Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Recruiting now · Not applicable
Conditions studied: Cognition, Brain Tumor, Magnetic Resonance Imaging, Meningioma, Glioma, Pituitary Adenoma
In brief
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.
Key facts
- Study ID
- NCT05727605
- Run by
- Universitaire Ziekenhuizen KU Leuven
- People needed
- 120
- Starts
- 2023-02-08
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2024-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- University Hospitals Ghent — Ghent, Belgium (enrolling)
- UZ Leuven — Leuven, Belgium (enrolling)
- Gasthuis Zusters Antwerpen — Wilrijk, Belgium (enrolling)
Full record on ClinicalTrials.gov
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