Recruitment

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