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
Recruiting
N/A
Interventional Study
Cavernous Sinus Meningioma
Proton-therapy
Photon Radiotherapy
Cognitive Impairment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- Centre Francois Baclesse · Other
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About This Trial
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 …
Trial Locations
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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 a…
Contacts