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NCT Number: NCT05727605

Neurocognition After Radiotherapy in CNS- and Skull-base 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.

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Key information

Conditions

Cognition Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glioma Hypothalamic Diseases Hypothalamic Neoplasms Magnetic Resonance Imaging Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pituitary Adenoma Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Ghent, Ghent, Belgium

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

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)

    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

Secondary outcomes

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

    Time frame: 4 years

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

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

    Time frame: 4 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurien De Roeck, MD

CONTACT

[email protected]

016 34 76 00

Maarten Lambrecht, MD PhD

CONTACT

[email protected]

016 34 76 00

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Gasthuis Zusters Antwerpen
  • University Hospital, Ghent

Registry information

Official study title

Neurocognition After Radiotherapy in Adult Brain and Base of Skull Tumors

Acronym: NARCiS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 14, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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