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Clinical Trials/NCT06036706
NCT06036706
Recruiting
Not Applicable

Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study

Centre Francois Baclesse3 sites in 1 country108 target enrollmentSeptember 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meningioma
Sponsor
Centre Francois Baclesse
Enrollment
108
Locations
3
Primary Endpoint
Occurrence of cognitive impairment (a total of ≥ 5 impaired z-scores)
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts.

Registry
clinicaltrials.gov
Start Date
September 13, 2023
End Date
June 1, 2039
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Benign meningioma (grade I), or atypical meningioma (grade II)
  • Histologic proven of benign meningioma, atypical meningioma or unequivocal radiological diagnosis of skull base meningioma if biopsy is recused.
  • Indication of irradiation validated by a multidisciplinary meeting
  • Age \>20 years and \<65 years
  • Expected overall survival \>10 years
  • Adjuvant or exclusive irradiation is allowed.
  • Signed informed consent form
  • WHO Performance status equal to 0 or 1
  • Patient affiliated to the French social health insurance
  • Patient whose neuropsychological abilities allow to follow the requirements of the protocol

Exclusion Criteria

  • Patient with mutation in a known predisposition gene (NF-2, SMARCE-1).
  • Cerebrovascular pathology, presence of other tumors of the nervous system, congenital malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic psychosis (other than dementia), or schizophrenia.
  • Other localization than skull base meningioma
  • Histology/radiological features rather different than grade I-II meningioma
  • Histologic proven grade III meningioma
  • Uncontrolled epilepsy
  • Contraindication to MRI
  • Patient with a history of brain irradiation.
  • Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)
  • Pregnant/breastfeeding woman

Outcomes

Primary Outcomes

Occurrence of cognitive impairment (a total of ≥ 5 impaired z-scores)

Time Frame: 10 years

Occurrence of cognitive impairment in comparison with baseline evaluation (before brain irradiation), evaluated with z-scores

Study Sites (3)

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