Non-small Cell Lung Cancer
Conditions
Interventions
Induction chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) plus carboplatin at the dose of area under the curve 5 (Day 1) every 3 weeks, up to 4 cycles.
Sponsors
Tokushukai Group Oncology Project
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age of 75 years or older 2) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) 3) Incurable NSCLC with stage IIIB or stage IV (including postoperative recurrence) 4) Patients with previously untreated NSCLC. Patients who have previously undergone EGFR-TKI (Gefitinib or Erlotinib) as first line chemotherapy are considered suitable for inclusion as second line chemotherapy. Patients are also considered suitable for inclusion, who have undergone thoracic surgery and platinum-based adjuvant chemotherapy more than 12 months earlier. 5) Performance Status (Eastern Cooperative Oncology Group: ECOG) 0-2 6) Both measurable and non-measurable lesions are acceptable as far as objective lesions are detectable by means of X-ray, CT, MRI, and RI within 28days before the entry. 7) Capable of oral intake 8) Adequate organ functions within 14 days before the entry i) White blood cell count 3500/mm3 or over ii) Neutrophil count 1500/mm3 or over iii) Platelet count 100,000/m3 or over iv) Hemoglobin 9.0g/dL or over v) Total bilirubin 2.0mg/dL or under vi) AST/ALT 100IU/L or under vii) PaO2 60Torr or over, or SpO2 90% or over viii) Creatinine clearance 50mL/min or over 9) Estimated life expectancy of at least 12 weeks 10) With written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, safety and adverse event, 1-year survival rate, overall survival | — |
Countries
Japan
Contacts
Public ContactTAKEDA Takayuki
Uji-Tokushukai Medical Center Department of Respiratory Medicine
Outcome results
None listed