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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGintracranial progression free survival (IPFS) rate
IPFS was defined as the interval from the beginning of radiation to any intracranial progression
Time frame: up to 2 years
local control rate
the control rate of treated lesions
Time frame: up to 2 years
Brain metastasis-specific survival (BMSS) rate
BMSS was defined as the internal from the beginning of RT to death caused by BM
Time frame: up to 2 years
overall survival (OS) rate
OS was defined as the internal from the beginning of RT to death caused by any reason
Time frame: up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria
the toxicities caused by RT and (or) Chemotherapy
Time frame: acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT
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