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NCT05727605
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Conditions: Cognition, Brain Tumor, Magnetic Resonance Imaging, Meningioma, Glioma, Pituitary Adenoma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Universitaire Ziekenhuizen KU Leuven
Location: Belgium
Summary
The goal of this multicenter prospective longitudinal study is to study the long-term impact of multimodal treatment (chemotherapy, radiotherapy and surgery) in adult brain and base of skull tumors on neurocognitive functioning.All included patients will complete a self-report inventory (subjective cognitive functioning, QoL, confounders), a cognitive test battery, an advanced MR at multiple timepoints.
Moreover, toxicity will be scored according to the CTCAEv5.0 in these patients over time.
Eligibility Criteria
Inclusion Criteria:Adult patients (≥ 18 years at the time of diagnosis) with a primary brain or base of skull tumour, who are amenable for conventionally fractionated radiotherapy (photon or proton irradiation)Exclusion Criteria:Patients with tumours with poor prognostic characteristics (e.g.
IDH1/2 wild type glioma, grade III meningioma, H3K27M midline glioma)Patients with tumours requiring craniospinal irradiation (CSI)/whole ventricular irradiation (WVI)Hypofractionated/stereotactic radiation (fraction sizes > 2 Gy per fraction)Inability to perform the cognitive tests or self-report inventories because of motor/sensory deficits or insufficient Dutch language proficiencyMental retardation documented before diagnosisPre-diagnosis/pre-existing psychiatric diagnosis resulting in cognitive deficits like psychoses, neurodevelopmental disorders (autism/learning disorders)Relapse priory treated by chemo and/or radiation therapyGenetic syndrome (e.g. Down)Unable to perform MR imaging (claustrophobia, metallic implants like pacemaker/ICD/neurostimulator)
Source: ClinicalTrials.gov (NCT05727605). StuddyBuddy aggregates publicly available trial information.