NCT06831773

Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma

Phase II Clinical Study of Carbon Ion Combined with Photon Radiotherapy for High-grade Glioma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Gansu Wuwei Tumor Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective is to use the advantages of heavy ion physical dosimetry and biology to improve the tumor control rate and long-term survival rate of high-grade glioma, reduce the occurrence of brain tissue radiation damage caused by increasing prescription dose, and provide new treatment suggestions for glioma radiotherapy.

Detailed description

The investigators tend to make reference to the prescribed dose and segmentation method in the phase I/II clinical study program completed by Mizoe et al., NIRS. It is estimated that the 1-year OS rate of high-grade glioma treated with photon (50Gy divided into 25 times) followed by carbon ion push (24.8GyE divided into 8 times) can reach 87.8%, and the target value is set at 61.1%. A single-center, single-arm, prospective Phase II clinical trial was conducted to evaluate the safety and efficacy of this regimen. The primary end points were treatment-related toxicity, dose-restricted toxicity, and progression-free survival, while the secondary end points were survival and objective response rate. A safe and effective segmentation dose for high-grade glioma suitable for the investigators' facility and RBE model was obtained. Using the physical dosimetry and biological advantages of heavy ions, the investigators can improve the tumor control rate and reduce the occurrence of radiation damage in peripheral brain tissue caused by increasing prescription dose, and provide new treatment suggestions for glioma radiotherapy.

Conditions

• Carbon Ion Radiotheray
• High-grade Glioma
• Heavy Ion Radiotherapy

Interventions

Type	Name	Description
RADIATION	Carbon ion combined with photon radiotherapy	PTV1 was first treated with photon radiotherapy (started within 30 days after surgery), with a total dose of 50Gy, 25 times; After photon radiotherapy, PTV2 carbon ion radiotherapy was started, the total dose was 24.8Gy(RBE), 8 times. 3.1Gy(RBE)/fx; 1fx/ day, 5 days/week.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-02-18
• Last updated: 2025-02-18

Locations

1 site across 1 country: China