NCT05727605 Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
| NCT ID | NCT05727605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Cognition |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-02-08 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-02-08 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Maarten Lambrecht, MD PhD
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT05727605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05727605 currently recruiting?
Yes, NCT05727605 is actively recruiting participants. Contact the research team at Laurien.deroeck@uzleuven.be for enrollment information.
Where is the NCT05727605 trial being conducted?
This trial is being conducted at Ghent, Belgium, Leuven, Belgium, Wilrijk, Belgium.
Who is sponsoring the NCT05727605 clinical trial?
NCT05727605 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Maarten Lambrecht, MD PhD at UZ Leuven. The trial plans to enroll 120 participants.