NCT07405047

Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.

Detailed description

This study plans to enroll 48 patients with 1-4 brain metastases with ≤2cm in diameter. All of the patients will receive FSRT with the dose of 30 Gy in 5 fractions. The primary endpoint is local control rate of asymptomatic brain necrosis at 1 year. The secondary endpoints include disease control rate at 2 months, local control rate at 1 year, intra-cranial distant failure at 1 year, overall survival rate at 1 year, toxicities, radiation necrosis rate, etc.

Conditions

• Brain Metastases, Adult

Interventions

Type	Name	Description
RADIATION	fractionated stereotactic radiotherapy	The prescription is 30 Gy in 5 fractions.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: China