completely resected pathological stage II/IIIA non-small cell lung cancer
Conditions
Interventions
Platinum based adjuvant chemotherapy followed by maintenance UFT for 2 years. UFT is administered orally at 320mg/m2/day for 2 years consecutive day.
Sponsors
Department of Surgery, Division of Chest Surgery, St.Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically-proven non-small cell lung cancer 2) pathological stage II,IIIA 3) completely resected NSCLC 4) completely resected by at least lobectomy 5) LN dissection (ND2a) or Elective Lymph Node Dissection 6) Without previous therapy for non-small cell lung cancer 7) PS 0 or 1 8) age 20-80 9) adequate organ function WBC >=4,000/mm3 and <=12,000/mm3 neutrophil >=2,000/mm3 Hb >=10.0g/dl Plt >=100,000/mm3 T-bil <=1.2mg/dl AST/ALT <=100IU/L Ccr >=60mL/min(Cockcroft-Gault) PaO2 >=70mmHg or SpO2 >=95% 10) possible to receive platinumu based chemotherapy within 10 weeks after surgery 11) written informed consent
Exclusion criteria
Exclusion criteria: 1) not recovered from surgical complications 2) active infection such as bacterial infection 3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infraction within 6 months 5) patients with uncontroled complications 6) grade 2 or greater peripheral neuropathy 7) Active another neoplasm 8) pregnant or lactating women 9) concomitant therapy with other fluoropyrimmidine 10) pneumonectomy 11) Patient who is judged to be inappropriate as subject to this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, relative performance | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival , Overall survival , safety | — |
Countries
Japan
Contacts
Public ContactAtsushi Mochizuki
St.Marianna University School of Medicine Division of Chest Surgery
Outcome results
None listed