To investigate the dose-response relation between cognitive decline and radiotherapy dose for patients with a benign meningioma WHO I.
ID
Source
Brief title
Condition
- Nervous system neoplasms benign
- Nervous system neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between the delta cognitive failure score (baseline vs 2 years) and
radiotherapy dose in cognition related brain regions (supratentorial brain,
hippocampus left/right and anterior/posterior, cerebellum anterior/posterior).
Secondary outcome
- Correlation between baseline imaging (advanced MRI sequence) and patient
specific parameters (e.g. baseline cognitive status, age, Karnofsky index
(KPS), co-morbidity, alcohol consumption, smoking, medication)
- RT-induced cognitive decline measured with extensive cognitive testing;
specifically looking at: Hopkins verbal learning (HVLT), Trail making test A
& B, COWA, Digitspan, LDST, Stroop, Fluency, Dutch wordlist/NLV (IQ-score)
- Correlation of advanced MRI and treatment/dose parameters to PROMS; EQ/5D,
QLQ/C30, QLQ/BN20, Cognitive Failure questionnaire (CFQ) , Multidimentional
Fatigue Index (MVI/20)
- Identification of radiation susceptibility of individual anatomical and
functional central nervous system (CNS) organs (e.g. (hippocampi, frontal lobe,
cerebellum, brain) for radiation damage;
- Sensitivity of additional extensive neurocognitive tests.
- Correlation of advanced MRI and treatment/dose parameters and radiotherapy
modality (photon vs proton)
Background summary
Meningioma are slow growing and frequently occurring intracranial tumors,
responsible for 33% of all asymptomatic intracranial tumors and 13-26% of all
symptomatic primary brain tumors1,2. The 10-year survival rate is 72%. 3 A
variety of treatment options is available for symptomatic meningioma including
surgical removal with or without radiotherapy or radiotherapy alone. These
therapies can have negative impact on cerebral functioning.
After high dose radiotherapy for primary or metastatic brain tumors 50-90% of >
6 months* survivors develop irreversible disabling cognitive decline leading to
premature loss of independence, reduced Quality of Life (QOL) as well as
significant economic burden both at the individual as societal level6.
Especially for patients with a good prognosis like benign meningioma,
maintaining neurocognitive function is crucial. Understanding the mechanisms
underlying radiation induced cognitive decline is complex and which brain areas
to spare are an important subject of research9,10.
Evaluation methods to assess cognitive function and predict cognitive decline
are urgently needed, this will allow the development of optimized treatment
strategies with the aim to preserve or even improve cognitive function in
meningioma patients. Improvements in the field of neuroimaging techniques (i.e.
advanced MRI techniques) have the possibility to identify areas susceptible to
cognitive impairment. This allows in the future a more personalized radiation
treatment by identifying patients at risk, by optimizing the radiotherapy dose
to specific brain regions, that could eventually reduce or prevent, cognitive
decline. Improvements in the field of radiotherapy for example by higher
precision treatment such proton therapy have potential in obtaining these more
individualized strategies
Study objective
To investigate the dose-response relation between cognitive decline and
radiotherapy dose for patients with a benign meningioma WHO I.
Study design
The study is designed as a prospective observational cohort study: patients
with meningioma WHO I tumours treated with radiotherapy will be included,
undergoing extensive cognitive testing combined with advanced brain MRI scans
just before, 3 and 24 months after radiotherapy.
Study burden and risks
The study is non-interventional, we do not expect any risks or benefits for the
patients. The burden related to the completion of additional questionnaires,
neuro-cognitive testing and advanced MRI acquisition is considered low. There
is no individual patient benefit, nevertheless the study will provide new
insights and knowledge to improve the radiation treatment of similar patients
in the future.
Dr. Tanslaan 12
Maastricht 6229ET
NL
Dr. Tanslaan 12
Maastricht 6229ET
NL
Listed location countries
Age
Inclusion criteria
- Meningioma WHO I, grading based on pathology or radiological features
- Age >= 18 years.
- Karnofsky Performance Score 70 or above.
- Ability to comply with the protocol, including neuropsychological testing and
imaging.
- Ability to understand the requirements of the study and to give written
informed consent, as determined by the treating physician.
- Written informed consent.
Exclusion criteria
- Resection meningioma < 3mnd
- Age < 18 years
- Pregnancy
- Any prior cranial radiotherapy
- Any prior chemotherapy in the last 5 years
- Contra-indication for MR imaging (i.e. metal implants, claustrophobia)
- Any other serious medical condition that could interfere with follow-up.
- Severe aphasia or language barrier interfering with assessing endpoints (i.e.
completion of questionnaires or neurocognitive performance)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04638478 |
| CCMO | NL75632.068.20 |