Phase II Study of Combined Carbon Ion and Photon Radiotherapy for Treating High-grade Glioma

What this Trial Is About

Researchers are investigating carbon ion combined with photon radiotherapy as a treatment for high-grade glioma, a type of brain tumor. This study aims to improve tumor control and long-term survival while reducing brain tissue damage caused by radiation. The trial builds on earlier clinical programs and seeks to find safe and effective dosing for this therapy. Participants first receive photon radiotherapy shortly after surgery, with a total dose of 50 Gy divided into 25 sessions. After completing photon treatment, they receive carbon ion radiotherapy targeting the tumor area with a total dose of 24.8 Gy RBE over 8 sessions, delivered once daily, five days a week. This phase II clinical trial is single-center, single-arm, and prospective, focusing on the safety and efficacy of this combined treatment. Throughout the study, participants undergo regular MRI and enhanced CT scans to monitor tumor response and brain tissue health. Researchers assess treatment-related toxicity, progression-free survival over two years, overall survival, objective remission, and disease control. The study includes evaluations of organ function and physical condition and lasts for at least two years of follow-up to measure outcomes and safety.

Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma