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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

- History of epilepsy with antiepileptic drug.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06036706
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Francois Baclesse
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Meningioma, Radiation Toxicity

Arms & Interventions

Arms

Other: Cohort "IMRT":

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

Other: Cohort "SRT"

Patients receiving hypo-fractionated stereotactic brain irradiation

Other: Cohort "PRT"

Patients receiving normo-fractionated proton therapy brain irradiation

Other: Control cohort

Participants without any meningioma, cancer history or neurological comorbidities

Interventions

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

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

Radiation: - Hypo-fractionated stereotactic brain irradiation

Patients receiving hypo-fractionated stereotactic brain irradiation

Radiation: - Normo-fractionated proton therapy brain irradiation

Patients receiving normo-fractionated proton therapy brain irradiation

Other: - Cognitive assessment by a trained neuropsychologis

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.