Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Clinical Research Center for Solid Tumor, Korea
With
Seoul National University Hospital
Korean Cancer Study Group
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age \>18
2. Histologically or pathologically proven non-small cell lung cancer (NSCLC)
3. Leptomeningeal carcinomatosis confirmed by CSF cytology
4. A patients with EGFR mutation (including exon 19 deletion, L858R)
5. ECOG performance status 0-3
6. Expected life time more than at least 4 weeks
7. A patients who signed the informed consent prior to the participation in the study
8. Chemotherapy-naïve patient is eligible
9. Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases
You may not be if
1. A pregnant or lactating patient
2. A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
3. A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
4. A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
5. A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
6. A patient with history of allergic reaction to gefitinib or erlotinib
7. The following laboratory test results:
* Number of absolute neutrophils counts (ANC) \< 1.0ⅹ109/L
* Number of platelets \< 50 ⅹ109/L
* AST, ALT \> 2.5 ⅹupper limit of normal
* Total bilirubin \> 1.5 ⅹupper limit of normal
* Serum creatinine \> 1.5 ⅹupper limit of normal
8. A patient with serious disease as followings
* Uncontrolled cardiac arrhythmia
* History of myocardial infarction within 6 months prior to the initiation of study
* Neurological or psychiatric disorder including dementia or uncontrolled seizure
9. A patient who refused to sign the informed consent
Clareo Health | A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer
