Phase II Study of Bevacizumab in Combination with First-line Platinum-Doublet Chemotherapy in Non-squamous NSCLC Patients with Asymptomatic Untreated Brain Metastases.
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000009828
- Lead Sponsor
- Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
(1)Symptomatic brain metastasis (2)>=3cm Untreated brain metastasis (3)Have another active malignancy (4) Current or previous history of hemoptysis (5) Evidence of tumor invading large vessel on imaging (6) Have received radiation therapy to lesions of lung (7) Currently have or have a history of a Ascites ,Pleural effusion or pericardial effusion which requires treatment (8) Symptomatic Brain infarction within 1 year (9) Problematic infection (10) Patients receiving (oral or intravenous) administration of continuous systemic steroids. (11) Sever complications (12) Scheduled operation (13)Active radiation pneumonitis or esophagitis (14) Patients with a history of severe hypersensitivity to drugs used in this trial. (15) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (16) Psychotic disease judged should not to participate the trial (17) Decision of ineligibility by a physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free Survival
- Secondary Outcome Measures
Name Time Method Safety, Overall survival, Response Rate, Response Rate for intracranial metastases