Non-small cell lung cancer
Conditions
Interventions
VNR 25mg/m2 day1,8 CDDP 40mg/m2 day1,8 q4W 4cycle
S-1 80-120mg/day day1-14 CBDCA AUC5 day1 q4W 4cycle
Sponsors
Fukushima medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically confirmed stage II-IIIA NSCLC 2)Completely resected NSCLC by lobectomy or more with lymph node dissection 3)No prior therapy without surgery for NSCLC 4)Age of 20 years or older 5)ECOG performance status 0-1 6)With adequate major organ functions within 14 days before randomization, as defined below: *White blood cell count >= 3,500/mm3 *Neutrophil count >= 2,000/mm3 *Hemoglobin >= 9.0 g/dL *Platelet count >= 100,000/mm3 *Total bilirubin <= 1.5 mg/dL *AST <= 100IU/L *ALT <= 100IU/L *Creatinine <= 1.5 mg/dL *CCr >= 60 mL/min * SpO2 >= 92% 7) Be able to start adjuvant chemotherapy within 10 week after surgery 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Contraindication with S-1, carboplatin, vinorelbine and cisplatin 2) With large cell neuroendocrine carcinoma(LCNEC) 3) With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 4) With double cancer, multiple cancer 5) With Serious post-operative complications 6) With severe drug allergies 7) With serious concurrent disease 8) With serious diarrhea 9) Current use of flucytosine 10) Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 11) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two year relapse-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Relapse-free Survival Completion rate of protocol treatment Safety | — |
Countries
Japan
Contacts
Public ContactHiroyuki Suzuki
Fukushima Medical University Hospital Department of Chest Surgery
Outcome results
None listed