Impact of Radiotherapy on Neurocognition in Brain Tumor Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective longitudinal study aims to assess the long-term effects of multimodal treatment, including chemotherapy, radiotherapy, and surgery, on neurocognitive functioning in adults with brain and skull base tumors. Participants will undergo a series of cognitive tests, self-report inventories, and advanced MRI scans at multiple time points, both before and after radiotherapy. The study seeks to develop a model predicting neurocognitive decline based on radiation dose and brain structure susceptibility, while also evaluating the prevalence and severity of cognitive decline across various domains.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Hospitals Ghent
  Ghent, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Gasthuis Zusters Antwerpen
  Wilrijk, Belgium Recruiting

Study contacts

• Principal investigator: Maarten Lambrecht, MD PhD — UZ Leuven
• Study coordinator: Laurien De Roeck, MD
• Email: Laurien.deroeck@uzleuven.be
• Phone: 016 34 76 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.