Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.
Not Applicable
- Conditions
- lung adenocarcinoma
- Registration Number
- JPRN-UMIN000013502
- Lead Sponsor
- Osaka city General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
1)Symptomatic brain metastasis. 2)Patients with untreated brain metastases of size 3cm or more. 3)Active synchronous malignant neoplasm. 4)Uncontrolled pleural effusion, ascites, or pericardial effusion. 5)Active infection requiring systemic administration of antiviral agents, antifungal agents, or antibiotics. 6)Severe complications. 7)Interstitial pneumonia or pulmonary fibrosis detectable on Xray. 8)History of severe drug allergy 9)Patients unable to be treated with oral medication. 10)Pregnancy or lactating patients. 11)Uncontrolled psychotic disease. 12)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 Event Free Survival: EFS
- Secondary Outcome Measures
Name Time Method Response rate, Response rate of brain metastases, Progression free survival, Overall survival, Local therapy free interval for brain metastases, Duration of treatment with erlotinib