Status:
RECRUITING
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
Région Normandie
Conditions:
Meningioma
Radiation Toxicity
Eligibility:
All Genders
20-65 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- Patients:
- 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
- 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
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2039
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06036706
Start Date
September 13 2023
End Date
June 1 2039
Last Update
June 24 2025
Active Locations (3)
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1
centre François Baclesse
Caen, France, 14000
2
Centre Guillaume le Conquérant
Le Havre, France
3
Centre Henri Becquerel
Rouen, France