Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorCentre Francois Baclesse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning

    Radiation

    Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)

  • Hypo-fractionated stereotactic brain irradiation

    Radiation

    Patients receiving hypo-fractionated stereotactic brain irradiation

  • Normo-fractionated proton therapy brain irradiation

    Radiation

    Patients receiving normo-fractionated proton therapy brain irradiation

  • Cognitive assessment by a trained neuropsychologis

    Other intervention

    Participants without any meningioma, cancer history or neurological comorbidities will undergo cognitive assessment by a trained neuropsychologist, similarly as for patients

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: Cohort "IMRT":Other 1 intervention
Group B: Cohort "SRT"Other 1 intervention
Group C: Cohort "PRT"Other 1 intervention
Group D: Control cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Centre Francois Baclesse

Lead sponsor

Région Normandie

Collaborator