Clinical stage III non-small-cell lung cancer NSCLC, unresectable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Non-small cell lung cancer (NSCLC) diagnosed by cytological or histological examination 2) Unresectable locally advanced NSCLC (stage III) 3) Possible for definitive radiotherapy 4) No previous chemotherapy and thoracic radiotherapy 5) At least one measurable lesion 6) Age75 years or more 7) ECOG performance status 0-1 8) Sufficient major organ function 9) Life expectancy; at least 90 days 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Severe infections or complications 3) HBs antigen positive 4) Previous thoracic radiotherapy 5) Interstitial pneumonia or fibrosis on CT 6) Severe emphysema, chronic bronchitis, asthma 7) History of drug-induced pneumonia or severe drug allergies 8) Uncontrolled diabetes despite continuing treatment of insulin 9) Unstable angina or myocardial infarction within 6 months 10) Obvious abnormality of the electrocardiogram 11) Grade 2 or higher peripheral neuropathy 12) Febrile more than or equal to 38 degrees 13) Systemic use of corticosteroid or immunosuppressive drug 14) Severe mental illness 15) Unsuitable for enrollment judged by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of dose limiting toxicity, treatment completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, response rate, progression free survival, 2 year survival rate, overall survival, the first site of disease progression | — |
Contacts
Shizuoka Cancer Center