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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05895344

Comparing Long-Term Brain Function After Proton Therapy or Modern Radiotherapy for Cavernous Sinus Meningioma in Adults Aged 18 to 70

Led by Centre Francois Baclesse · Updated on 2025-09-29

160

Participants Needed

13

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the long-term cognitive and functional effects of two types of radiotherapyproton therapy and conventional photon radiotherapyin 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 therapys 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.

CONDITIONS

Brief Title

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

Research Team

J

Jeanne RIVERAIN, MD

J

Jean-Michel GRELLARD

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