Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
Qualifiers
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)
Disqualifiers
Incompletely resected IDH-wild-type glioma
Completely resected IDH-wild-type and MGMT-promotor unmethylated glioma
grade III meningioma
H3K27M+ midline glioma
Trial design
Treatments tested in this trial
- Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test
- MRI
- Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI
- Toxicity scoring
Treatment groups
120 Participants
are divided into 1 treatment groupLocations
3University Hospitals Ghent Ghent Belgium
UZ Leuven Leuven Belgium
Gasthuis Zusters Antwerpen Wilrijk Belgium
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Ghent
Collaborator
Gasthuis Zusters Antwerpen
Collaborator
Source ClinicalTrials.gov