Previously treated non-small cell lung cancer
Conditions
Interventions
administration of TS-1
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed Stage IIIB,IV non- squamous non-small cell lung cancer 2)Stage III,IV non-small cell lung cancer without any indications for radiotherapy 3)75<= years 4)Performance Status (ECOG):0-1 5)Previously treated one or more chemotherapy regimens 6)A life expectancy of more than 3 months 7)Patients who can take in drug orally 8)Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 Neutrophils >= 1,500/mm3 Platelets >= 100,000/mm3 Hemoglobin >= 9.0 g/dL Total bilirubin <= 1.5mg/mL AST and ALT, x2.5 of upper limit of normal(ULN) or less Serum creatinine <= 1.5mg/dL Creatinin crealance>=50mL/min
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 2) Massive pleural or pericardial effusion,ascites 3) History of active double cancer within 5 years prior to the study. 4) Patients having active other cancers. 5) Ileus, Interstitial 6) Uncontrolled diabetes mellitus 7) Cardiac infarction or unstable angina within 6 months 8) Symptomatic brain metastases 9) Concomitant therapy with flucytocine, phenytoin or Warfarin Potassium 10) Serious psychiatric illness 11) History of severe hypersensitivity(>=Grade3) 12) History of using 5-FU o 13) Patient who is not candidates for TS-1 14) HBV-positive patients 15) Evaluated to be ineligible by a physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1yr OS,PFS,DCR | — |
Countries
Japan
Contacts
Public ContactKazunori Fujitaka
Hiroshima University Hospital Department of Respiratory Medicine
Outcome results
None listed