Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

EORTC 1634-BTG (NOA-23): Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly Diagnosed Medulloblastoma (PersoMed-I)

This study, called PersoMed-I, is for adults diagnosed with médulloblastoma, a type of brain cancer. It's looking at whether a new, more personalised treatment approach is better than the current standard treatment. The main goal is to see if patients live longer without their cancer coming back or getting worse. Researchers will also look at overall survival, side effects, and how the treatment affects patients' general well-being and brain function. This is a "Phase II" study, meaning it's exploring if the new treatment works well enough to be tested on a larger scale. Participants will receive either the new personalised treatment or the standard one.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

European Organisation For Research And Treatment Of Cancer

Enrolment target

Start

02 Jul 2024

Newly Diagnosed Medulloblastoma

What is this study about?

This research study, called PersoMed-I, is focused on finding better ways to treat adult patients who have recently been diagnosed with médulloblastoma. This is a type of cancer that starts in a part of the brain. The study is particularly interested in patients whose cancer has a specific genetic marker called "SHH-activated standard risk." The aim is to personalise treatment as much as possible, which means tailoring it to the individual patient and their specific cancer type.

In this study, doctors want to compare a new, personalised treatment approach with the standard treatment that is currently given. They will be looking closely to see if patients who receive the new personalised treatment live longer without their cancer growing or spreading. They'll also be tracking other important things like how long patients live overall, what side effects they might experience, and how the treatment affects their daily life and thinking abilities. The hope is that this new approach could lead to more effective and potentially kinder treatments for people with médulloblastoma.

It's important to understand that this is a "Phase II" study. This means it's an early stage of clinical research where doctors are exploring if the new treatment is safe and shows promise. It's a key step towards potentially making this new approach available more widely in the future. By participating, patients contribute valuable information that can help improve treatments for others with médulloblastoma.

Key takeaways

This study is for adults with newly diagnosed médulloblastoma.
It compares a new 'personalised' treatment to the standard treatment.
The main goal is to see if the new treatment helps people live longer without their cancer growing.
Researchers will also track side effects and quality of life.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults of any age (18 years and older) who have recently received a diagnosis of médulloblastoma. Both men and women can take part.

To be considered for this study, your doctor will need to confirm that your specific type of médulloblastoma is classified as "SHH-activated standard risk." This is a detailed medical check that identifies certain characteristics of your cancer.

There might be other health requirements or conditions that would prevent you from joining the study, which your doctor will discuss with you. It's always best to have a conversation with your doctor or the study team to see if this particular study is a good fit for your situation.

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 médulloblastoma?
Has your doctor confirmed your médulloblastoma is 'SHH-activated standard risk'?
Are you able to attend regular hospital visits and follow the study instructions?
Are you comfortable with the possibility of receiving either a new or standard treatment?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first undergo some assessments to confirm you meet all the criteria. You would then be randomly assigned to receive either the new personalised treatment or the standard treatment currently used for médulloblastoma. The treatment will involve specific medications like Lomustine, Sonidegib (also known as Odomzo), Vincristine, and Cisplatin, which will be given according to a set schedule. Doctors will carefully monitor you throughout your treatment, which will include regular check-ups, scans, blood tests, and assessments to track your brain function and general well-being. They will be looking for any signs of the cancer returning or progressing, and also monitoring for side effects. You will also be asked to complete questionnaires about your quality of life and how you're feeling. This study involves ongoing follow-up for a significant period to understand the long-term effects of the treatments. Your doctor will be able to provide a much more detailed schedule of visits and the total expected duration of your participation.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new and potentially improved treatments before they are widely available. You will also receive careful monitoring by a team of medical experts. However, there are also potential risks; the new treatment might not work as hoped, or it could cause side effects that are not yet fully understood. These side effects can range from mild to serious, similar to those experienced with standard cancer treatments. Your doctor will explain all known risks associated with the medications used. It's very important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is médulloblastoma?

Médulloblastoma is a type of cancer that starts in the brain, often in a part called the cerebellum.

What does 'personalised treatment' mean?

It means the treatment is tailored based on specific features of your cancer, aiming to make it more effective for you.

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

In some studies, participants know which treatment they are getting, while in others, they don't. The study team will explain how this works for PersoMed-I.

What are 'side effects'?

Side effects are unwanted reactions or problems that can happen from cancer treatments, like feeling sick or tired.

Can I stop participating in the study at any time?

Yes, you have the right to leave the study at any point, and it won't affect your regular medical care.