RecruitingOBSERVATIONAL

The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

This research, called the RESBIOP study, is looking into the best way to treat a type of serious brain tumour called high-grade glioma. Specifically, it focuses on older patients (aged 70 and over) or those who are not as active as usual. Currently, doctors don't have clear guidance on whether it's better to remove as much of the tumour as possible with surgery (called resection) or just take a small sample for testing (a biopsy). This study aims to compare these two approaches. Researchers want to see which method leads to better survival, a better quality of life, and fewer problems. They also want to understand which method makes it easier for patients to receive further treatments like chemotherapy and radiotherapy. This is an international study, carefully observing patients over several years.

At a glance

Status

Recruiting

Sponsor

Jasper Gerritsen

Enrolment target

564

Start

01 Jan 2023

Estimated completion

01 Jan 2029

Glioblastoma Glioblastoma, IDH-wildtype Glioblastoma Multiforme Glioblastoma Multiforme, Adult Glioblastoma Multiforme of Brain

What is this study about?

When someone is diagnosed with a serious brain tumour, known as a high-grade glioma, doctors need to decide on the best treatment plan. For older patients (usually 70 and above) or those who are not very active, this decision can be particularly tricky because there aren't clear rules to follow. Some doctors might prefer to remove as much of the tumour as possible through surgery, while others might opt for a smaller operation to just take a sample of the tumour, called a biopsy. This study aims to help doctors make more informed decisions by comparing these two approaches.

The main goal of the RESBIOP study is to understand if one of these methods – removing the tumour or taking a biopsy – leads to better results for patients. Researchers will be looking at how long patients live, their overall quality of life, and whether they experience any new problems after the procedure. An important part of this research is also understanding which approach allows more patients to go on to receive other important treatments like chemotherapy and radiotherapy, which are often vital in treating these types of tumours.

This is an international study, meaning doctors and hospitals from different countries, including Europe and the United States, are working together. They will carefully observe patients over a period of five years. By gathering information from many patients, they hope to get a clearer picture of the best way to care for patients with high-grade gliomas in these specific situations.

Key takeaways

This study compares two surgical options for serious brain tumours: removing the tumour or taking a sample.
It focuses on older patients or those with reduced activity levels.
The aim is to find out which surgical method gives better survival and quality of life.
It also looks at which method allows patients to receive crucial follow-up treatments.
Participation involves observation and assessments over one year after surgery.

Who may be eligible?

To be part of this study, you would generally need to be an adult between 18 and 90 years old. You must have a type of serious brain tumour called high-grade glioma, confirmed by an MRI scan as seen by your neurosurgeon. Importantly, you also need to be able to understand the study and give your written permission to take part.

There are also some reasons why you might not be able to join. For example, if your tumour is located in certain sensitive areas of the brain like the cerebellum or brainstem, or if you have medical devices like a pacemaker that prevent you from having an MRI scan. If you've had certain other cancers in the last five years (unless it was a very specific type of treatable early-stage skin cancer or a carcinoma in situ), or if your high-grade glioma developed from a less serious type of brain tumour, you wouldn't be able to participate. Also, if for any reason you aren't able to give your informed written consent, you wouldn't be eligible.

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 between 18 and 90 years old?
Do you have a high-grade glioma confirmed by an MRI scan?
Are you able to understand the study and provide your written consent?
Is your tumour located in an area that isn't the cerebellum, brainstem, or middle of the brain?
Do you not have medical devices like a pacemaker that would prevent an MRI?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would either have surgery to remove your tumour (resection) or a procedure to take a small sample (biopsy), as decided by your medical team within the study. This choice is part of the study's design to understand the effects of each approach. The study does not involve receiving any new or experimental medications; it's about observing the outcomes of standard surgical approaches.

Over the course of one year after your surgery, you would have several follow-up appointments. These visits would typically happen at 6 weeks, 3 months, 6 months, and 12 months after your operation. During these appointments, doctors will check your progress, neurological health (like movement and thinking skills), and your overall quality of life. This will involve physical examinations, answering questionnaires about your daily life, and having MRI scans to see how your tumour is responding. The total study duration is 5 years, with new patients being included for 4 years, and each patient being followed up for 1 year.

Potential risks and benefits

Participating in research studies like this helps us understand more about illnesses and improve treatments for everyone. A possible benefit of taking part could be closer monitoring of your health and care. However, as with any medical procedure, there are potential risks, such as those associated with the surgery itself (either resection or biopsy) and the assessments involved, like MRI scans. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual hospital care.

Locations (8)

University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
University Hospital Leuven
Verified postcode
Leuven, Belgium· Recruiting
Technical University Munich
Verified postcode
Munich, Germany· Not yet recruiting
University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
Erasmus Medical Center
Verified postcode
Rotterdam, Netherlands· Recruiting
Haaglanden Medical Center
Verified postcode
The Hague, Netherlands· Recruiting
Inselspital Universitätsspital Bern
Verified postcode
Bern, Switzerland· Not yet recruiting

Common questions

What is a 'high-grade glioma'?

It's a type of serious brain tumour that grows quite quickly. Doctors are trying to find the best ways to treat it.

What's the difference between 'resection' and 'biopsy'?

Resection means surgery to remove as much of the tumour as possible. A biopsy means taking only a small sample of the tumour for testing.

Why are they studying older patients specifically?

There's less clear guidance for treating serious brain tumours in older patients or those who are not very active, so this study aims to fill that gap.

Will I get a new drug in this study?

No, this study isn't testing new drugs. It's comparing two common surgical ways of dealing with the tumour (resection vs. biopsy).

How long will I be involved in the study?

You'll be followed up for one year after your surgery, with visits at 6 weeks, 3 months, 6 months, and 12 months.

How to find out more

Jasper Gerritsen, MD PhD

j.gerritsen@erasmusmc.nl +31107036130 Official trial record

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