Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed Non-small cell lung cancer(NSCLC) 2)Previously treated (prior Gefitinib treatment is allowed) 3)Cytologically confirmed carcinomatous meningitis associated with NSCLC 4)Age>=20years 5)ECOG PS 1-3 6)Adequate organ functions 1.WBC >= 3000 /mm3 2.Plt > 75000 /mm3 3.AST and ALT <= 100 IU/ml 4.T-Bil <= 1.5 mg/dl 5.SpO2 >= 90% 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Prior elrotinib treatment with the exception of elrotinib discontinuation for four weeks or more at study enrollment. 2)Active interstitial pneumonia or pulmonary fibrosis on chest CT scan 3)Severe drug allergy 4)Prior radiotherapy to chest within 2 weeks 5)Massive pleural effusion, ascites or pericardial effusion 6)Active infection 7)Continuous watery diarrhea 8)Intestinal paralysis or ileus 9)Symptomatic ophthalmologic disease 10)Current or previous (within the last 1 year) gastrointestinal perforation 11)Severe ulcer 12)Severe cardiac disease 13)Severe psychological disease 14)Pregnant or breast-feeding females or those who declined contraception 15)Inappropriate patients for this study judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Meningitis progression free survival Adverse event Examination of cerebrospinal fluid Performance status Quality of life | — |
Countries
Japan
Contacts
National Kyushu Cancer Center Department of Thoracic Oncology