Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma: An Open-label Randomized 1:1 Phase III Study

Inclusion Criteria:

• Cavernous sinus meningioma for which clinical target volume is larger than 3centimeters

• Anterior skull base meningioma, invading by contiguity the cavernous sinus can beincluded

• Histologic proven Grade I meningioma

• Meningioma for which biopsy is not safely achievable and for which growing andimaging criteria are in favour of grade I meningioma can be included

• Age >18 years and ≤70 years

• Indication of irradiation validated by a pluridisciplinary meeting

• Adjuvant or exclusive irradiation is allowed.

• Use of conventional fractionation: 1.8Gy (RBE)/fraction

• Signed informed consent form

• WHO Performance status equal to 0 or 1

• Patient affiliated to the French social health insurance

• MoCA score ≥ cut-off of GRECOGVASC normative data (Roussel, 2016, cf annexe 1)

• Patient whose neuropsychological abilities allow to follow the requirements of theprotocol

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'sdisease and other dementias, organic psychosis (other than dementia), schizophrenia,and neurodegenerative disease

• Radiosurgery, hypofractionated regimen

• Other localization than cavernous sinus

• Histologic proven Grade II or III meningioma

• Patient with unadjusted antiepileptic drug

• Contraindication to MRI

• Patient with a history of brain irradiation

• Patient with a history of cancer in the last five years (excluding skinbaso-cellular carcinoma)

• Pregnant/breastfeeding woman

• Any geographical conditions, social and associated psychopathology that maycompromise the patient's ability to participate in the study

• Participation in a therapeutic trial for less than 30 days

• Patient deprived of freedom or under guardianship