carcinomatous meningitis patients with NSCLC harboring EGFR mutation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. NSCLC, EGFR mutation positive, carcinomatous meningitis patients 2. no treatment of afatinib 3. over 20 years old at the registration 4. ECOG PS 0-3 5. good status of main organ 6. written informed concent
Exclusion criteria
Exclusion criteria: 1. over Grade 2 of diarrhea, a severe gastrointestinal disorder 2. Interstitial lung disease 3. diagnose of malignancy in 5 years 4. Angina and myocardial infarction within six months, heart disorder, severe arrhythmia 5. pleural effusion or ascites which need treatment 6. uncontrolled complications 7. Serious drug allergy history 8. Cannot promise contraception 9. No pregnancy, during nursing 10. A chief physician decide not eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cerebrospinal fluid transitivity of afatinib | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy and safety of afatinib | — |
Countries
Japan
Contacts
Kinki-Chuo Chest Medical Center Internal Medicine