Under construction – not a live service
Sign in
Taking peopleNo phase

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

Key facts

Who runs it
Centre Francois Baclesse
Where
France3 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
108 people, planned
Started
13 Sept 2023
Expected to end
Jun 2039
Type of study
Interventional, 4 groups
Treatments tested
  • Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning
  • Hypo-fractionated stereotactic brain irradiation
  • Normo-fractionated proton therapy brain irradiation
  • Cognitive assessment by a trained neuropsychologis
Record updated
24 June 2025

Who can take part

Age
20 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 39 criteriaShow less

Who can take part

  • 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
  • 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

Who cannot take part

  • Participation in a therapeutic trial evaluating a radiotherapy schedule or a new drug or combination for less than 30 days
  • 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
  • Uncontrolled epilepsy
  • Patient with a history of brain irradiation
  • Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)
  • Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study
  • Hypersensibility to Gadolinium; Participants free of brain disease or cancer history:
  • Patient with mutation in a known predisposition gene (NF-2, SMARCE-1)
  • Other localization than skull base meningioma
  • Histology/radiological features rather different than grade I-II meningioma
  • Histologic proven grade III meningioma
  • Contraindication to MRI
  • Pregnant/breastfeeding woman
  • Patient deprived of freedom or under guardianship

Other criteria

  • Patients:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Cohort "IMRT":Other group

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

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

  • Cohort "SRT"Other group

    Patients receiving hypo-fractionated stereotactic brain irradiation

    Treatment: Hypo-fractionated stereotactic brain irradiation

  • Cohort "PRT"Other group

    Patients receiving normo-fractionated proton therapy brain irradiation

    Treatment: Normo-fractionated proton therapy brain irradiation

  • Control cohortOther group

    Participants without any meningioma, cancer history or neurological comorbidities

    Treatment: Cognitive assessment by a trained neuropsychologis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study
Fit questions
Built from NCT06036706, who can take part
Record updated
24 June 2025