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COG-PROTON-01
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
- Open at Paris since : 05/03/2025
- Open at Saint-Cloud since : 01/10/2023
- Target : Adult
- Phase : Phase III
Trial description
To compare the long-term cognitive and/or functional deterioration (visual, auditory, neurological, and/or endocrinological) among patients with cavernous sinus meningioma treated with fractionated proton therapy (PRT) or photon radiotherapy (XRT), five years after irradiation.;At the patient level:;Evaluate the time from treatment to cognitive or functional deterioration.;Analyze the impact of irradiation on:;Vision (optic nerve damage).;Hearing (auditory nerve damage).;Endocrine function (pituitary axis impairment).;Cranial nerves.;Assess the evolution of health-related quality of life after irradiation.;Monitor professional reintegration for working-age patients.;Measure medical care consumption and healthcare costs over five years.;📌 At the radiotherapy level:;Compare the dosimetric impact on organs at risk between proton and photon therapy.;Evaluate the correlation between late radiation dose and cognitive deterioration.;📌 At the brain MRI level:;Analyze alterations in cortical structures, hippocampi, sub-ventricular areas, and white matter after irradiation.;Correlate MRI changes with cognitive impairment.
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