Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000012098
- Lead Sponsor
- Tokushukai Group Oncology Project
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1) Past history of severe drug hypersensitivity 2) Severe bone marrow suppression, renal dysfunction, or liver dysfunction 3) Treatment history of S-1, except for the cases in which S-1 had been administered as adjuvant chemotherapy and recurrence was observed more than 1 year after thoracic surgery 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer 5) Severe complication such as ileus, interstitial pneumonia, uncontrolled diabetes, heart failure, renal dysfunction, liver dysfunction, active digestive ulcer, and acute myocardial infarction or angina pectoris within six months 6) Diarrhea graded 2 or more 7) Active infectious disease in need of systemic administration of antibiotics 8) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage 9) Uncontrolled symptomatic brain metastasis 10) Systemic administration of steroid 11) Patients with psychiatric disease or symptoms, who seem to have difficulty in participating in the study 12) Any patients judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Response rate, safety and adverse event, 1-year survival rate, overall survival