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

RecruitingNAAges 20 Years - 65 YearsAllCentre Francois Baclesse
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In plain words

What the trial is, and whether it could suit you

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, dos

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📋 Eligibility rules (as published)
Patients: 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 * Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study * Participation in a therapeutic trial evaluating a radiotherapy schedule or a new drug or combination for less than 30 days * Patient deprived of freedom or under guardianship * Hypersensibility to Gadolinium Participants free of brain disease or cancer history: Inclusion Criteria: * Subject without any history of neurological disease (cerebral stroke, epilepsy, Intra cranial Neurosurgery procedure, meningioma, pituitary adenoma, Parkinson disease,Dementia…) or absence of personality disorders and progressive psychiatric pathology * Age \>20 years and \<65 years * Signed informed consent form * WHO Performance status equal to 0 or 1 * Subject affiliated to the French social health insurance * Subject whose neuropsychological abilities allow to follow the requirements of the protocol * No major cognitive disorder that may compromise the realization of cognitive evaluations, defined as a MoCA score in accordance with the threshold depending on age and educational level according to the GRECOGVASC normative data Non-inclusion criteria * 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 * History of epilepsy with antiepileptic drug * Subject with a history of brain irradiation * Subject with a history of cancer in the last five years (Excluding skin baso-cellular carcinoma) * Pregnant/breastfeeding woman * Any geographical conditions, social and associated psychopathology that may compromise the subject's ability to participate in the study * Participation in a therapeutic trial - Subject deprived of freedom or under guardianship
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What it tests

  • Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning
  • Hypo-fractionated stereotactic brain irradiation
  • Normo-fractionated proton therapy brain irradiation
  • Cognitive assessment by a trained neuropsychologis
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Where

3 sites
centre François Baclesse
Caen, France
Centre Guillaume le Conquérant
Le Havre, France
Centre Henri Becquerel
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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