Evaluating Preoperative Proton Stereotactic Radiotherapy and Standard Treatment in Adults with High-grade Brain Gliomas

What this Trial Is About

Researchers are studying if preoperative proton therapy PPT is tolerable and safe for adults with high-grade brain gliomas, including glioblastomas. These aggressive brain tumors have poor survival rates and limited treatment advances. The trial aims to determine the highest safe dose of PPT and its effects on surgery, clinical outcomes, and safety. Participants receive preoperative proton stereotactic radiotherapy targeting the tumor with increasing dose levels in small groups of patients. This is followed by surgical removal of the tumors contrast-enhancing part using advanced imaging and monitoring techniques. After surgery, MRI scans assess tumor removal, and a follow-up evaluation occurs 3-4 weeks later. Then, standard chemoradiotherapy with proton beams and temozolomide chemotherapy begins 4-6 weeks after surgery, followed by maintenance chemotherapy for up to 12 cycles or until disease progression. During the study, participants undergo clinical, radiological, and morphological assessments to evaluate treatment effects and safety. Follow-up exams happen monthly after chemoradiotherapy and then quarterly during the first year. The main outcome measured is radiation-induced toxicity over 12 months, along with clinical effects, maximal irradiation dose, and postoperative safety. The total participation period extends up to several years, including standard treatment and monitoring.

Preoperative Proton Irradiation for High-grade Brain Gliomas.