Non-small cell lung cancer
Conditions
Interventions
Vinorelbin 25mg/m2 day 1,8 zoledronate 4mg day1 every 3 weeks
Sponsors
Niigata Lung Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 histologically or cytologically confirmed NSCLC 2 no prior chemotherapy 3 measurable disease, and had 4 a life expectancy of at least 3 months. 5 age >=70 years 6 performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale 7 adequate organ function adequate bone marrow (leukocyte count > 3,000/mm3, neutrophil count > 1,500/mm3, hemoglobin concentration > 9.0g/dL, platelet count > 100,000 /mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and corrected Ca 8.0<<11.5mg/dL
Exclusion criteria
Exclusion criteria: 1 active concomitant malignancies,infections 2 symptomatic brain metastases 3 past history of severe allergic reactions to drugs 4 interstitial pneumonia identified by chest X-ray 5 bone metastasis or hypercalcemia required immediate treatment 6 other serious complications, such as uncontrolled angina pectoris,myocardial infarction, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRE: Skeletal Related Events | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to SRE, toxicity, response rate, PFS, OS, pain score, and QOL | — |
Countries
Japan
Contacts
Public ContactHirohisa Yoshizawa
Niigata University Medical and Dental Hospital Bioscience Medical Research Center
Outcome results
None listed