CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 160 target
Drug / intervention
Proton-therapy +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 12
  • Cavernous sinus meningioma with clinical target volume >3cm
  • Anterior skull base meningioma invading cavernous sinus by contiguity
  • Histologically proven Grade I meningioma
  • Biopsy not safely achievable with imaging/growth criteria favoring Grade I
Key exclusion· 14
  • Mutation in known predisposition gene (NF-2, SMARCE-1)
  • Cerebrovascular pathology, other nervous system tumors, CNS congenital malformations
  • Multiple sclerosis, Parkinson's disease, other dementias, organic psychosis, schizophrenia, neurodegenerative disease
  • Radiosurgery or hypofractionated regimen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05895344
NCT05895344N/ARecruitingOn TrackUpdated 9mo ago

Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma

Centre Francois Baclesse·interventional·Posted Jun 8, 2023·Updated Sep 29, 2025

In Brief

A clinical study evaluating Proton-therapy and Photon radiotherapy for Cavernous Sinus Meningioma and 3 related conditions. Currently recruiting, targeting 160 participants across 13 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ARecruiting
202420252026202720282029203020312032
First PostedJun 8, 2023
Enrollment StartFeb 26, 2024
Primary CompletionFeb 1, 2032
Study CompletionAug 1, 2032
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 3.1 years agoPrimary completion in 5.6 years

Interventions

Proton-therapyradiation

Proton pencil-beam-scanning irradiation (50,4 Gy (RBE) in 28 fractions)

Photon radiotherapyradiation

Intensity modulated radiotherapy with or without stereotactic positioning (50,4 Gy in 28 fractions)