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Clinical Trial Summary

A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.


Clinical Trial Description

A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03778541
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Jianping Xiao, Dr
Phone +8613811026919
Email jpxiao8@163.com
Status Recruiting
Phase Phase 3
Start date December 3, 2018
Completion date December 3, 2022

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