To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Apatinib: Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily. After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg. Radiotherapy: The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy
The intracranial disease progression free survival time
To observe the intracranial disease progression free survival time of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Time frame: tumor assesment every 8 weeks,up to 24 months
Progression free survival time
Baseline to measured date of progression or death from any cause
Time frame: evaluated in 24 months since the treatment began
Overall survival
Baseline to measured date of death from any cause
Time frame: the first day of treatment to death or last survival confirm date ,up to 24 months
Disease control rate
Baseline to measured progressive disease
Time frame: tumor assesment every 8 weeks,up to 24 months
Objective response rate
Baseline to measured stable disease
Time frame: tumor assesment every 8 weeks,up to 24 months
Dosage changes of dexamethasone
To observe the change of the dosage of dexamethasone before and after treatment
Time frame: Dosage changes of dexamethasone every 8 weeks,up to 24 months
Volume change rate of cerebral edema
To observe the change of volume change rate of cerebral edema
Time frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: To observe the safety of therapeutic schedule every 8 weeks,up to 24 months
Cognitive function screening :Mini-mental state examination (MMSE)
The Mini-mental state examination checklist includes 30 problems. Answer the correct question, get 1 points, answer wrong or answer not know, get 0 points, the scale of the total score is 0-30. If the score is 27-30 points, cognitive function is normal; if the score is less than 27, there is cognitive dysfunction. If the score is 21-26 points, there is a mild cognitive impairment. If the score is 10-20 points, there is moderate cognitive impairment. If the score is 0-9 points, there is severe cognitive impairment.
Time frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
Executive function testing:trail marking test(TMT)
The TMT, parts A and B, assesses psychomotor speed and executive function.The A part of the TMT test defined the time range of 0-180 seconds, and the greater the value was, the lower function; the B part of the TMT test defined the time range of 0-300 seconds, and the greater the value, the lower function.
Time frame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
Language function detection :Hopkins verbal learning test-revised(HVLT-R)
The COWA tests verbal fluency and executive function.Within 1 minutes, the subjects say how many words contain one word or within the specified category, each acceptable word counts 1 points, and the repeated words are scored without repetition. The higher the score, the better the function.
Time frame: these neurocognitive function tests assesment every 8 weeks,up to 24 months
Verbal learning and memory:Hopkins verbal learning test-revised(HVLT-R)
The HVLT-R assesses aspects of verbal learning and memory, including immediate recall, delayed recall, and delayed recognition.In the HVLT-R test, the range of learning score and delayed recall score was 0-12 points, and the greater the score, the better the function.
Time frame: these neurocognitive function tests assesment every 8 weeks,up to 24 months