This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-small cell lung cancer by assessing the treatment response, perilesional edema, neurological symptoms and quality of life.
This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-small cell lung cancer by assessing the treatment response, neurological symptoms and quality of life. Patients will receive Bevacizumab(7.5mg/kg, q3w, i.v.) before and after FSRT(40Gy in 10 fractions or 30Gy in 5 fractions) to the brain metastases. The primary endpoint was intra-cranial progression-free survival (IPFS). Secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life (QOL) scores, and toxicities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Bevacizumab: Patients will receive Bevacizumab (7.5mg/kg, q3w, IV) before and after FSRT. Fractionated stereotactic radiotherapy(FSRT): 40 Gy/10 fractions or 30 Gy/5 fractions for GTV will be delivered to brain metastases.
Sun Yat-sen University
Guangzhou, China
Intracranial progression-free survival
IPFS was calculated from the completion of radiotherapy until the first occurrence of either intracranial progression or death.
Time frame: 1 year
overall survival (OS)
Time frame: 1 year
progression-free survival (PFS)
Time frame: 1 year
Rate of participants with perilesional edema of brain metastases evaluated by T2-weighted MRI
Time frame: 1 year
Quality of life evaluated by EORTC quality of life questionnaire
Quality of life evaluated by EORTC quality of life questionnaire(QLQ-C30 and QLQ-BN20)
Time frame: 6 months
Rate of patients with treatment-related adverse events evaluated by CTCAE v5.0
Time frame: 1 year
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