Lung squamous cell carcinoma
Conditions
Sponsors
First Department of Surgery, Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer. 2) Stage III/IV without indication for curative resection and post-operative recurrent disease. 3) Target lesion is measurable(RECISTver1.1). 4) Patients aged 20 or over. 5) ECOG performance status 0-1. 6) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment: Leukocyte counts, 4,000/mm3 to 12,000/mm3. Neutrophil counts, 2,000/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.0g/dL or over AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Serum bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. Arterial oxygen partial pressure 60 Torr or above. Adequate heart function by ECG. LVEF, 60% or over. 7) Patients without active interstitial pneumonia recognized by chest X-ray. 8) Excepted to live over 12 weeks after administration day. 9) Written informed consent from the patients.
Exclusion criteria
Exclusion criteria: 1) Active infectious disease 2) Patients with fever above 38 degrees. 3) Patients with severe complications. 4) Active concominant malignancies. 5) Patients with symptomatic brain metastasis. 6) Pleural effusion, pericardial effusion and ascites to need treatment 7) Patients with a history of hypersensitivity to the gemcitabine or nedaplation. 8) History of pregnancy or lactation. 9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall Survival Toxicity Feasibility(Dose Intensity) | — |
Countries
Japan
Outcome results
None listed