Neurocognitive Function After Proton Therapy in Children and Adolescents

NCT ID: NCT04066465

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2027-12-31

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 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.

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.

Conditions

Primary Brain Tumor

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Proton Therapy

Patients 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 interventions assigned to this group

No Radiotherapy - Surgical only group

Patients 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.

No interventions assigned to this group

Control Group

Healthy 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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gert und Susanna Mayer Stiftung

UNKNOWN

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mechthild Krause, Prof. Dr.

Role: STUDY_CHAIR

University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Locations

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

Dresden, Saxony, Germany

Site Status: RECRUITING

University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics

Dresden, Saxony, Germany

Site Status: RECRUITING

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

Dresden, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Mechthild Krause, Prof. Dr.

Role: CONTACT

mechthild.krause@uniklinikum-dresden.de

+49 351 458 2238

Facility Contacts

Christian Beste, Prof. Dr.

Role: primary

Maja von der Hagen, Prof. Dr.

Role: primary

Mechthild Krause, Prof. Dr.

Role: primary

Other Identifiers

STR-ELBE-Pro-Kids-2019

Identifier Type: -

Identifier Source: org_study_id