Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radioth
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 rep
| Condition(s) | Cavernous Sinus Meningioma, Proton-therapy, Photon Radiotherapy, Cognitive Impairment |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 kno |
| Who can participate | 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 ≤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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Centre Francois Baclesse |
| Locations | Caen, France; Clamart, France; Grenoble, France; Le Havre, France; Lyon, France; Lyon, France (+7 more sites) |
| Start date | 2024-02-26 |
| NCT ID | NCT05895344 |
| Official listing | https://clinicaltrials.gov/study/NCT05895344 |