AuthorisedTherapeutic exploratory (Phase II)Interventional

Multisite open-label randomized phase II clinical trial in newly diagnosed glioblastoma treated by concurrent TemoRadiation and adjuvant temozolomide +/- ultrasound-induced blood brain barrier opening - SonoFIRST

This study is for adults newly diagnosed with a specific type of brain cancer called glioblastoma, which has usually been removed by surgery. We are comparing the standard treatments like chemotherapy (temozolomide) and radiotherapy with a new approach. The new method involves using special sound waves to temporarily open the blood-brain barrier. This barrier usually protects the brain but can also stop cancer medicines from getting in effectively. By opening it, we hope more of the medicine can reach the cancer and make the treatment more effective. We also check how people's quality of life is affected.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

04 Dec 2024

Newly diagnosed Glioblastoma (IDH wild-type) patients at initial radiological diagnosis eligible for tumor resection

What is this study about?

This study, called SonoFIRST, is a Phase II clinical trial. This means it's an early-stage study looking at how safe and effective a new treatment approach is. It's designed for people who have recently been diagnosed with a type of brain cancer known as glioblastoma. This particular type is called 'IDH wild-type', and it's usually treated with surgery, followed by a combination of radiotherapy and chemotherapy.

The main idea behind this study is to see if we can help the chemotherapy drugs work better. Our brains have a natural defense system called the 'blood-brain barrier'. While this barrier is very important for protecting our brain from harmful substances, it can also make it difficult for cancer medicines to reach the tumour effectively. In this study, we're exploring if using special sound waves, along with a tiny amount of gas, can gently and temporarily open this barrier.

By opening the blood-brain barrier, we hope that more of the chemotherapy medicine (temozolomide) can get into the brain and reach the cancer cells. This study will compare how well people do with the standard treatment alone versus the standard treatment combined with this new sound wave technique. We're also very interested in how people feel and how their quality of life is affected throughout the treatment.

Key takeaways

This study explores a new way to treat glioblastoma brain cancer.
It uses sound waves to help chemotherapy drugs reach the tumour better.
It compares this new approach with the standard treatment.
Your general health and quality of life are important aspects being monitored.
Participation means regular visits and health checks over many months.

Who may be eligible?

This study is looking for adult patients, aged 18 or older, who have recently been diagnosed with a specific type of brain cancer called glioblastoma. To participate, you would have had surgery to remove the tumour, and your doctors would have confirmed it's the 'IDH wild-type' kind of glioblastoma.

You should also be well enough to receive the standard treatments for this cancer, which include a combination of radiotherapy and chemotherapy. In some centres, standard treatment might also include a device called Tumor Treating Fields, but this is not available everywhere.

Both men and women are welcome to take part in this study. Your medical team will carefully check all the study requirements to make sure it's the right choice for you.

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 recently been diagnosed with glioblastoma (IDH wild-type)?
Have you had surgery to remove your brain tumour?
Are you able to receive standard treatments for glioblastoma (radiotherapy and chemotherapy)?
Are you eligible for follow-up appointments and health checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the standard treatment for glioblastoma or the standard treatment combined with the new sound wave method. The standard treatment typically involves radiotherapy and chemotherapy (temozolomide). You will be given a small amount of a gas and liquid mixture (Luminity) just before the sound wave treatment, if you're in that group. You might also receive another chemotherapy drug called Lomustine later on.

You will have regular hospital visits for check-ups, assessments, and to receive your treatments. This will include blood tests, brain scans, and physical examinations. You'll also be asked to complete questionnaires about your general health, how you're feeling, and your quality of life. These checks will happen at specific times, for example, before your radiotherapy, during chemotherapy cycles, and at several points over many months, potentially up to a year and a half, until your doctors see any signs that the cancer has unfortunately progressed.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new or improved treatments that aren't yet widely available. For this study, the hope is that temporarily opening the blood-brain barrier could make chemotherapy more effective against your glioblastoma. However, there are also potential risks involved, both from the standard treatments and the new sound wave procedure. These could include side effects from the medications or temporary issues related to the sound wave treatment. Your doctors will explain all known side effects and monitor you very closely. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Belgium

Common questions

What is glioblastoma?

Glioblastoma is a serious and fast-growing type of brain tumour. This study focuses on a specific kind, 'IDH wild-type', which is the most common form.

What does 'blood-brain barrier opening' mean?

It's a way to temporarily create tiny, safe openings in the natural protective layer around your brain. This allows medicines to potentially reach the brain tumour more easily.

What is the main goal of this study?

The main goal is to see if opening the blood-brain barrier with sound waves helps chemotherapy work better, slowing down the cancer's growth or recurrence.

Will I know if I'm getting the new treatment or the standard one?

Yes, this is an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving.

How long will I be in the study if I participate?

You'll be monitored with regular visits and assessments potentially for up to 18 months, or until your doctors see signs that the cancer has progressed.