Status:
RECRUITING
Neurocognitive Function After Proton Therapy in Children and Adolescents
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Gert und Susanna Mayer Stiftung
Conditions:
Primary Brain Tumor
Eligibility:
All Genders
8-18 years
Brief 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 ...
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. On...
Eligibility Criteria
Inclusion
- Indication: Patients with primary brain tumor
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04066465
Start Date
September 1 2019
End Date
December 31 2027
Last Update
February 6 2025
Active Locations (3)
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1
University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy
Dresden, Saxony, Germany, 01307
2
University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics
Dresden, Saxony, Germany, 01307
3
University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology
Dresden, Saxony, Germany, 01307