CognitionNARCiSNCT05727605
Neurocognition After Radiotherapy in CNS- and Skull-base Tumors
A study testing Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test, MRI and Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI in people with Cognition and Brain Tumor, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognition, Brain Tumor, Magnetic Resonance Imaging
- What is being tested?
- Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test, MRI and Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesBelgium
- Study dates
- 8 Feb 2023to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
University Hospitals Ghent
Ghent
Tom Boterberg, MD PhD
- Recruiting
UZ Leuven
Leuven
Maarten Lambrecht, MD PhD
- Recruiting
Gasthuis Zusters Antwerpen
Wilrijk
Katrien Erven, MD PhD
About this study
Official title: Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
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.
Read the 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)
- Conditions
- Cognition, Brain Tumor, Magnetic Resonance Imaging, Meningioma, Glioma, Pituitary Adenoma
- Being tested
- Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test, MRI, Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI, Toxicity scoring
- Medical subject headings
- Brain Neoplasms, Meningioma, Glioma, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word TestBehavioural
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
MRIDiagnostic 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, PSQIBehavioural
Time points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy
Toxicity scoringOther
During and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0.
| Study group | Role | What they receive |
|---|---|---|
| Primary brain and skull-base tumors | Other | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 4 years
Secondary outcomes (2)
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
Measured: 4 years
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start8 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Gasthuis Zusters Antwerpen
- Responsible party
- Sponsor
- Investigators
- Maarten Lambrecht, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727605
- Sponsor's protocol ID
- S65664
- Acronym
- NARCiS
- Status last verified
- Apr 2024
- First submitted
- 13 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors
- ClinicalTrials.gov ID
- NCT05727605
- Acronym / sponsor ID
- NARCiS / S65664
- Conditions
- Cognition, Brain Tumor, Magnetic Resonance Imaging, Meningioma, Glioma, Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Gasthuis Zusters Antwerpen
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary brain and skull-base tumors | Other | 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 scoringPrimary 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (13 listed)
- Patients with tumours with poor prognostic characteristics:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word TestPrimary 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 | Behavioural | Primary brain and skull-base tumors |
| MRIAdvanced 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 | Diagnostic test | Primary brain and skull-base tumors |
| Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQITime points: baseline, 12 months post-radiotherapy and 24 months post-radiotherapy | Behavioural | Primary brain and skull-base tumors |
| Toxicity scoringDuring and after radiotherapy and at at the end of the study, adverse events will be monitored using CTCAEv5.0. | Other | Primary brain and skull-base tumors |
Primary outcome
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
Development of a Normal Tissue Complication Probability model (NTCP-model) for each cognitive domain (memory, executive functioning, attention and language)
Time frame: 4 years
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
2 secondary outcomes
Early (3 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)
Time frame: 4 years
Late (12 months post-radiotherapy) changes identified on structural and functional MR imaging (graph measures)
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maarten Lambrecht, MD PhD principal investigator
UZ Leuven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive tests: WAIS digit span, HVLT-R, COWAT, MOCA, WAIS digit symbol substitution, TMT A&B, Stroop Color Word Test, MRI and Questionnaires: EORTC QLQ C30 & BN20, STAI, CFQ, BDI-II, BRIEF-A, FACIT-F, PSQI in people with Cognition and Brain Tumor, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurien De Roeck, MD (016 34 76 00, Laurien.deroeck@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.