Non-small cell lung cancer patients with postoperative recurrence or stage3-4 with chemotherapy treatment history
Conditions
Interventions
docetaxel 35mg/m2 biweekly + TS-1 80-120mg/day from day1 to day 7 in two weeks
docetaxel 60mg/2 triweekly
Sponsors
Kanto respiratory disease study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histological diagnosis has been diagnosed with non-small cell lung cancer or in cytology 2)Non-small cell lung cancer of unresectable, cases of Stage 3B or 4 Stage or radical irradiation is not possible 3)Patients with measurable disease 4)Chemotherapy treatment history are cases of one regimen over the previous 5)It has passed more than 4 weeks if the four days or more chemotherapy if due to molecular targeted agents before, more than two weeks if UFT, an anti-tumor agent of the other is being used 6)Performance status(ECOG) is 0-2 7)Age of patients over 20 years old 8)Cases survival of 3 months or more is expected 9)Cases (bone marrow, lung, liver, and kidney) function has been held sufficient major organs
Exclusion criteria
Exclusion criteria: 1)Patients with severe infection is suspected or there is fever cases are complicated by severe infection 2)Cases where there is intention or possibility pregnant women, pregnancy and breast-feeding 3)Patients having double cancer of activity of simultaneity, and multiple cancer or metachronous 4)Patients with severe drug allergy 5)Cases of bleeding (hemorrhagic enteritis, ischemic colitis, necrotizing enterocolitis) and gastrointestinal ulceration 6)Cases is determined pulmonary fibrosis or interstitial pneumonia is a problem in clinical CT images from 7)Cases are complicated by lung disease emphysema of advanced, chronic bronchitis severe, such as bronchial asthma 8)Cases with pleural effusion in need of treatment of drainage, etc., and storage of pericardial effusion 9)Brain metastasis of symptomatic 10)Patients with a myocardial infarction within 3 months after onset (diabetes that is difficult to control, liver damage (cirrhosis), renal failure, angina, and arrhythmia) and serious complication 119Patients with a history of administration TS-1 or DTX before treatment 12)Case it is determined to be inappropriate other attending physician to safely performed this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS) | — |
Countries
Japan
Contacts
Public Contactkunihiko kobayashi
Saitama medical university international medical center Respiratory medicine
Outcome results
None listed