Phase 2 study of efficacy and safety of concurrent WBRT with erlotinib and followed by erlotinib plus bevacizumab in patients with newly diagnostic brain metastatisis stage IV non-sq NSCLC
- Conditions
- newly diagnostic brain metastatisis stage IV non-sq NSCLC
- Registration Number
- JPRN-UMIN000014740
- Lead Sponsor
- Shinshu University Hospital, Comprehensive Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intracranial Progression-free Survival ( iPFS)
- Secondary Outcome Measures
Name Time Method 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