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

Launched by CENTRE FRANCOIS BACLESSE · Sep 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different types of radiation treatments on patients with benign (grade I) or atypical (grade II) skull base meningiomas, which are generally non-cancerous tumors in the brain. The researchers want to understand how these treatments—intensity-modulated radiotherapy, stereotactic radiotherapy, and proton therapy—affect patients over time, particularly regarding their brain function and quality of life. Participants will undergo yearly brain scans and assessments to monitor any changes in their brain structure and cognitive abilities, such as memory and emotional well-being.

To be eligible for this study, patients must be between 21 and 65 years old, have a confirmed diagnosis of grade I or II meningioma, and be in good overall health. They should not have a history of certain neurological conditions or other significant health issues. Participants can expect to contribute valuable information that could help improve radiation treatment techniques in the future and may receive support for any challenges they face as a result of their treatment. Additionally, a group of healthy individuals will also be involved to help researchers better understand cognitive changes in patients receiving radiation therapy.

Gender

ALL

Eligibility criteria

• 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