squamous cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Definitively diagnosed with having squamous cell lung cancer by the specimens histologically or cytologically. 2)Clinical Stage 3B which curative radiotherapy is not indicated,4 or postoperative recurrence. 3)No prior chemotherapy. *Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted. 4)No prior radiotherapy for primary lesions.(Palliative local radiation except for primary lesion is permitted.) 5)At least one measurable lesion. 6)Age of 75 year or older. 7)ECOG Performance status of 0-1. 8)Sufficient major organ function as below *Neutrophil count>=1500/mm3 *Platelet count>=100000/mm3 *Hemoglobin>=9.0g/dl *total bilirubin<=1.5mg/dl *AST<=ULNX2.5 *ALT<=ULNX2.5 *Serum creatinine<=1.5mg/dl *PaO2>=60 Torr or more(or SpO2 >=95% or more) 9)Life expectancy of at least 3months 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)With active other organ cancer 2)With active infection 3)With fever equal to or more than 38C 4)With mental disorder 5)With symptomatic brain metastasis 6)Pleural and peritoneal effusion likely to require surgical intervention,or pericardial effusion 7) Systematic steroids , immunosuppressive medication or poorly controlled diabetes 8)Grade 2 or higher peripheral neuropathy 9)Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 10)poorly controlled hypertension 11)Ischemic heart disease or cardiac infarction within 6 months before enrollment 12)History of severe drug allergies 13)Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival,response rate,toxicities,disease control rate | — |
Countries
Japan
Contacts
Osaka City General Hospital Department of clinical oncology