Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed NSCLC 2)stage III NSCLC with no prior chemotherapy, radiotherapy or surgery (open biopsy is allowed) 3)unresectable lung cancer 4)V20 <=95% or equivalent dose to it 5)oral intake is possible 6)aged 20 years or older, under 75 years 7)ECOG PS 0-1 8)adequate organ function -WBC count >=4000/mm3 -neutrophil count >=2000/mm3 -hemoglobin >=9.5g/dL -platelet count >=100000/mm3 -AST and ALT <=100IU/L -total bilirubine level <=1.5mg/dL -serum creatinine <=1.5mg/dL -creatinine clearance >=60mL/min -PaO2 >=70torr 9)written informed consent
Exclusion criteria
Exclusion criteria: 1)T3N1 2)SVC syndrome with difficulty of a lot of intravenous infusion 3)clinically significant contralateral hilar lymph node metastasis, carcinomatous pericardial or pleural effusion, or carcinomatous lymphangitis 4)concurent serious infection or complications 5)continuous watery diarrhea 6)significant interstitial pneumonitis or pulmonary fibrosis in chest CT 7)concomitant cancers within 5 years 8)concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine 9)inadequately controlled diabetes mellitus 10)HBs Ag is positive 11)a history of serious drug allergy 12)mental disease or psychotic manifestation 13)pregnancy, breast feeding, wish of future bearing or hesitation in contraception 14)other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| over all survival, progression free survival, adverse events, dose intensity | — |
Countries
Japan
Contacts
Yokohama Municipal Citizen's Hospital Department of Respiratory Medicine