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

What this Trial Is About

Researchers are studying the long-term cognitive and functional effects of two types of radiotherapy—proton therapy and conventional photon radiotherapy—in adults with cavernous sinus meningiomas. These tumors are located near critical structures such as the optic nerve and hippocampi, making radiation dose to these areas important due to potential late side effects like pituitary problems, nerve damage, and cognitive impairment. There is currently no prospective study comparing how these modern radiation methods affect brain function over time in these patients. Participants will receive either proton pencil-beam-scanning irradiation or intensity-modulated photon radiotherapy, both given in 28 fractions totaling 50.4 Gy. The study is randomized and open-label, comparing these two radiation approaches in patients aged 18 to 70 with specific types of meningioma. Treatment may be adjuvant or exclusive, and fractionation is standard. The trial is designed to assess if proton therapy's tissue-sparing benefits translate to reduced long-term toxicity. During the study, participants will undergo individual neurocognitive testing to monitor functional changes over five years. Researchers will also evaluate safety and long-term effects related to cognition and function. The total follow-up period allows careful observation of potential neurocognitive deterioration. Participants will provide informed consent and receive care according to protocol, with assessments including neuropsychological abilities and performance status to support study requirements.

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