non-small cell lung cancer
Conditions
Interventions
S-1 50-120 mg/day, day1-14 every 3 weeks
Sponsors
Kitasato University School of Medicine Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer. 2)Clinical stage IIIB, IV or recurrent disease after surgery. 3)With at least one or more measurable lesion by RECIST. 4)Aged 70 years or older. 5)ECOG performance status of 0 or 1. 6)No prior chemothearpy or radiotherapy for non-small Cell Lung Cancer. 7)Adequate organ function. 8)Oral intake is possible. 9)Life expectancy more than 3 months. 10)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Active lung disease such as interstitial pneumonia or pulmonary fibrosis. 2)Uncontrollable pleural or pericardial effusion or ascites. 3)Simultaneous or metachronous double cancers. 4)Severe complications. 5)Symptomatic brain metastases. 6)The case suspected of infection with feaver. 7)Mental disease or psychotic manifestation. 8)A history of serious drug allergy. 9)A history of sever allergic reaction with S-1 10)A history of adjuvant chemotherapy including S-1. 11)Being treated with other pyrimidine fluoride antineoplastic agents. 12)Being treated with flucytosine. 13)Any patients judged by the investigator to be unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, Safety, To explore EGFR status and K-ras status related to the effect. | — |
Countries
Japan
Contacts
Public ContactAkira Takakura
Kitasato University School of Medicine Department of Respiratory Medicine
Outcome results
None listed