Impact of different radiation therapies on cognitive function in meningioma patients
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study
This study is testing how different types of radiation therapy affect thinking and memory in patients with certain brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Caen and 2 other locations) |
| Trial ID | NCT06036706 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 65 with a confirmed diagnosis of benign or atypical meningioma who are eligible for radiation therapy.
Not a fit: Patients with genetic predispositions to meningiomas or significant neurological comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that minimize cognitive damage in patients undergoing radiation therapy for meningiomas.
How similar studies have performed: While there have been studies on radiation effects in brain tumors, this specific comparison of different radiation modalities in meningioma patients is relatively novel.
Eligibility criteria
Show full 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 * 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 this trial is running
Caen and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.