Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
Universitaire Ziekenhuizen KU Leuven
120 participants
Feb 8, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria13
- 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)
Interventions
Primary brain tumour patients will be evaluated longitudinally at the following timepoints: baseline (minimal 4 weeks after surgery, before radiotherapy), three months after end of radiotherapy, 1 year after end of radiotherapy and 2 years after end of radiotherapy. At each visit, neurocognitive testing, a self-report inventory and/or advanced MR imaging will take place. Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
Advanced MRI: all participants will be scanned on a 3T Siemens of Philips MR scanner (multicenter protocol): MPRAGE, FLAIR, T2, DWI, rsfMRI, SWI \& ASL Time points: baseline, 3 months post-radiotherapy and 12 months post-radiotherapy
Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.
Locations(3)
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NCT05727605