inoperable locally advanced non-small-cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histologically and/or cytologically proven NSCLC No prior surgery, chemotherapy, or radiotherapy Age ≤ 75 Unresectable stage IIIA or IIIB ECOG performance status 0 or 1 Measurable disease Ample bone marrow, lung, hepatic, and renal function Signed informed consent
Exclusion criteria
Exclusion criteria: Involvement of contralateral hilar node, dissemination to pleura/pericardium, or malignant pleural/pericardial effusion Active concomitant malignancy History of chemotherapy or thoracic radiotherapy for previous malignancy Interstitial pneumonia Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Judging of inappropriate condition for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: maximum-tolerated doses and the recommended dose for phase II Phase II: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, overall survival, progression-free survival, pattern of progression/relapse, treatment compliance | — |
Countries
Japan
Contacts
Okayama Lung Cancer Study Group Coordinating Office Department of Respiratory Medicine, Okayama University Hospital