Phase
Condition
Brain Metastases
Neoplasm Metastasis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brainmetastases by pathologic histology or cytology
Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab)after diagnosed brain metastases
Appraisable disease, the presence of at least three lesions if longest diameter <10 mmby brain MRI
Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Lifeexpectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit ofnormal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULNin case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according toCockcroft-gault formula).
Patients should be contraceptive during the period of the trial
Exclusion
Exclusion Criteria:
Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with apredominant squamous component.
History of haemoptysis
Evidence of tumour invading major blood vessels on imaging.
Patient was received irradiation of brain. Patient with meningeal metastases wereconfirmed by MRI or cytology test of cerebrospinal fluid.
Previous radiotherapy.
Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6months prior to study start or history of serious bleeding complications.
Major surgical procedures within 4 weeks prior to study entry.
Minor surgery, including insertion of an indwelling catheter, within 24 hours prior tothe first bevacizumab infusion.
Non-healing wound, active peptic ulcer or bone fracture.
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscesswithin 6 months of enrollment
Study Design
Connect with a study center
Sun Yat-sen University of Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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