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New hope for kids with brain cancer: less radiation may work just as well

NCT ID NCT02066220

Disease control Sponsor: Universitätsklinikum Hamburg-Eppendorf Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This clinical trial is testing whether lower doses of radiation and chemotherapy can effectively treat children with medulloblastoma, a type of brain tumor, while reducing long-term side effects. The study includes 360 children aged 3 to 21 years with specific tumor types. Researchers are comparing standard treatment to a reduced-intensity approach to see if it maintains survival rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiation therapy and reduced-intensity chemotherapy
What this could lead to
If successful, this could lead to effective treatment with fewer long-term side effects for children with medulloblastoma.
What could go wrong
This is an early-to-mid-stage trial with a small number of participants, so results may not apply to all children. There are risks from radiation and chemotherapy, including potential long-term health issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jun 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 22 years (LR-arm: less than 16 years). The date of diagnosis is the date on which surgery is undertaken. 2. Histologically proven medulloblastoma, including the following subtypes, as defined in the WHO classification (2007): classic medulloblastoma, desmoplastic/nodular medulloblastoma. Pre-treatment central pathology review is considered mandatory. 3. Standard-risk medulloblastoma, defined as; * total or near total surgical resection with less than or equal to 1.5 cm2 (measured on axial plane) of residual tumour on early post-operative MRI, without and with contrast, on central review; * no central nervous system (CNS) metastasis on MRI (cranial and spinal) on central review; * no tumour cells on the cytospin of lumbar CSF * no clinical evidence of extra-CNS metastasis; Patients with a reduction of postoperative residual tumor through second surgery to less than or equal to 1.5 cm2 are eligible, if if timeline for start of radiotherapy can be kept. 4. Submission of high quality biological material including fresh frozen tumor samples for the molecular assessment of biological markers (such as the assessment of myelocytomatosis oncogene (MYC) copy number status) in national biological reference centers. Submission of blood is mandatory for all patients, who agree on germline DNA studies. Submission of CSF is recommended. 5. No amplification of MYC or MYCN (determined by FISH). 6. For LR-arm: Low-risk biological profile, defined as WNT subgroup positivity. The WNT subgroup is defined by the presence of (i) ß-catenin mutation (mandatory testing), or (ii) ß-catenin nuclear immuno-positivity by IHC (mandatory testing) and ß-catenin mutation, or (iii) ß-catenin nuclear immuno-positivity by IHC and monosomy 6 (optional testing). For SR-arm: average-risk biological profile, defined as ß-catenin nuclear immuno-negativity by IHC (mandatory) and mutation analysis (optional). 7. No prior therapy for medulloblastoma other than surgery. 8. Radiotherapy aiming to start no more than 28 days after surgery. Foreseeable inability to start radiotherapy within 40 days after surgery renders patients ineligible for the study. 9. Screening for the compliance with eligibility criteria should be completed, and patient should be included into the study within 28 days after first surgery (in case of second surgery within 35 days after first surgery). Inclusion of patients is not possible later than 40 days after first tumour surgery, or after start of radiotherapy. 10. Common toxicity criteria (CTC) grades \< 2 for liver, renal, haematological function 11. no significant sensorineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing no impairment ≥ 20 decibel (dB) at 1-3 kilohertz (kHz). If performance of pure tone audiometry is not possible postoperatively, normal otoacoustic emissions are acceptable, if there is no history for hearing deficit. 12. No medical contraindication to radiotherapy or chemotherapy, such as preexisting DNA breakage syndromes (e.g. Fanconi Anemia, Nijmegen breakage syndrome), Gorlin Syndrome or other reasons as defined by patient's clinician. 13. No identified Turcot and Li Fraumeni syndrome. 14. Written informed consent (and patient assent where appropriate) for therapy according to the laws of each participating country. Information must be provided to the patient on biological studies (tumour and germline), and written informed consent obtained of agreement for participation. 15. National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies). Exclusion Criteria: 1. One of the inclusion criteria is lacking. 2. Brainstem or supratentorial primitive neuro-ectodermal tumour. 3. Atypical teratoid rhabdoid tumour. 4. Medulloepithelioma; Ependymoblastoma 5. Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), centrally confirmed. 6. Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or MYC or MYCN or WNT subgroup status not determinable. 7. Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF). 8. Patient previously treated for a brain tumour or any type of malignant disease. 9. DNA breakage syndromes (e.g. Fanconi anemia, Nijmegen breakage syndrome) or other, or identified Gorlin,Turcot, or Li Fraumeni syndrome. 10. Patients who are pregnant. 11. Female patients who are sexually active and not taking reliable contraception. 12. Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons. 13. Patients in whom non-compliance with toxicity management guidelines can be expected.

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm medulloblastoma Neuroectodermal Tumors, Primitive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain tumors

Contacts and locations

Locations

  • Angelika-Lautenschläger-Klinik

    Heidelberg, 69120, Germany

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757, Germany

  • Barncancercentrum Drottning Silvias Barnochungdomssjukhus

    Göteburg, 41685, Sweden

  • CHU de Grenoble

    Grenoble, 38045, France

  • CHU-TOURS - Hôpital Clocheville

    Tours, 37044, France

  • Carl-Thiem-Klinikum Cottbus

    Cottbus, 03048, Germany

  • Charite Campus, University of Berlin

    Berlin, 13353, Germany

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419, Germany

  • Dr. Horst Schmidt Kliniken

    Wiesbaden, 65199, Germany

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, 33617, Germany

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133, Italy

  • Gemeinschaftsklinikum Koblenz-Mayen

    Koblenz, 56073, Germany

  • Gemeinschaftskrankenhaus Herdecke

    Herdecke, 58313, Germany

  • Great Ormond Street Hospital

    London, WC1N 3JH, United Kingdom

  • HELIOS Klinikum Krefeld

    Krefeld, 47805, Germany

  • HELIOS Klinikum-Erfurt

    Erfurt, 99089, Germany

  • HELIOS-Kliniken Schwerin

    Schwerin, 19049, Germany

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Hôpital NANCY-BRABOIS

    Vandœuvre-lès-Nancy, 54500, France

  • Institute Curie

    Paris, 75231, France

  • Johannes Wesling Klinikum Minden

    Minden, 32429, Germany

  • Kliniken der Stadt Köln

    Cologne, 50735, Germany

  • Klinikum Augsburg

    Augsburg, 86156, Germany

  • Klinikum Braunschweig

    Braunschweig, 38118, Germany

  • Klinikum Bremen-Mitte

    Bremen, 28177, Germany

  • Klinikum Chemnitz

    Chemnitz, 09116, Germany

  • Klinikum Dortmund

    Dortmund, 44137, Germany

  • Klinikum Duisburg

    Duisburg, 47055, Germany

  • Klinikum Kassel

    Kassel, 34125, Germany

  • Klinikum Oldenburg

    Oldenburg, 26133, Germany

  • Klinikum Schwabing, Pediatric Hospital of Technical University

    München, 80804, Germany

  • Klinikum Stuttgart

    Stuttgart, 70176, Germany

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, 38440, Germany

  • Medical University of Graz

    Graz, 8010, Austria

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Mutterhaus der Borromäerinnen

    Trier, 54290, Germany

  • Oncology Hospital Cruces Bilbao

    Barakaldo, 48903, Spain

  • Our Lady's Children's Hospital

    Dublin, 12, Ireland

  • Prinses Máxima Center for Pediatric Oncology

    Bilthoven, 3720, Netherlands

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Rigshospitalet

    Oslo, 0424, Norway

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133, Germany

  • The Children's Memorial Health Institute

    Warsaw, 04-730, Poland

  • UK-SH Campus Kiel

    Kiel, 24105, Germany

  • University Children's Hospital

    Zurich, 8032, Switzerland

  • University Hospital Aachen

    Aachen, 52074, Germany

  • University Hospital Bonn

    Bonn, 53113, Germany

  • University Hospital Brno

    Brno, 61300, Czechia

  • University Hospital Cologne

    Cologne, 50924, Germany

  • University Hospital Dresden

    Dresden, 01307, Germany

  • University Hospital Düsseldorf

    Düsseldorf, 40225, Germany

  • University Hospital Erlangen

    Erlangen, 91054, Germany

  • University Hospital Essen

    Essen, 45147, Germany

  • University Hospital Frankfurt/Main

    Frankfurt, 60590, Germany

  • University Hospital Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University Hospital Gasthuisberg

    Leuven, 3000, Belgium

  • University Hospital Gießen and Marburg

    Giessen, 35392, Germany

  • University Hospital Greifswald

    Greifswald, 17475, Germany

  • University Hospital Göttingen

    Göttingen, 37075, Germany

  • University Hospital Halle/Saale

    Halle, 06120, Germany

  • University Hospital Homburg/Saar

    Homburg, 66421, Germany

  • University Hospital Jena

    Jena, 07740, Germany

  • University Hospital Leipzig

    Leipzig, 04103, Germany

  • University Hospital Lübeck

    Lübeck, 23538, Germany

  • University Hospital Magdeburg

    Magdeburg, 39120, Germany

  • University Hospital Mainz

    Mainz, 55131, Germany

  • University Hospital Mannheim

    Mannheim, 68167, Germany

  • University Hospital München, Dr. von Haunersches Kinderspital

    München, 80337, Germany

  • University Hospital Münster

    Münster, 48149, Germany

  • University Hospital Regensburg

    Regensburg, 93053, Germany

  • University Hospital Rostock

    Rostock, 18057, Germany

  • University Hospital S.Joao

    Porto, 4200, Portugal

  • University Hospital Tübingen

    Tübingen, 72076, Germany

  • University Hospital Ulm

    Ulm, 89075, Germany

  • University Hospital Würzburg

    Würzburg, 97080, Germany

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Vestische Kinder- und Jugendklinik, University Witten/Herdecke

    Datteln, 45711, Germany

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