Neurocognitive Function After Proton Therapy in Children and Adolescents

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	8 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04066465
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Technische Universität Dresden
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mechthild Krause, Prof. Dr.
Principal Investigator Affiliation	University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.