AuthorisedTherapeutic confirmatory (Phase III)Interventional

Comparison of neurocognitive outcome in two standard regimen for treatment of low-risk medulloblastoma (COGNITO-MB)

This study, called COGNITO-MB, is for children newly diagnosed with a specific type of brain cancer called medulloblastoma. Doctors want to compare two standard treatment plans to see how they impact a child's thinking and learning skills (neurocognitive outcome). They will measure this using special tests like the WPPSI-IV or WISC-V at different times after diagnosis. The study also tracks how long children live without their cancer coming back, overall survival, and any side effects from treatment. This research aims to understand which standard treatment is best for preserving brain function in these young patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

GPOH gGmbH

Enrolment target

Start

26 Aug 2025

newly diagnosed non-metastatic SHH-activated non-MYC amplified medulloblastoma

What is this study about?

This study is called COGNITO-MB, and it's looking at children who have recently been diagnosed with a type of brain cancer called medulloblastoma. Specifically, it's for a particular kind of medulloblastoma that doctors describe as "low-risk." The main goal of the study is to compare two common treatment plans for this cancer. Doctors want to understand how these treatments affect a child's thinking, learning, and memory skills, which they call neurocognitive outcome.

To do this, they will use special tests, like the WPPSI-IV, which is designed for young children, or the WISC-V, for older children. These tests help measure a child's overall intelligence and different aspects of their brain function. The researchers will give these tests at specific times, for example, about two and a half years after a child is diagnosed with cancer. The study is important because treating brain cancer in children can sometimes affect how their brains develop and work, and doctors want to find the best way to treat the cancer while also protecting their brain health.

Besides looking at thinking and learning, the study will also track other important things. This includes how long children stay free of cancer, how long they live overall, and if they develop any other health problems or side effects from the treatment. By carefully comparing the two standard treatment plans, doctors hope to learn which approach leads to the best outcomes for children with this type of medulloblastoma, helping them live longer and healthier lives with good brain function.

Key takeaways

This study compares standard brain cancer treatments for young children.
It focuses on how treatments affect thinking and learning abilities.
The study includes children recently diagnosed with a specific 'low-risk' medulloblastoma.
Special tests will measure brain function at different times after diagnosis.
The goal is to find the best balance between treating cancer and protecting brain health.

Who may be eligible?

This study is designed for children who have just been diagnosed with a specific type of brain cancer called medulloblastoma. It's for those with medulloblastoma that is considered "low-risk" and hasn't spread to other parts of the body. There are also specific features of the cancer cells themselves that doctors will check to see if a child's cancer matches what the study is looking for.

There are no age limits for joining the study, meaning it's open to children of all ages, from toddlers to teenagers, as long as they meet the other specific criteria for their cancer. Children of any gender can participate.

Your child's doctor will need to perform tests on the cancer tissue to confirm if it has certain characteristics that make them suitable for this study. These special characteristics help doctors group similar cancers together for research.

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.

My child has been newly diagnosed with medulloblastoma.
My child's medulloblastoma is considered 'low-risk' and has not spread.
My child's specific cancer cells match what the doctors are looking for (this will be confirmed by tests).
My child can participate in special thinking and learning tests.

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will receive one of two standard treatment plans for medulloblastoma, which include a combination of different medications. These medications are given in cycles, and the specific schedule will be explained by your child's medical team.

Throughout the study, your child will have regular check-ups, scans, and blood tests to monitor their health, the cancer's response to treatment, and any side effects. A key part of the study involves special thinking and learning tests (like the WPPSI-IV or WISC-V) at different times, such as about two and a half years and five years after diagnosis. These tests help doctors understand the long-term effects of treatment on your child's brain development. The study will continue to follow your child for several years to track their progress and overall health, even after treatment has finished.

Potential risks and benefits

Participating in this study means your child will receive one of the standard, established treatments for their type of medulloblastoma. The potential benefit is that doctors will gain a better understanding of how these treatments affect children's long-term brain function, which could help future patients. However, like all cancer treatments, there are potential risks, including side effects from the medications, which your child's medical team will discuss in detail. Your child will also need to undergo additional tests, such as intelligence assessments, as part of the study. You have the right to withdraw your child from the study at any time, for any reason, without affecting their medical care.

Locations (5)

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

—
Unverified
France
—
Unverified
Denmark
—
Unverified
Germany
—
Unverified
Belgium
—
Unverified
Netherlands

Common questions

What kind of cancer is medulloblastoma?

Medulloblastoma is a type of brain tumour that typically starts in the lower back part of the brain called the cerebellum.

What does 'low-risk' medulloblastoma mean?

Low-risk means that based on certain features, the cancer is thought to be less aggressive or has a better chance of responding to standard treatments.

What does neurocognitive outcome mean?

Neurocognitive outcome refers to how well a child's brain functions in terms of thinking, learning, memory, problem-solving, and other mental abilities.

Will my child definitely get better if they join this study?

No study can guarantee a specific outcome. This study is comparing existing standard treatments to understand their effects better, but it doesn't offer a new, unproven treatment.

What are the common side effects of these treatments?

The treatments involve chemotherapy, which can have side effects like feeling sick, tiredness, hair loss, and a weaker immune system. Your child's doctor will discuss the specific risks in detail.