NCT03338075

FSRT Combined With TMZ for Large BMs: a PSM Study

Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

Detailed description

A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.

Conditions

• Brain Metastases
• Radiotherapy
• Chemotherapy

Interventions

Type	Name	Description
RADIATION	fractionated stereotactic radiotherapy	The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-11-09
• Last updated: 2017-11-09