AzTrials
AzTrials

MeningiomaCANCER-COGNCT06036706

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

A study testing Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning, Hypo-fractionated stereotactic brain irradiation and Normo-fractionated proton therapy brain irradiation in people with Meningioma and Radiation Toxicity, run by Centre Francois Baclesse at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Meningioma, Radiation Toxicity
What is being tested?
Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning, Hypo-fractionated stereotactic brain irradiation and Normo-fractionated proton therapy brain irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
3 sitesFrance
Study dates
13 Sep 2023to Jun 2039
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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 join

  • 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
Show all 15Show fewer
  • 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:

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jeanne RIVERAIN, MD contact

+33 2 31 45 50 50

j.riverain@baclesse.unicancer.fr

Jean-Michel GRELLARD contact

+33 2 31 45 50 50

jm.grellard@baclesse.unicancer.fr

France3 sites, 3 recruiting

  • centre François Baclesse

    Caen, 14000

    Jeanne RIVERAIN, MD, j.riverain@baclesse.unicancer.fr

    Paul LESUEUR, MD

    Recruiting

  • Centre Guillaume le Conquérant

    Le Havre

    Paul LESUEUR, MD, +33 (0) 35 13 66 13, p.lesueur@cglc.fr

    Paul LESUEUR, MD

    Not yet recruiting

  • Centre Henri Becquerel

    Rouen

    Sébastien THUREAU, PhD

    Sébastien THUREAU, PhD

    Not yet recruiting

Other trials in France

About this study

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

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.

Being 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
Medical subject headings
Meningioma, Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioningRadiation

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

  • Hypo-fractionated stereotactic brain irradiationRadiation

    Patients receiving hypo-fractionated stereotactic brain irradiation

  • Normo-fractionated proton therapy brain irradiationRadiation

    Patients receiving normo-fractionated proton therapy brain irradiation

  • Cognitive assessment by a trained neuropsychologisOther

    Participants without any meningioma, cancer history or neurological comorbidities will undergo cognitive assessment by a trained neuropsychologist, similarly as for patients

Study groups in NCT06036706
Study groupRoleWhat they receive
Cohort "IMRT":OtherPatients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
Receives: Radiation: Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning
Cohort "SRT"OtherPatients receiving hypo-fractionated stereotactic brain irradiation
Receives: Radiation: Hypo-fractionated stereotactic brain irradiation
Cohort "PRT"OtherPatients receiving normo-fractionated proton therapy brain irradiation
Receives: Radiation: Normo-fractionated proton therapy brain irradiation
Control cohortOtherParticipants without any meningioma, cancer history or neurological comorbidities
Receives: Other: Cognitive assessment by a trained neuropsychologis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start13 Sep 2023
  3. Primary completionSep 2038 (estimated)
  4. Study completionJun 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036706
Sponsor's protocol ID
2022-A02097-36
Acronym
CANCER-COG
Status last verified
Jun 2025
First submitted
31 Aug 2023
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39881369

Questions about this trial

What is this clinical trial studying?

A study testing Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning, Hypo-fractionated stereotactic brain irradiation and Normo-fractionated proton therapy brain irradiation in people with Meningioma and Radiation Toxicity, run by Centre Francois Baclesse at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeanne RIVERAIN, MD (+33 2 31 45 50 50, j.riverain@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of cognitive impairment (a total of ≥ 5 impaired z-scores) (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06036706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in