RecruitingOBSERVATIONAL

The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)

The PALSUR study is looking into the best treatment for people with a serious type of brain tumour called high-grade glioma. Doctors aren't always sure whether to suggest palliative care (focusing on comfort and support), taking a small sample of the tumour (biopsy), or removing more of the tumour (resection), especially when people aren't feeling very well to begin with. This study will follow patients who receive one of these three approaches to see how it affects their survival and quality of life over time. It aims to help doctors understand if certain patients benefit more from one treatment over another and how to identify them before any treatment begins. It's an observational study, meaning researchers will watch what happens to patients who are already receiving one of these usual care options.

At a glance

Status

Recruiting

Sponsor

Jasper Gerritsen

Enrolment target

1,015

Start

01 Jan 2023

Estimated completion

01 Jan 2029

Glioblastoma Glioblastoma Multiforme Glioblastoma, IDH-wildtype Glioblastoma Multiforme, Adult

What is this study about?

When someone is diagnosed with a serious type of brain tumour called high-grade glioma, doctors face a challenge in deciding the best course of action. There isn't a clear agreement on whether it's better to focus on comfort and symptom relief (palliative care), take a small piece of the tumour for testing (a biopsy), or try to remove a larger part of the tumour through surgery (resection). This decision can be even more complicated if the person is already feeling quite unwell.

The PALSUR study is an important international research project that wants to understand this better. It will involve many hospitals across Europe and the United States. Researchers will observe patients who are already receiving one of these three types of care – palliative care, a biopsy, or a tumour removal operation – and track their progress. They want to see how each approach affects how long people live and their overall quality of life.

The main goal is to learn if certain patients benefit most from a specific treatment and if there are ways to identify these patients early on, even before an operation. The study will look at things like how patients feel, their symptoms, and their general well-being at different times after they start their treatment. This information will help doctors make more informed decisions and offer the best possible care to future patients with high-grade glioma.

Key takeaways

The study compares three approaches for a serious brain tumour: comfort care, a small operation, or a larger operation.
It aims to find out which treatment gives the best survival and quality of life for certain patients.
Participation involves filling out questionnaires at set times over one year.
Your treatment choice will be made with your medical team, not by the study.
The findings could help doctors make better decisions for future patients.

Who may be eligible?

To be considered for this study, you would need to be an adult between 18 and 90 years old. You must have been diagnosed with a high-grade glioma brain tumour, which doctors identify using special scans like an MRI. It's also essential that you are able to understand the study information and provide your written agreement to take part.

There are certain reasons why someone might not be able to join. For example, if your tumour is located in specific tricky areas of the brain like the cerebellum, brainstem, or midline. Also, if you have had an earlier, less serious brain tumour that turned into a high-grade glioma, or if you've been diagnosed with another serious cancer in the last five years (unless it was a very early skin cancer or an in-situ carcinoma that was successfully treated) 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 aged between 18 and 90 years?
Have you been diagnosed with a high-grade brain tumour (glioma) on an MRI scan?
Are you able to agree to take part in writing?
Is your tumour NOT located in the cerebellum, brainstem, or midline?
Have you NOT had another serious cancer diagnosis in the last 5 years (except for certain mild skin cancers or successfully treated early cancers)?

Answer every question to see your result.

What does participation involve?

If you join the PALSUR study, you will be observed as you receive one of the usual care options for high-grade glioma: palliative care, a tumour biopsy, or a tumour removal operation. The researchers will not decide which treatment you receive; that decision will be made by you and your medical team, just like it would outside of the study.

You will have assessments when you first start (this is called 'baseline') and then again at about 6 weeks, 3 months, and 6 months after your initial treatment. These assessments will involve completing questionnaires about your quality of life and general well-being. Your doctors will also record information about your physical health. The total time you would be followed in the study is up to one year, but the entire study is expected to last five years.

Potential risks and benefits

This is an observational study, meaning you will receive standard medical care based on decisions made by you and your doctors, not by the study itself. Therefore, the direct risks and benefits are those associated with your chosen medical treatment (palliative care, biopsy, or resection), rather than the study. The potential benefit of participating is contributing valuable information that could help improve care for future patients with similar conditions. You have the right to withdraw from the study at any time without affecting your medical 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 Centre
Verified postcode
The Hague, Netherlands· Recruiting
Inselspital Universitätsspital Bern
Verified postcode
Bern, Switzerland· Not yet recruiting

Common questions

What is 'high-grade glioma'?

It's a serious type of brain tumour that grows quite quickly.

What does 'palliative care' mean in this study?

It refers to care focused on comfort and managing symptoms, rather than trying to cure the tumour.

Will the study tell me what treatment to have?

No, the study won't tell you what treatment to have. Your doctor and you will decide that together, as usual.

How long will I be involved in the study?

You'll be followed for up to one year, with check-ups at 6 weeks, 3 months, and 6 months.

What will I have to do if I join?

You'll fill out some questionnaires about your quality of life at different times after your treatment.

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.