Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
NARCiS
1 other identifier
interventional
120
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2023
CompletedStudy Start
First participant enrolled
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedMay 8, 2024
April 1, 2024
3 years
January 13, 2023
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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)
2 years
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
4 years
Secondary Outcomes (2)
Early (3 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)
4 years
Late (12 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)
4 years
Study Arms (1)
Primary brain and skull-base tumors
OTHERPrimary 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
Interventions
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
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
Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- University Hospital, Ghentcollaborator
- Gasthuis Zusters Antwerpencollaborator
Study Sites (3)
University Hospitals Ghent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Gasthuis Zusters Antwerpen
Wilrijk, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Lambrecht, MD PhD
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2023
First Posted
February 14, 2023
Study Start
February 8, 2023
Primary Completion
February 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
May 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share