Spots Global Cancer Trial Database for HFSRT With Concurrent TMZ for Large BMs
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Trial Identification
Brief Title: HFSRT With Concurrent TMZ for Large BMs
Official Title: Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
Study ID: NCT03778541
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chinese Academy of Medical Sciences, Beijing, Beijing, China
Contact Details
Name: Jianping Xiao, Dr
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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