Neurocognitive Function After Proton Therapy in Children and Adolescents

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT04066465

Studienbeginn:
September 2019

Letztes Update:
20.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
Gert und Susanna Mayer Stiftung

Studienleiter

Mechthild Krause, Prof. Dr.
Study Chair
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Kontakt

Mechthild Krause, Prof. Dr.
Kontakt:
Phone: +49 351 458 2238
E-Mail: mechthild.krause@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christian Beste, Prof. Dr.» Ansprechpartner anzeigen

University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maja von der Hagen, Prof. Dr.» Ansprechpartner anzeigen

University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mechthild Krause, Prof. Dr.» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Neurophysiological correlates of cognitive control (ERP amplitude measures, spectral power measures) (Time Frame - 2 years):
Neurophysiological processes are examined while subjects perform the cognitive tests.

2. Quality of Life Parameters (KINDL®) (Time Frame - 2 years):
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/)

Secondary outcome:

1. dose-volume parameters to normal tissues, i.e. maximum irradiation doses, mean doses and doses to subvolumes (Time Frame - 2 years):
physical doses to substructures of the brain are collected and correlated with neurophysiological outcome measures

Studien-Arme

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 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.
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.

Quelle: ClinicalTrials.gov

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