Neurocognitive Function After Proton Therapy in Children and Adolescents

Primary Brain Tumor Clinical Trial

— ELBE-ProKids  

Official title:

Neurocognitive Function /Executive Functions After Proton Therapy in Children and Adolescents.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066465
• Other study ID #: STR-ELBE-Pro-Kids-2019
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: Mechthild Krause, Prof. Dr.
• Phone: +49 351 458 2238
• Email: mechthild.krause[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Indication: Patients with primary brain tumor

Inclusion Criteria:

• 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,

• 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)

Exclusion Criteria:

• 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.

• 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

Related Conditions & MeSH terms

• Brain Neoplasms
• Primary Brain Tumor

Locations

Country	Name	City	State
Germany	University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy	Dresden	Saxony
Germany	University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics	Dresden	Saxony
Germany	University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Gert und Susanna Mayer Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurophysiological correlates of cognitive control (ERP amplitude measures, spectral power measures)	Neurophysiological processes are examined while subjects perform the cognitive tests.	2 years
Primary	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/)	2 years
Secondary	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	2 years