HFSRT With Concurrent TMZ for Large BMs
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Brain Metastases
- Chemotherapy
- Radiotherapy
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone groupMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 ov...
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.
Tracking Information
- NCT #
- NCT03778541
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jianping Xiao, Dr Cancer Institute and Hospital, Chinese Academy of Medical Sciences