non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8,15 every 4weeks. Carboplatin AUC 5 is administered by an infusion lasting 30-60 minutes on day 1 following to na
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically determined non-small cell lung cancer Completely resected 2) Pathological stageIB, IIA, IIB, IIIA 3) at least lobectomy and LN dissection (ND2a) or Elective Lymph Node Dissection 4) Completely resected 5) Neither previous chemotherapy nor radiotherapy before operation 6) ECOG performance status 0 or 1 7) Aged 20-80 years old 8) days before enrollment *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *total bilirubin <or= 1.5 mg/dL *AST and ALT x 2.5 of upper limit of normal (ULN) or les *Serum creatinine <= 1.5 mg/dL 9) Normal electocardiogram 10) Patients are excepted to live at least 3 months 11) Possible to receive chemotherapy within 8 months after surgery 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy for CBDCA/nab-paclitaxel 2) History of Severe drug allergies 3) Myocardial infarction within 6 months 4) Interstitial pneumonia or pulmonary fibrosis detectable on X ray 5)Severe concurrent disease (Ischemic heart disease requiring treatment,arrhythmia,cardiac infarction within 6months before enrollment,hepatic failure,hemorrhagic peptic ulcer,poorly controlled diabetes) 6) History of active double cancerwithin 5years prior to the study 7) HBV-positive patients 8) Patients who are pregnant,considering pregnancy oractaing 9) Other conditions not suitable forthis study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accomplishment of 4 course treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 2yr RFS,OS,RDI,Safty | — |
Countries
Japan
Contacts
Public ContactYoshihiro Miyata
Hiroshima University Surgical Oncology
Outcome results
None listed