newly diagnostic brain metastatisis stage IV non-sq NSCLC
Conditions
Interventions
concurrent WBRT with erlotinib WBRT 30 Gy / 10fxs / 2 weeks or 37.5 Gy / 15fxs / 3weeks erlotinib 150 mg/day, day 1-14 followed by erlotinib plus bevacizumab erlotinib 150 mg/da
Sponsors
Shinshu University Hospital, Comprehensive Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed non-sq NSCLC patients 2) Patients with brain metastases confirmed by MRI 3) The presence of measureable brain metastasis by RECIST 4) Age moer than 20 and less than 80 years old 5) Performance status 0-2 (ECOG) 6) Adequate organ function WBC more than 3000/mm3 Neutrophil more than 1500/mm3 Platelet more than 75000/mm3 Hemoglobin more than 9.0 g/dL AST, ALT less than 2.5 times of the upper limits of normal level Total bilirubin less than 1.5 mg/dL Creatinine less than 1.2 mg/dL SpO2(Room air) more than 93% Proteinuria less than 2+ 7) Interval Palliative radiotherapy (exclude chest) >= 2weeks Surgery >= 8weeks Chest drainage>= 2weeks 8) Life expectancy more than 3 months 9) Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1) Current history of hemosputum within one month 2) Past given the radiation therapy for chest 3) Symptomatic meningeal dissemination 4) Patients who have previously treated with EGFR TKI within 6 months 5) Obvious interstitial pneumonia , fibroid lung confirmed by chest X-ray 6) Patients unable to be treated with oral medication 7) Therapeutic anticoagulation; regular use of aspirin (>325 mg/day) 8) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis 9) Infectious disease that required systemic therapy 10) Fever over 38 11) Uncontrolled pleural effusion, ascites, or pericardial effusion 12) Active synchronous malignant neoplasm 13) History of drug allergy that may influenced with this treatment 14) Severe GI disease 15) Suspected of other severe clinical conditions or abnormal laboratory values 16) Uncontrolled psychotic disease 17) Pregnant, Lactating or possibility of pregnancy 18) Patients who were judged inappropriate to entry this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Progression-free Survival ( iPFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial Objective Response Rate (iORR), Overall Response Rate (ORR), Progression-free Survival (PFS), Overall Survival (OS), maximal reduction ratio of brain metastasis, efficacy and safety according to EGFR mutation status | — |
Countries
Japan
Contacts
Public ContactShigeru Sasaki
Shinshu University Hospital Comprehensive Cancer Center
Outcome results
None listed