Belvarafenib for CNS Efficacy in Patients With BRAF-Altered Solid Tumors
NCT07688356
Brain Diseases, Brain Neoplasms
Seoul, South Korea
View Trial DetailsNCT Number: NCT04066465
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.
Interested in participating?
Request Info8 year–18 year
All sexes
Observational
University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy, Dresden, Saxony, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Indication: Patients with primary brain tumor
Inclusion criteria
Exclusion criteria
Time frame: 2 years
Neurophysiological processes are examined while subjects perform the cognitive tests.
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/)
Time frame: 2 years
physical doses to substructures of the brain are collected and correlated with neurophysiological outcome measures
Contact information is provided by the study sponsor or research team.
Technische Universität Dresden
Other
Neurocognitive Function /executive Functions After Proton Therapy in Children and Adolescents.
Acronym: ELBE-ProKids
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