Active not recruitingPHASE2, PHASE3INTERVENTIONAL

International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma

This research trial, called PNET 5 Medulloblastoma, is for children and young people aged 3 to 21 with a type of brain tumour called medulloblastoma. Doctors are comparing different treatment plans, mainly involving radiotherapy (radiation therapy) and chemotherapy (medication), to see which works best for different types of this tumour based on its biological features. The study is split into different groups depending on the tumour's characteristics, such as WNT-activated or SHH-TP53 mutations. The main goals are to improve the success rate of treatment and potentially reduce side effects by tailoring the therapy. This study will help doctors understand how to give the most effective treatment for each patient.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

360

Start

01 Jun 2014

Estimated completion

01 Dec 2026

Brain Tumors

What is this study about?

This study, called PNET 5 Medulloblastoma, is designed for children and young people who have been diagnosed with a type of brain tumour called medulloblastoma. The main goal is to find better ways to treat this condition. Researchers are comparing different combinations of treatments, primarily using radiotherapy (which uses high-energy rays to kill cancer cells) and chemotherapy (which uses powerful medicines to destroy cancer cells).

What makes this study special is that it groups patients based on the specific biological characteristics of their tumour. Doctors now know that not all medulloblastomas are the same, and they have different genetic features. By understanding these features, the study aims to tailor treatment so that each patient receives the most effective therapy for their particular tumour type. For example, some children might have a 'low-risk' type of tumour (WNT-activated) and might get slightly less intense treatment, while others with different features might receive a more robust approach.

The study is divided into different arms (sections) based on these tumour characteristics. Some arms are looking at maintaining a good recovery rate, while others are trying to improve the outcome for more challenging types of the tumour. Ultimately, this research helps doctors learn how to give the best possible care, aiming for successful treatment outcomes while trying to keep side effects to a minimum.

Key takeaways

This study treats a type of brain tumour called medulloblastoma in children and young people.
Treatment plans combine radiotherapy and chemotherapy, tailored to a tumour's specific features.
The goal is to improve treatment success and reduce side effects by customising therapy.
Patients get regular check-ups and scans to monitor their progress.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, children and young people generally need to be between 3 and 21 years old when they are diagnosed with medulloblastoma. The doctors will also need to confirm that the tumour is a specific type of medulloblastoma, as defined by the World Health Organization classification.

Critically, the tumour must be considered 'standard-risk' meaning it hasn't spread to other parts of the brain or spinal cord, and surgeons have been able to remove most, if not all, of it. There should also be no signs of the cancer having spread outside the brain and spinal cord. Doctors will carefully check MRI scans and fluid from around the brain and spinal cord to confirm this.

Another key part of deciding if someone can join is looking at the tumour's detailed biology. This involves testing samples of the tumour to find out its specific genetic characteristics, such as whether it's 'WNT-activated' or has other particular features. These biological markers help doctors decide which treatment group in the study would be most suitable.

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.

Is the patient aged between 3 and 21 years?
Has the patient been diagnosed with medulloblastoma?
Has the tumour been confirmed as 'standard-risk' and not spread widely?
Are there tumour samples available for special biological testing?
Are there no signs of the cancer having spread outside the brain/spine?

Answer every question to see your result.

What does participation involve?

If a child or young person joins this study, they will receive treatment based on their specific type of medulloblastoma. This will typically involve radiotherapy, which is usually given once a day for a period, followed by chemotherapy. The chemotherapy involves cycles of different medications, which will be given over several months. The exact type and number of chemotherapy cycles will depend on which study group they are in.

Throughout the study, patients will have regular check-ups, including MRI scans, to monitor the tumour and assess how well the treatment is working. They will also have blood tests and other assessments to check their general health and manage any side effects. Doctors will also collect tumour samples for detailed biological analysis. The total duration of treatment and follow-up will vary depending on the specific study arm and individual patient needs, but generally, the chemotherapy phase itself can last several months.

Potential risks and benefits

Taking part in this study means you or your child will receive advanced treatment for medulloblastoma, which could potentially offer a better outcome than standard treatments, especially by tailoring therapies to the tumour's specific characteristics. However, as with any medical treatment, there are potential risks and side effects associated with radiotherapy and chemotherapy, such as fatigue, nausea, hair loss, and changes to blood counts. Doctors will monitor these carefully and manage them as best they can. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without it affecting the standard medical care you or your child would otherwise receive.

Locations (77)

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

Medical University of Graz
Verified postcode
Graz, Austria
University Hospital Gasthuisberg
Verified postcode
Leuven, Belgium
University Hospital Brno
Verified postcode
Brno, Czechia
Rigshospitalet
Verified postcode
Copenhagen, Denmark
CHU de Grenoble
Verified postcode
Grenoble, France
Institute Curie
Verified postcode
Paris, France
CHU-TOURS - Hôpital Clocheville
Verified postcode
Tours, France
Hôpital NANCY-BRABOIS
Verified postcode
Vandœuvre-lès-Nancy, France
University Hospital Aachen
Verified postcode
Aachen, Germany
Klinikum Augsburg
Verified postcode
Augsburg, Germany
Helios Klinikum Berlin-Buch
Verified postcode
Berlin, Germany
Charite Campus, University of Berlin
Verified postcode
Berlin, Germany

Common questions

What is medulloblastoma?

Medulloblastoma is a type of cancerous brain tumour that starts in the cerebellum, the back part of the brain that controls balance and coordination.

Why are there different treatment groups?

Doctors have learned that medulloblastoma has different characteristics, so treatments are being tailored. Different groups receive slightly different plans to see which works best for each type.

What does 'radiotherapy' mean?

Radiotherapy uses high-energy rays, similar to X-rays, to kill cancer cells and shrink tumours in the body.

What does 'chemotherapy' mean?

Chemotherapy uses special medicines, often given as injections or pills, to kill cancer cells throughout the body.

Can I leave the study if I change my mind?

Yes, joining the study is completely voluntary. You can decide to leave the study at any time, and it will not affect the medical care you or your child receives.