Comparing two treatment regimens with drug combination for newly diagnosed low-risk medulloblastoma to evaluate cognitive function outcomes

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What is this study about?

This clinical trial focuses on studying medulloblastoma, specifically the non-metastatic, SHH-activated type in young patients. Medulloblastoma is a type of brain tumor that typically develops in children. The study aims to compare brain function outcomes between two different treatment approaches.

The treatment involves several chemotherapy medications including methotrexate, etoposide, cyclophosphamide, carboplatin, vincristine, cisplatin, and thiotepa. These medications will be given through different methods, including directly into the bloodstream through a vein and, in some cases, directly into areas around the brain.

The study will track how well children’s thinking and learning abilities develop over time after receiving treatment. Doctors will measure these abilities through various tests when the treatment starts and continue monitoring for several years afterward. They will also check for any hearing problems and changes in brain tissue that might occur as a result of the treatment.

1 Initial assessment

Your diagnosis will be confirmed as medulloblastoma (a type of brain tumor) that meets specific medical criteria

You will be randomly assigned to one of two treatment groups: Group A (‘Head Start’ 4) or Group B (HITSKK)

2 Treatment administration

You will receive medications through intravenous (into the vein) administration

The medications include: methotrexate (given both intravenously and through the brain fluid), etoposide, cyclophosphamide, carboplatin, vincristine, cisplatin, and thiotepa

3 Initial evaluation

Your mental abilities will be assessed using age-appropriate tests

Quality of life questionnaires will be completed

Hearing tests will be performed

4 2.5-year follow-up

Mental ability tests will be repeated

Quality of life assessment will be conducted

Hearing evaluation will be performed

Brain imaging will be done to check for any white matter changes

5 5-year follow-up

Final set of mental ability tests will be conducted

Quality of life will be assessed again

Final hearing evaluation will be performed

Brain imaging will be repeated to check for any changes

Who Can Join the Study?

  • Child must be under 5 years old at the time of diagnosis
  • Child must have suspected or confirmed SHH-activated medulloblastoma (a specific type of brain tumor) as determined by the medical facility
  • Family must be able to commit to regular follow-up appointments for brain function testing
  • Parents or legal guardians must be able to understand the study information and provide written consent for screening procedures
  • Both the child and parents/legal guardians must be willing and able to participate in the entire duration of the study if the child qualifies
  • Both male and female children can participate in the study
  • Family must have stable living circumstances that allow for consistent participation in the study

Who Cannot Join the Study?

  • Prior treatment with chemotherapy, radiotherapy or other anti-cancer therapy (except for surgery)
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Having a TP53 mutation (a specific genetic change in tumor cells)
  • Having MYC gene amplification (increased copies of a specific cancer-related gene)
  • Presence of other types of brain tumors not classified as SHH-activated medulloblastoma
  • Severe medical conditions that could interfere with study treatment
  • Inability to undergo required medical procedures or tests
  • Active infections that require treatment
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within 30 days before starting this study
  • Known allergies or hypersensitivity to study medications
  • Mental conditions that could affect the ability to follow study requirements

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Medizinische Hochschule Hannover Hanover Germany
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Klinikum Dortmund gGmbH Dortmund Germany
HELIOS Klinikum Krefeld GmbH Krefeld Germany
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Johannes Wesling Klinikum Minden Minden Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
University Childrens Hospital Queen Fabiola Brussels Belgium
Odense University Hospital Odense Denmark
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Kliniken der Stadt Koeln gGmbH Cologne Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum Kassel GmbH Kassel Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
CHC MontLegia Liege Belgium
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Curmfihjq Udatkwgifmjrsn Snhmmipjr Woluwe-Saint-Lambert Belgium
Ugllorbxkg Mjwbpja Csotjo Hdzadiegmoqzvabaw Hamburg Germany
Ugrwqslnpltwpqzncsvjr Ewfhw Ajh Essen Germany
Mgakkxkazivwzlymfybwtxqlwc Hkbqhhbloexwaxfd Halle (Saale) Germany
Uvjrhgjycahbpjtwbgqix Atetqveg Augsburg Germany
Sgcz Keuigxiv Dzqdstvk Gvqk Duisburg Germany
Ubkvoxusoq Hnotuhmp Coqdope Cologne Germany
Ulmxvvozybuaqwjvtpxvi Djwkdtbkqdb Alj Duesseldorf Germany
Uaufzxpldp Ow Ajtbglr Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.07.2025
Denmark Denmark
Not yet recruiting
01.07.2025
France France
Not yet recruiting
01.07.2025
Germany Germany
Not yet recruiting
01.07.2025
The Netherlands The Netherlands
Not yet recruiting
01.07.2025

Trial locations

Based on the provided data, I cannot identify specific medications or therapies, as the trial information doesn’t explicitly list the treatments. The trial appears to be comparing two standard treatment regimens for medulloblastoma (HITSKK and Head Start 4), but without detailed medication information in the source data, I cannot provide specific descriptions of medications or therapies involved.

If you could provide additional data about the specific medications or therapies used in either the “Head Start 4” or “HITSKK” treatment protocols, I would be happy to describe them according to the requested format.

Investigated diseases:

Medulloblastoma – A brain tumor that starts in the cerebellum, the part of the brain that controls balance and coordination. It develops from primitive or embryonic cells that remain in the brain after birth. The tumor typically forms in the lower back part of the brain and can spread to other parts of the brain and spinal cord through the cerebrospinal fluid. Medulloblastoma grows relatively quickly and can interfere with normal brain function, affecting movement, balance, and other basic functions.

Gorlin Syndrome – A genetic condition that affects multiple systems in the body, also known as Basal Cell Nevus Syndrome. People with this condition are born with abnormalities in multiple body parts and tend to develop various types of tumors. The syndrome causes distinctive facial features, multiple small skin growths, and skeletal abnormalities. It can also lead to the development of jaw cysts and calcification in various parts of the brain.

Leukoencephalopathy – A condition that affects the white matter of the brain, characterized by deterioration of the brain’s white matter. The white matter contains nerve fibers that are covered by myelin, which helps transmit signals in the brain. This condition can develop gradually and affects how different parts of the brain communicate with each other. It can impact various brain functions including movement and thinking abilities.

Trial ID:
2024-517133-40-00
Protocol code:
COGNITO-MB
Trial Phase:
Therapeutic confirmatory (Phase III)

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