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

Primary Purpose

Meningioma, Radiation Toxicity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningioma

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • centre François BaclesseRecruiting
  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Cohort "IMRT":

Cohort "SRT"

Cohort "PRT"

Control cohort

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
September 13, 2023
Sponsor
Centre Francois Baclesse
Collaborators
Région Normandie
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1. Study Identification

Unique Protocol Identification Number
NCT06036706
Brief Title
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
September 2038 (Anticipated)
Study Completion Date
June 2039 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Région Normandie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma, Radiation Toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort "IMRT":
Arm Type
Other
Arm Description
Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
Arm Title
Cohort "SRT"
Arm Type
Other
Arm Description
Patients receiving hypo-fractionated stereotactic brain irradiation
Arm Title
Cohort "PRT"
Arm Type
Other
Arm Description
Patients receiving normo-fractionated proton therapy brain irradiation
Arm Title
Control cohort
Arm Type
Other
Arm Description
Participants without any meningioma, cancer history or neurological comorbidities
Intervention Type
Radiation
Intervention Name(s)
Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning
Intervention Description
Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
Intervention Type
Radiation
Intervention Name(s)
Hypo-fractionated stereotactic brain irradiation
Intervention Description
Patients receiving hypo-fractionated stereotactic brain irradiation
Intervention Type
Radiation
Intervention Name(s)
Normo-fractionated proton therapy brain irradiation
Intervention Description
Patients receiving normo-fractionated proton therapy brain irradiation
Intervention Type
Other
Intervention Name(s)
Cognitive assessment by a trained neuropsychologis
Intervention Description
Participants without any meningioma, cancer history or neurological comorbidities will undergo cognitive assessment by a trained neuropsychologist, similarly as for patients
Primary Outcome Measure Information:
Title
Occurrence of cognitive impairment (a total of ≥ 5 impaired z-scores)
Description
Occurrence of cognitive impairment in comparison with baseline evaluation (before brain irradiation), evaluated with z-scores
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul LESUEUR, MD
Phone
+33 2 31 45 50 50
Email
p.lesueur@baclesse.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel GRELLARD
Phone
+33 2 31 45 50 50
Email
jm.grellard@baclesse.unicancer.fr
Facility Information:
Facility Name
centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul LESUEUR, MD
First Name & Middle Initial & Last Name & Degree
Paul LESUEUR, MD
First Name & Middle Initial & Last Name & Degree
Dinu STEFAN, MD
First Name & Middle Initial & Last Name & Degree
Julien GEFFRELOT, MD
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien THUREAU, PhD
First Name & Middle Initial & Last Name & Degree
Sébastien THUREAU, PhD
First Name & Middle Initial & Last Name & Degree
Ovidiu VERESEZAN, MD

12. IPD Sharing Statement

Learn more about this trial

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

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