Trial Title:
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
NCT ID:
NCT05727605
Condition:
Cognition
Brain Tumor
Magnetic Resonance Imaging
Meningioma
Glioma
Pituitary Adenoma
Conditions: Official terms:
Adenoma
Meningioma
Pituitary Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test
Description:
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
Arm group label:
Primary brain and skull-base tumors
Intervention type:
Diagnostic Test
Intervention name:
MRI
Description:
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
Arm group label:
Primary brain and skull-base tumors
Intervention type:
Behavioral
Intervention name:
Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI
Description:
Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
Arm group label:
Primary brain and skull-base tumors
Intervention type:
Other
Intervention name:
Toxicity scoring
Description:
During and after radiotherapy and at at the end of the study, adverse events will be
monitored using CTCAEv5.0.
Arm group label:
Primary brain and skull-base tumors
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.
Detailed 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)
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Ghent
Address:
City:
Gent
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Tom Boterberg, MD PhD
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Maarten Lambrecht, MD PhD
Facility:
Name:
Gasthuis Zusters Antwerpen
Address:
City:
Wilrijk
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Katrien Erven, MD PhD
Start date:
February 8, 2023
Completion date:
February 1, 2027
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Hospital, Ghent
Agency class:
Other
Collaborator:
Agency:
Gasthuis Zusters Antwerpen
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05727605
