Study of High Dose Fractionated Stereotactic Radiation Therapy for Treating Brain Metastases Using Modern Equipment

What this Trial Is About

Brain metastasis is a serious condition with limited survival for untreated patients, typically only 1-2 months. Researchers are studying isotoxic high dose fractionated stereotactic radiation therapy iHD-SRT as a local treatment to improve tumor control while protecting brain function. This trial explores optimizing stereotactic radiotherapy SRT dosage based on normal tissue tolerance to enhance treatment effects for brain metastases, addressing the lack of prospective data comparing different SRT dosages and fractionation schemes. Participants will receive iHD-SRT, a precise radiation therapy using high-resolution equipment to deliver individualized doses with biologically effective dose BED10 greater than 50 Gy but less than 100 Gy. This approach aims to maximize tumor control while respecting organ-at-risk limits to reduce brain toxicity. The study is a single-arm, open-label, prospective trial enrolling 35 patients over two years, followed by one year of monitoring. During the study, participants will undergo treatment with iHD-SRT and be closely monitored for treatment completion and side effects, especially radiation-induced brain necrosis within one year. The main outcomes measured are the proportion of patients receiving the targeted radiation dose and the incidence of brain necrosis. Follow-up will assess safety and feasibility, with an expected total involvement of three years from treatment start to final evaluation.

a Feasibility Study of iHD-SRT for BM