Impact of different radiation therapies on cognitive function in meningioma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates the neurocognitive effects of various radiation therapies, including intensity-modulated radiotherapy, stereotactic radiotherapy, and proton therapy, on patients with grade I-II skull base meningiomas. Patients will be monitored through yearly multi-parametric brain MRIs to assess changes in brain morphology and cognitive performance, alongside evaluating health-related quality of life and psychological factors. The study aims to correlate dosimetric data with neurocognitive outcomes to better understand the long-term effects of these radiation modalities.

Why it matters

Who can join: the full rules

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

Where it's running

• centre François Baclesse
  Caen, France Recruiting
• Centre Guillaume le Conquérant
  Le Havre, France Not yet recruiting
• Centre Henri Becquerel
  Rouen, France Not yet recruiting

Study contacts

• Study coordinator: Jeanne RIVERAIN, MD
• Email: j.riverain@baclesse.unicancer.fr
• Phone: +33 2 31 45 50 50

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.