Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients enrolled in this trial had histologically or cytologically confirmed NSCLC who are in-operable or not candidates for thoracic radiation, if they had not received previous chemotherapy, had measurable disease, and had a life expectancy of at least 3 months. Additional entry criteria were age 20=< years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 4,000/mm3, <12,000/mm3, neutrophil count>2,000/mm3, hemoglobin concentration > 9.5g/dL, platelet count > 100,000/mm3), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase[AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr) functions.
Exclusion criteria
Exclusion criteria: Patients were excluded if they had any active concomitant malignancies,infections, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 6 months,uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,safety, toxicity, QOL | — |
Countries
Japan
Contacts
Niigata University Medical and Dental Hospital Bioscience Medical Research Center