and so there shouldn’t be any side effects. Side effects of pimonidazole include:

generally feeling unwell
feeling confused, dazed or unsettled (disorientated)
sweating

This is not part of your treatment and won’t change your treatment plan in anyway.

You don’t have to agree to do this. You can still take part in the study.

The team use all these samples to find out more about how to treat glioma.

Hospital visits

You see the doctor a week before your radiotherapy. This is:

to have your mask made and for your planning appointment
for MRI scans
for a CT scan

You have a COVID-19 test before and after radiotherapy. Your doctor will tell you more about this.

As part of the routine care you have MRI scans:

after the radiotherapy
after surgery and
before you start radiotherapy after surgery

You have another CT scan after surgery before you start your course of radiotherapy

Side effects

The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Side effects of radiotherapy to the brain include:

swelling of the brain
headaches
feeling or being sick
effects on how the brain works. This can cause difficulty with thinking, difficulty doing tasks, confusion and poor memory.
tiredness
hair loss

We have information about the side effects of radiotherapy to the brain.

Your doctor will talk to you about the possible side effects of treatment and answer any questions you have before you agree to take part.