Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

Phase

N/A

Condition

Brain Tumor

Memory Loss

Cancer/tumors

Treatment

Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI

MRI

Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test

Clinical Study ID

NCT05727605

S65664

Ages > 18
All Genders

Study 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

Inclusion Criteria:

Adult patients (≥ 18 years at the time of diagnosis) with a primary brain or base ofskull tumour, who are amenable for conventionally fractionated radiotherapy (photon orproton irradiation)

Exclusion

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 ventricularirradiation (WVI)
Hypofractionated/stereotactic radiation (fraction sizes > 2 Gy per fraction)
Inability to perform the cognitive tests or self-report inventories because ofmotor/sensory deficits or insufficient Dutch language proficiency
Mental retardation documented before diagnosis
Pre-diagnosis/pre-existing psychiatric diagnosis resulting in cognitive deficits likepsychoses, 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 likepacemaker/ICD/neurostimulator)

Study Design

Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI

February 08, 2023

February 01, 2027

Study Description

This study will combine MR imaging techniques together with elaborate neuropsychological assessments and RT dosimetry in 120 patients who will be examined baseline (before RT) and followed longitudinally after RT.

The first objective is to build an NTCP model for neurocognitive decline after RT (for each cognitive domain separately), linking dose-volume parameters to structures within the brain susceptible to neurological damage and neurocognitive decline after radiotherapy. These NTCP models can be used to make predictions on neurocognitive decline in future primary brain tumour patients receiving cranial RT.

The second objective is to evaluate dose-dependent neurocognitive decline. In particular, the investigators will assess:

Prevalence and severity of neurocognitive decline after RT for all cognitive domains
Brain structures or functional brain connections important in neurocognitive functioning (based on dedicated MRI).
Dose-dependencies of specific neurocognitive skills after RT in adult brain tumour patients
Correlations between RT dosimetry and early brain changes (MRI)

Connect with a study center

University Hospitals Ghent
Gent,
Belgium
Active - Recruiting
UZ Leuven
Leuven,
Belgium
Active - Recruiting
Gasthuis Zusters Antwerpen
Wilrijk,
Belgium
Active - Recruiting

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