Non-small cell lung cancer
Conditions
Interventions
Three cycles of Pacritaxel+ Carboplatin followed by maintenance Gemcitabine in 21-day cycles until progression disease
Three cycles of Gemcitabine+Carboplatin followed by maintenance Gemcitabine in 2
Sponsors
Respiratory, Osaka University Hospital
OULCSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients 2) Ptients who have measurable lesion or evaluable lesion by RECIST 3) Stage three/four without any indications for radiotherapy 4) Patients aged from 20 to 75years older 5)ECOG PS 0-1 6) Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 4,000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 10 g/dL AST/ALT <=100IU/L T.Bil <= 1.5 g/dL Ccr >=60mL/min, sCr: x 1.2 of upper limit of normal or less. SpO2 >= 95% as room air 7)Patients are excepted to live over 3 months after administration day. 8)Written informed consent from the patients
Exclusion criteria
Exclusion criteria: 1)Having the bleeding tendency which is clear in clinic 2)An agreement is not obtained for support therapy such as transfusion etc 3)Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor 4) History of severe heart disease (uncontrollable arrythmia, uncontrollable angina pectoris, congestive heart failue, etc within 6 months) 5)Patients with jaundice 6)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 7)Patiens has pleural effusion, pericardial effusion and ascites to need treatment for 8)Acute inflammatory disease 9)Uncontrollable diabetes mellitus and hypertenson 10)Patients with mental disorders seems to be in need of treatment or during treatment with psychotropic drugs 11)Sub-cases considered severe intestinal obstruction, or intestinal obstruction clinically 12)Patients with complications considered serious to interfere with the performance of treatment 13)Patients with suspected infection 14)Patients with a history of hypersensitivity to (such as cyclosporine injection)-containing preparations (Kuremohoru EL &reg;) polyoxyethylene castor oil 15)Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity 16)Patients with brain metastases with the clinical symptoms 17) Patients who underwent radiation therapy to the lesions can be evaluated 18) The patient has drug allergies 19)Serious Patients with) will (possibly during pregnancy and pregnancy or lactating 20) principal investigator cases that are deemed inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival: PFS | — |
Countries
Japan
Outcome results
None listed