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Primary Brain TumorELBE-ProKidsNCT04066465

Neurocognitive Function After Proton Therapy in Children and Adolescents

An observational study of Primary Brain Tumor, run by Technische Universität Dresden at 3 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted/analysed/evalutated. Read more about this study

Who is it for?
Ages 8 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Primary Brain Tumor
How many people
90 participants
Where
3 sitesGermany
Study dates
1 Sep 2019to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: 30 patients with infra-tentorial or supra-tentorial tumors undergoing proton therapy, 30 patients undergoing surgical treatment and a control cohort of 30 adolescents. Therefore, a total of 90 persons will be evaluated.

Who may be able to join

  • all groups: Patients in childhood and adolescence between 8-18 years of age
  • all groups: no prior radiotherapy of the brain,
  • all groups: The patient is able to perform repeated neuropsychological tests (approx. 1 hour per examination),
  • all groups: corrected visual acuity not impaired below 80% or no subjective indication of visual acuity impairment,
  • all groups: corrected hearing not impaired or no subjective evidence of hearing impairment,
  • all groups: Patient is able to perform follow-up examinations,
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  • all groups: written consent of the patient/parent or guardian.
  • Brain tumour groups with/without irradiation: Primary brain tumour
  • brain tumor groups with/without radiation: curative or long-term palliative intention of therapy
  • brain tumor groups with/without irradiation: life expectancy > 3 years
  • Irradiation group only: planned proton therapy with a local radiation dose of at least 40 Gy(RBE)

Who cannot join

  • Patients under 8 or over 18 years of age (We limit the study to children over 8 years of age due to the fact that executive functions mature very late.)
  • Brain metastases from extracerebral tumors
  • Patient receives intrathecal chemotherapy
  • pure palliative treatment concept
  • The patient is not able to perform repeated neuropsychological tests (approx. 1 hour per examination).
  • Chronic diseases that may affect the results of neurological EEG and neuropsychological examinations.
Show all 9Show fewer
  • The patient is not in a position to perform follow-up examinations
  • no written consent of the patient / parent or legal guardian
  • Participation in an intervention study whose procedures contradict those of the present study

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mechthild Krause, Prof. Dr. contact

+49 351 458 2238

mechthild.krause@uniklinikum-dresden.de

Germany3 sites, 3 recruiting

  • University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy

    Dresden, Saxony, 01307

    Christian Beste, Prof. Dr.

    Recruiting

  • University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics

    Dresden, Saxony, 01307

    Maja von der Hagen, Prof. Dr.

    Recruiting

  • University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology

    Dresden, Saxony, 01307

    Mechthild Krause, Prof. Dr.

    Recruiting

Other trials in Germany

About this study

Official title: Neurocognitive Function /executive Functions After Proton Therapy in Children and Adolescents.

Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted/analysed/evalutated. In a second step, these results are to be compared with

  1. a group of children and adolescents who had only /exclusively had operative therapy and
  2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive/neurophysiology brain research approaches are applied that may potentially visualize even small / subtle changes in mental activities/neurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.
Read the detailed description

Radio(chemo)therapy with protons is conducted according to current treatment standards or, for patients participating in a clinical intervention study, according to the study protocols of the GPOH. Only patients with prescribed radiation doses > 40 Gy (RBE) will be included. Treatment planning, the target volume and radiotherapy will be performed according to the current treatment standards. For patients participating in a clinical intervention study, radiotherapy is corresponding to study protocol of the GPOH. Risk organs (e.g. brain stem, chiasma, optic nerves, gll. Lacrimals, lenses, inner ears and spine) are contoured and the radiation doses for these organs are limited according to institutional guidelines. Radiotherapy is performed according to guidelines, i.e. 5 days a week for 4-6 weeks, usually on an outpatient basis.

Keywords
Brain Tumor, children and adolescents, neurocognitive function, neurocognitive or neuropsychological outcome, quality of life, LOQ, EEG, Neuropsychological Tests, Proton Therapy, Neurosurgical Treatment
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04066465
Study groupRoleWhat they receive
Proton TherapyPatients receive proton Radio(chemo)therapy according to clinical standard. Proton Treatment is indicated BEFORE inclusion into the trial ans is not part of the trial. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely during follow-up using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases. In addition to the treatment parameters of the radio(chemo)therapy protocol, further radiation doses to brain substructures and organs at risk are documented.
No Radiotherapy - Surgical only groupPatients are included AFTER surgery of their brain tumour and receive no radiotherapy due to their disease (i.e. according to clinical standard). This Treatment is not part of the trial, but stratifies the Patient in this second Group. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely during follow-up using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases.
Control GroupHealthy kids are recruited as Standard Group. Neurological status and neurocognitive testing on core executive functions (inhibition, working memory, cognitive flexibility) and Quality of life measurements are performed regularely using standardized KINDL® questionnaires for general quality of life and specific for oncologic diseases.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurophysiological correlates of cognitive control (ERP amplitude measures, spectral power measures)

    Neurophysiological processes are examined while subjects perform the cognitive tests.

    Measured: 2 years

  2. Quality of Life Parameters (KINDL®)

    QoL Parameters are measured and reported using KINDL® questionnaires for general quality of life and specific for oncologic diseases (also KINDL®). Scales for QoL items are 0-100 (with 100 being the Optimum, i.e. lower values indicating worse outcome). Evaluation is performed according to the standard published with the validated questionnaires (https://www.kindl.org/deutsch/fragebögen/)

    Measured: 2 years

Secondary outcomes (1)

  1. dose-volume parameters to normal tissues, i.e. maximum irradiation doses, mean doses and doses to subvolumes

    physical doses to substructures of the brain are collected and correlated with neurophysiological outcome measures

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start1 Sep 2019
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066465
Sponsor's protocol ID
STR-ELBE-Pro-Kids-2019
Acronym
ELBE-ProKids
Status last verified
Feb 2025
First submitted
19 Jun 2019
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Brain Tumor, run by Technische Universität Dresden at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mechthild Krause, Prof. Dr. (+49 351 458 2238, mechthild.krause@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurophysiological correlates of cognitive control (ERP amplitude measures, spectral power measures) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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