Impact of Radiotherapy on Neurocognition in Brain Tumor Patients
Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
This study is testing how radiotherapy affects thinking and memory in adults with brain tumors over time to see if certain treatments lead to cognitive decline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 3 sites (Ghent and 2 other locations) |
| Trial ID | NCT05727605 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with primary brain or skull base tumors suitable for conventional radiotherapy.
Not a fit: Patients with poor prognostic tumors or those requiring craniospinal irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of neurocognitive decline in patients undergoing treatment for brain tumors.
How similar studies have performed: Other studies have explored neurocognitive outcomes after radiotherapy, but this approach of combining advanced imaging with detailed cognitive assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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: * 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 this trial is running
Ghent and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.