Chemo-Na&
Conditions
Interventions
Carboplatin AUC = 5(day1)+ S-1 80mg/m2 (day1~14) q3weeks 6 cycles followed by +S-1 80mg/m2(day1~14) q3weeks until disease progression
Sponsors
Dept. of Respiratory Medicine, Osaka University Hospital
OSAKA-LCSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed squamous cell lung cancer 2.Stage IIIB/IV without any indications for radiotherapy, or recurrent disease after surgery 3.Measurable disease 4.Except for the surgical treatment for non-small cell lung cancer, patients have not been conducted prior treatment (radiation therapy, and chemotherapy)However, radiation therapy is not applied radiation field in the primary tumor, two weeks after irradiation final at the time of registration it is acceptable) 5.Age 20=< 6.ECOG performance status of 0 to 1 7.Patiants who can take in drug orally 8.Adequate organ function, evaluated within 14 days before enrollment as; WBC >= 3,500 /mm3 Neu >= 1,500 /mm3 Plt >= 100,000 /mm3 hemoglobin >= 9.0 g/dL AST (GOT) , ALT (GPT) =< 100 IU/L T. bil =< 1.5 mg/dL Cr >= 1.2mg/dL SpO2 >= 90% or >= 60 torr 9.Expected to live over 12 weeks after administration days 10.Written informed consent from the patients
Exclusion criteria
Exclusion criteria: 1.Adjuvant chemotherapy 2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia. 3.History of severe drug allergy 4.Active synchronous malignancies 5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 6.Severe complication 7.Metastasis to CNS 8.Patients with chest radiation treatment is required to reach the lung irradiation 9.Treated by flucytosine (5-FC) 10.Women with a possibility of pregnancy, pregnant or lactating 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Progression-free survival of maintenance treatment, Overall survival, Frequency and grade of adverse event | — |
Countries
Japan
Contacts
Public ContactTakashi Kijima
Osaka University Hospital Dept. of Respiratory Medicine
Outcome results
None listed