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New treatment option for Cavernous Sinus Meningioma
Official 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
ClinicalTrials.gov ID: NCT05895344
What this study is testing
- What it's testing
- 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…).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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 ≤70 years
You likely can't join 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...
- Radiosurgery, hypofractionated regimen
- Other localization than cavernous sinus
- Histologic proven Grade II or III meningioma
- Patient with unadjusted antiepileptic drug
See the full eligibility 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 ≤70 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
- Clamart, France
- Grenoble, France
- Le Havre, France
- Lyon, France
- Nice, France
- Paris, France
- Saint-Cloud, France
- Strasbourg, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France; Clamart, France; Grenoble, France; Le Havre, France; Lyon, France; Nice, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.