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Neurocognition After Radiotherapy in CNS- and Skull-base Tumors

ConditionsCognitionBrain TumorMagnetic Resonance ImagingMeningiomaGliomaPituitary Adenoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

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

    Behavioral

    Primary brain tumour patients will be evaluated longitudinally at the following timepoints: baseline (minimal 4 weeks after surgery, before radiotherapy), three months after end of radiotherapy, 1 year after end of radiotherapy and 2 years after end of radiotherapy. At each visit, neurocognitive testing, a self-report inventory and/or advanced MR imaging will take place. Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy

  • MRI

    Diagnostic test

    Advanced MRI: all participants will be scanned on a 3T Siemens of Philips MR scanner (multicenter protocol): MPRAGE, FLAIR, T2, DWI, rsfMRI, SWI \& ASL Time points: baseline, 3 months post-radiotherapy and 12 months post-radiotherapy

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

    Behavioral

    Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy

  • Toxicity scoring

    Other intervention

    During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Primary brain and skull-base tumorsOther 4 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
2 years
2

Development of a Normal Tissue Complication Probability model (NTCP-model) for each cognitive domain (memory, executive functioning, attention and language)

Construct NTCP models to predict neurocognitive decline based on RT dosimetric and other explanatory variables (gender, age at diagnosis, comorbidities, level of education, social factors such as social activity and occupation, tumour size and localization, pathological/genetic/molecular characteristics, therapy protocols (surgery, radiotherapy and/or chemotherapy)) in an NTCP model for each cognitive domain

Time frame
4 years

Secondary outcomes

1

Early (3 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)

Changes on advanced MR imaging at 3 months post-RT compared to baseline

Time frame
4 years
2

Late (12 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)

Changes on advanced MR imaging at 12 months post-RT compared to baseline

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

University Hospital, Ghent

Collaborator

Gasthuis Zusters Antwerpen

Collaborator

Source ClinicalTrials.gov
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