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

Radiation Toxicity Clinical Trial

— CANCER-COG  

Official title:

Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036706
• Other study ID #: 2022-A02097-36
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: June 2039

Study information

• Verified date: August 2023
• Source: Centre Francois Baclesse
• Contact: Paul LESUEUR, MD
• Phone: +33 2 31 45 50 50
• Email: p.lesueur[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2039
• Est. primary completion date: September 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningioma
• Radiation Toxicity

Intervention

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…)
• Hypo-fractionated stereotactic brain irradiation
Patients receiving hypo-fractionated stereotactic brain irradiation
• 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

Locations

Country	Name	City	State
France	centre François Baclesse	Caen
France	Centre Henri Becquerel	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Région Normandie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of cognitive impairment (a total of = 5 impaired z-scores)	Occurrence of cognitive impairment in comparison with baseline evaluation (before brain irradiation), evaluated with z-scores	10 years