Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
CANCER-COG
1 other identifier
interventional
108
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedStudy Start
First participant enrolled
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2039
June 24, 2025
June 1, 2025
15 years
August 31, 2023
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Cohort "IMRT":
OTHERPatients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
Cohort "SRT"
OTHERPatients receiving hypo-fractionated stereotactic brain irradiation
Cohort "PRT"
OTHERPatients receiving normo-fractionated proton therapy brain irradiation
Control cohort
OTHERParticipants without any meningioma, cancer history or neurological comorbidities
Interventions
Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
Patients receiving hypo-fractionated stereotactic brain irradiation
Patients receiving normo-fractionated proton therapy brain irradiation
Participants without any meningioma, cancer history or neurological comorbidities will undergo cognitive assessment by a trained neuropsychologist, similarly as for patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- Région Normandiecollaborator
Study Sites (3)
centre François Baclesse
Caen, 14000, France
Centre Guillaume le Conquérant
Le Havre, France
Centre Henri Becquerel
Rouen, France
Related Publications (1)
Lesueur P, Joly F, Clarisse B, Lequesne J, Stefan D, Balosso J, Lange M, Thureau S, Capel A, Castera M, Legrand B, Goliot N, Grellard JM, Tessonnier T, Castel H, Valable S. Neurocognitive impact of different irradiation modalities for patients with grade I-II skull base meningioma: a prospective multi-arm cohort study (CANCER COG). Radiat Oncol. 2025 Jan 29;20(1):16. doi: 10.1186/s13014-025-02591-1.
PMID: 39881369DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 14, 2023
Study Start
September 13, 2023
Primary Completion (Estimated)
September 1, 2038
Study Completion (Estimated)
June 1, 2039
Last Updated
June 24, 2025
Record last verified: 2025-06