Surgery for Recurrent Glioblastoma
This study is for people in the UK who have glioblastoma, a type of aggressive brain cancer, that has come back after initial treatment. Even with advances in medicine and surgery, glioblastoma often returns. While a second surgery to remove the tumour again has been done safely, it's not clear if it truly helps people live longer. Previous studies have given mixed results, so this trial aims to find a clearer answer. The main goal is to compare two approaches: having a second surgery followed by further treatment, versus just having further treatment without another surgery. The study will look at how long people live, their ability to function, and their overall quality of life. The findings will help doctors understand the best way to treat glioblastoma when it returns and could guide future, larger studies.
At a glance
What is this study about?
Glioblastoma is a serious and fast-growing type of brain cancer. Even after initial treatments like surgery, radiotherapy, and chemotherapy, it nearly always comes back, often within a few months. When the cancer returns, doctors face a challenge in deciding the best next steps. One option is to have another surgery to remove as much of the tumour as possible, followed by more treatments. The idea behind this is to reduce the amount of cancer in the brain, hoping that it makes other treatments more effective and helps people live longer.
However, it's not entirely clear if having a second surgery always leads to a better outcome. While some past studies suggest it might help, others haven't found a clear benefit. Performing brain surgery carries risks, and doctors need to weigh these risks against potential benefits. This study aims to provide a clearer answer by directly comparing people who have a second surgery with those who don't, but still receive other treatments.
This trial is a 'Phase 2' study, which means it's one of the earlier steps in testing a new treatment approach. The main goal is to see if a second surgery, alongside further treatments, helps people with recurrent glioblastoma live longer, maintain their brain function, and have a better quality of life compared to those who only receive further treatments. The information gathered will also be used to plan a larger 'Phase 3' study, which would provide even stronger evidence about the best course of action.
Key takeaways
- This study is for adults with glioblastoma that has returned after initial treatment.
- It compares a second surgery plus treatment, to treatment alone.
- The main goal is to see if surgery improves survival, function, and quality of life.
- Participation involves strict eligibility checks, including detailed brain scans.
- It's a 'Phase 2' study, helping gather information for future, larger trials.
- You might be randomly assigned to either the surgery or non-surgery group.
Who may be eligible?
This study is looking for adults aged 18 or over. To be considered, you must have been previously diagnosed with glioblastoma that has been confirmed by a lab test, and you must have already had standard treatments like surgery and radiotherapy.
Your glioblastoma must have started to grow back (this is called 'recurrence' or 'progression'), but not within the first 3 months after finishing your radiotherapy. Importantly, scans of your brain must show that it's possible to safely remove the new tumour growth without causing significant problems with your speech or movement. A team of experts will review your scans to confirm this.
You cannot have features on your brain scan that suggest the tumour is too widespread, such as extending to the other side of the brain, or problems that make surgery too risky, like the tumour being too close to major blood vessels or important brain areas for speech and movement. You also need to be generally well and able to carry out most daily activities, as measured by a score called KPS of 70 or higher.
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 been diagnosed with glioblastoma confirmed by a biopsy?
- Has your glioblastoma returned after initial surgery and radiotherapy?
- Do scans show that the new tumour can likely be removed safely?
- Are you able to perform most of your daily activities (KPS score of 70 or higher)?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will have a second surgery to remove the tumour, followed by further treatments (like medication). The other group will go straight to receiving further treatments, without another surgery.
You'll have regular check-ups and brain scans (MRIs) throughout the study to monitor your health and the tumour's growth. Doctors will also check your neurological function (like speech and movement) and ask you questions about your quality of life to understand how you are feeling. The exact number of visits and tests will be explained in detail by the study team, along with the total length of time you'll be part of the study. All treatments, assessments, and follow-ups will be closely managed by the clinical team.
Potential risks and benefits
Locations (25)
- Universitätsklinikum InnsbruckVerified postcodeInnsbruck, Austria· Recruiting
- Johannes Kepler University Linz University, Clinic for NeurosurgeryVerified postcodeLinz, Austria· Recruiting
- Medical University of Vienna, Department of NeurosurgeryVerified postcodeVienna, Austria· Recruiting
- Centre Hospitalier Universitaire Dijon Bourgogne, Department of NeurosurgeryVerified postcodeDijon, France· Recruiting
- Hospices Civils de Lyon - CHU de Lyon, Department of Neuro-OncologyVerified postcodeLyon, France· Recruiting
- Assistance Publique - Hôpitaux de Marseille, Department of Neuro-OncologyVerified postcodeMarseille, France· Recruiting
- Centre Hospitalier Universitaire de Nice, Department of NeurosurgeryVerified postcodeNice, France· Recruiting
- Assistance Publique - Hôpitaux de Paris (AP-HP), Department of NeurosurgeryVerified postcodeParis, France· Recruiting
- Centre Hospitalier Universitaire de Saint-Étienne, Department of NeurosurgeryVerified postcodeSaint-Etienne, France· Recruiting
- Institut de Cancérologie Strasbourg Europe (ICANS), Department of OncologyVerified postcodeStrasbourg, France· Recruiting
- Centre Hospitalier Régional et Universitaire de Tours (CHRU Tours), Department of NeurosurgeryVerified postcodeTours, France· Recruiting
- Helios Klinikum ErfurtVerified postcodeErfurt, Germany· Recruiting
Common questions
What is glioblastoma?
Glioblastoma is a fast-growing and serious type of brain cancer that often comes back even after treatment.
What does 'recurrent' mean?
Recurrent means the cancer has returned or started to grow again after it was initially treated.
Why is this study needed?
This study is needed because doctors aren't sure if a second surgery for recurrent glioblastoma truly helps people live longer or better. It aims to find a clear answer.
Will I definitely have surgery if I join?
No, you will be randomly assigned to either have surgery followed by other treatments, or just other treatments. It's like flipping a coin.
What is a 'Phase 2' trial?
A Phase 2 trial is an early stage study that looks at whether a new treatment or approach is effective and safe, and helps plan for larger studies.
How to find out more
Philippe Schucht, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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