Status:
UNKNOWN
HFSRT With Concurrent TMZ for Large BMs
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Brain Metastases
Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
- the number of BMs ≤ 3
- the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
- Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
- Age: 18-75 years old;
- Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results\<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.
Exclusion
- patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
- unable or unwilling to comply with the study protocol;
- patient whose survival expectancy was less than 3 months;
- the large BM locates in brainstem;
- patient who anticipated in other clinical trials of brain metastases;
- the large lesions have been treated with SRT in other hospitals;
- pregnant patients or female patients whose HCG is positive.
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2022
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT03778541
Start Date
December 3 2018
End Date
December 3 2022
Last Update
July 23 2019
Active Locations (1)
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1
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021