RecruitingPHASE2INTERVENTIONAL

Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma

This study is for adults with glioblastoma, a type of brain cancer. Standard treatments don't always stop the cancer from coming back quickly. This trial explores a new radiation technique called Simultaneous Integrated Boost (SIB) that allows doctors to give a higher dose of radiation directly to the tumour. To make this more effective, they are using a special scan called FDOPA PET. This scan helps find the most aggressive parts of the tumour, so the SIB radiation can be focused there. The main goal is to improve how long patients live without the cancer growing, especially for those who are more fragile or whose tumour couldn't be fully removed by surgery.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Paul Strauss

Enrolment target

Start

23 Jun 2025

Estimated completion

01 Jul 2029

Glioblastoma Multiforme, Adult

What is this study about?

Glioblastoma is the most common and serious type of brain cancer in adults. While there are standard treatments involving surgery, chemotherapy, and radiation, the cancer often returns within a few months, and patients generally live for about 15 to 18 months.

This study aims to improve treatment for certain patients, particularly those who are frail, older, or whose tumour couldn't be completely removed by surgery. For these patients, doctors want to find ways to make radiation treatment more effective. The cancer often comes back in the same area it started, so giving a stronger radiation dose to that specific spot might help. This trial uses a technique called Simultaneous Integrated Boost (SIB), which allows doctors to deliver a higher dose to the most critical parts of the tumour without increasing the number of treatment appointments. This is less taxing for patients who might be fragile.

To make this SIB radiation even more precise, the researchers are using a special type of scan called an FDOPA PET scan. This scan can highlight areas of the tumour that are more active or aggressive and are more likely to cause the cancer to return. By using the FDOPA PET scan to guide the SIB, the doctors hope to target these aggressive areas with a stronger dose of radiation, while still giving a standard dose to the rest of the tumour. Previous studies have shown that this approach might help delay the cancer's return, and this trial is designed to see if it can improve how long patients live overall.

Key takeaways

Targets aggressive brain cancer (Glioblastoma) in adults.
Uses a special scan (FDOPA PET) to guide focused radiation (SIB).
Aims to give a stronger radiation dose to tumour 'hot spots'.
Could benefit frail patients or those with partially removed tumours.
Goal is to improve how long patients live without the cancer growing.

Who may be eligible?

This study is looking for adults with glioblastoma. There are two main groups of patients they are considering. The first group includes patients who are not suitable for the usual strong treatment due to their overall health, are 18 years or older (up to 70 years if they have a certain level of fitness, called a Karnofsky Index of at least 50%), and have had a biopsy (a small sample taken from the tumour).

The second group is for patients over 70 years old who are still quite active (with a good Balducci score and a Karnofsky Index of at least 60%). This group can include those who had some, but not all, of their tumour removed, or have had a biopsy. Importantly, for all participants, a biopsy must confirm that it is glioblastoma.

You cannot join this study if you are healthy enough for the standard strong treatment, or if you have certain medical conditions that prevent you from having an MRI or PET scan. Also, if there are specific parts of the tumour that are very close to sensitive areas like your optic nerves (which help you see), you might not be able to participate. Finally, the FDOPA PET scan must be able to pick up activity in your tumour for you to 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 an adult with glioblastoma?
Has a biopsy confirmed your glioblastoma?
Are you not well enough for the standard, stronger glioblastoma treatment?
Are you able to have MRI and FDOPA PET scans?
Is your tumour not too close to very sensitive areas like your optic nerves?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have a series of radiation treatments using the special SIB technique guided by an FDOPA PET scan. The study will involve regular check-ups, scans, and tests to monitor your health and how the treatment is working. This will likely include follow-up appointments after your treatment finishes to track your progress over time. The exact number of visits and the full duration of your involvement will be thoroughly explained by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new and potentially more effective treatment for your glioblastoma, especially if standard treatments aren't suitable for you. However, there are also potential risks, including side effects from the radiation treatment, which the doctors will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

CHRU de Nancy
Verified postcode
Nancy, France· Recruiting
Centre Paul Strauss
Verified postcode
Strasbourg, France· Recruiting
ICL
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is Glioblastoma?

Glioblastoma is the most common type of aggressive brain cancer in adults.

What is an FDOPA PET scan?

It's a special scan that helps doctors find the most active, aggressive parts of the tumour, so treatment can be better targeted.

What is SIB radiation?

SIB (Simultaneous Integrated Boost) is a way to give a stronger dose of radiation to specific tumour areas without increasing the number of treatment sessions.

Who is this study for?

It's for adults with glioblastoma who are either delicate, older, or whose tumour couldn't be fully removed by surgery.

Will I get standard treatment with this study?

This study is for patients who are not suitable for the standard, full-intensity treatment, so it offers an alternative approach.

How to find out more

Anne ANTHONY

promotion-rc@institut-strauss.fr +33(0)388252413 Official trial record

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