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Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT05727605 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: * Incompletely resected IDH-wild-type glioma * Completely resected IDH-wild-type and MGMT-promotor unmethylated 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 proficiency * Mental retardation documented before diagnosis * Pre-diagnosis/pre-existing psychiatric diagnosis resulting in cognitive deficits like psychoses, neurodevelopmental disorders (autism/learning disorders) * Relapse previously treated by chemo and/or radiation therapy * Genetic syndrome (e.g. Down) * Unable to perform MR imaging (claustrophobia, metallic implants like pacemaker/ICD/neurostimulator)
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What it tests

  • Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test
  • MRI
  • Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI
  • Toxicity scoring
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Where

3 sites
University Hospitals Ghent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Gasthuis Zusters Antwerpen
Wilrijk, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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