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
Key facts
- Who runs it
- Centre Francois Baclesse
- Where
- France13 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 160 people, planned
- Started
- 26 Feb 2024
- Expected to end
- Aug 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Proton-therapy
- Photon radiotherapy
- Record updated
- 29 September 2025
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patient with unadjusted antiepileptic drug
- 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
- Patient with a history of brain irradiation
- Patient with a history of cancer in the last five years (excluding skin baso-cellular carcinoma)
- Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study
- Patient with mutation in a known predisposition gene (NF-2, SMARCE-1…)
- Radiosurgery, hypofractionated regimen
- Other localization than cavernous sinus
- Histologic proven Grade II or III meningioma
- Contraindication to MRI
- Pregnant/breastfeeding woman
- Participation in a therapeutic trial for less than 30 days
- Patient deprived of freedom or under guardianship
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Cavernous sinus meningiomas are close to optic nerve, pituitary gland, cranial nerve, and hippocampi.
Read full original descriptionShow less
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
The 2 groups in the trial
- proton-therapyTreatment being tested
Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)
- photon radiotherapyExisting treatment, for comparison
Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma
- Fit questions
- Built from NCT05895344, who can take part
- Record updated
- 29 September 2025