Trial Title:
Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma: An Open-label Randomized 1:1 Phase III Study
NCT ID:
NCT05895344
Condition:
Cavernous Sinus Meningioma
Proton-therapy
Photon Radiotherapy
Cognitive Impairment
Conditions: Official terms:
Meningioma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicenter prospective comparative phase 3 randomized 1:1 trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton-therapy
Description:
Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)
Arm group label:
proton-therapy
Intervention type:
Radiation
Intervention name:
Photon radiotherapy
Description:
Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28
fractions)
Arm group label:
photon radiotherapy
Summary:
Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and
hippocampi.
The doses delivered to these structures are crucial and radiotherapy of cavernous sinus
meningiomas exposes patients to late secondary effects (pituitary deficit, nerve palsy,
cognitive impairment...). In 2012, Gondi reported that a dose given to 40% of the
bilateral hippocampi greater than 7.3 Gy is associated with long-term impairment in
list-learning delayed recall after FSRT for benign or low-grade adult brain tumors.
There is no published or recruiting prospective study evaluating the impact of
proton-therapy or conventional irradiation on neurocognitive function for meningioma
patients. Notably, long-term cognitive or ocular impact of these modern irradiation
schemes remains poorly known. Yet, these patients had a long life-expectancy, and are at
risk of developing long-term sequelae. Thus, according to its ballistic advantage, an
improvement of patient functional outcomes and a reduction of neurocognitive long-term
toxicity are expected if tissue sparing proton-therapy is used.
In this context, a randomized prospective study, evaluating long-term toxicity of these
two irradiation modalities (Proton Therapy (PRT) and photon radiotherapy (XRT)) seems
crucial to further assess proton-therapy indication for these patients.
Although literature reports excellent outcomes for intracranial meningioma patients
treated by proton-therapy, none of the eight retrospective studies found in the
literature used an accurate and full evaluation of long-term toxicity
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Cavernous sinus meningioma for which clinical target volume is larger than 3
centimeters
- Anterior skull base meningioma, invading by contiguity the cavernous sinus can be
included
- Histologic proven Grade I meningioma
- Meningioma for which biopsy is not safely achievable and for which growing and
imaging criteria are in favour of grade I meningioma can be included
- Age >18 years and <60 years
- Indication of irradiation validated by a pluridisciplinary meeting
- Adjuvant or exclusive irradiation is allowed.
- Use of conventional fractionation: 1.8Gy (RBE)/fraction
- Signed informed consent form
- WHO Performance status equal to 0 or 1
- Patient affiliated to the French social health insurance
- MoCA score ≥ cut-off of GRECOGVASC normative data (Roussel, 2016, cf annexe 1)
- 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 and other dementias, organic psychosis (other than dementia), schizophrenia,
and neurodegenerative disease
- Radiosurgery, hypofractionated regimen
- Other localization than cavernous sinus
- Histologic proven Grade II or III meningioma
- Patient with unadjusted 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 for less than 30 days
- Patient deprived of freedom or under guardianship
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre François Baclesse
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Recruiting
Contact:
Last name:
Paul LESUEUR, MD
Email:
p.lesueur@baclesse.unicancer.fr
Investigator:
Last name:
Paul LESUEUR, MD
Email:
Principal Investigator
Facility:
Name:
Hopital d'Instruction des Armées PERCY
Address:
City:
Clamart
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Damien RICARD, PhD
Investigator:
Last name:
Damien RICARD, PhD
Email:
Principal Investigator
Facility:
Name:
CHU Grenoble-Alpes
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alexandre, MD
Investigator:
Last name:
Alexandre LEBOUCHER, MD
Email:
Principal Investigator
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre-Yves BONDIAU, PhD
Investigator:
Last name:
Pierre-Yves BONDIAU, PhD
Email:
Principal Investigator
Facility:
Name:
Hôpital Pitié Salpétrière
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Julian JACOB, MD
Investigator:
Last name:
Julian JACOB, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Emmanuel JOUGLAR, MD
Investigator:
Last name:
Emmanuel JOUGLAR, MD
Email:
Principal Investigator
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maxime LOO, MD
Investigator:
Last name:
Maxime LOO, MD
Email:
Principal Investigator
Facility:
Name:
Centre Paul Strauss
Address:
City:
Strasbourg
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Georges NOEL, PhD
Investigator:
Last name:
Georges NOEL, PhD
Email:
Principal Investigator
Facility:
Name:
IUCT
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Justine ATTAL, MD
Investigator:
Last name:
Justine ATTAL, MD
Email:
Principal Investigator
Start date:
February 26, 2024
Completion date:
August 2032
Lead sponsor:
Agency:
Centre Francois Baclesse
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Source:
Centre Francois Baclesse
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05895344
