Clinical trial · Interventional
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Cognition | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Magnetic Resonance Imaging | — | UNRESOLVED | — |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
| Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test | Behavioral | — | UNRESOLVED |
| Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI | Behavioral | — | UNRESOLVED |
| Toxicity scoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Primary brain and skull-base tumors
- description
- Primary brain and skull-base tumors who are amenable for radiotherapy (photon or proton therapy) will all be examined with neurocognitive tests, questionnaires and advanced MR imaging
- interventionNames
- Behavioral: Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test
- Diagnostic Test: MRI
- Behavioral: Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI
- Other: Toxicity scoring
Primary outcomes (2)
- measure
- Prevalence of neurocognitive decline (changes in z-scores) compared to baseline at one year post-radiotherapy, for all cognitive domains (memory, executive functioning, attention and language)
- timeFrame
- 2 years
- measure
- Development of a Normal Tissue Complication Probability model (NTCP-model) for each cognitive domain (memory, executive functioning, attention and language)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available