This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of FSRT plus TMZ for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm:40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f.
concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2\*5d, q28d, 6cycles
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
intracranial progress free survival rate
defined as no progress of the treated lesions and no distant progress in the brain
Time frame: up to 2 years
Overall survival rate
Time frame: up to 3 year
progress free survival rate
Time frame: up to 1 year
local control rate
Time frame: up to 1 year
disease control rate (DCR)
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
Time frame: 2-3 months after radiation
adverse event
assessed by CTCAE criteria, v4.0 and RTOG criteria of the central nervous system
Time frame: from the day of radiation to the end of adjuvant TMZ,up to 6 months
causes of death
collect the data of causes of death and analyze
Time frame: from the day of radiation to death date, up to 5 years
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