non-small cell lung cancer
Conditions
Interventions
A: S-1 alternate-day administrations
S-1 is administered orally at Monday, Wednesday, Friday and Sunday for one year.
B: S-1 day1-14, q1w for one year
Sponsors
Setouchi Lung Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven non-small cell lung cancer 2) Neither previous chemotherapy nor radiotherapy before operation 3) Complete resection 4) Pathological stage I (T>2cm) 5) LN dissection (ND2a) 6) Aged 20-75 years old enrollment 7) ECOG PS 0-1 8) Adequate organ function: 1. WBC >=3000/mm3 2. Neutrophil count >= 1,500 /mm3 3. Platelet count >= 100,000 /mm3 4. Hemoglobin >= 9.0 g/dL 5. total bilirubin <= 1.5 mg/dL 6. AST and ALT x 2.5 of upper limit of normal (ULN) 7. Creatinine clearance >=40mL/min 8. PaO2 >= 60mmHg or SpO2 >= 90% 9) At least lobectomy, within 8 weeks after surgery 10) Signed informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy against S-1 2) Severe myelosuppression, renal dysfunction or liver dysfunction 3) Usage of other fluorinated pyrimidine drugs 4) Usage of flucytosine 5) Severe drug allergy 6) Unstable angina or Myocardial Infarction within 6 months 7) Apparent interstitial pneumonitis or pulmonary fibrosis at chest rentogenogram 8) Concomitant therapy Warfarin Potassium or Dabigatran 9) Abnormality of EGG or UCG 10) Severe heart disease, serious psychiatric illness, severe infection, severe other complications 11) Uncontrolled Diabetes Mellitus 12) Ileus 13) Diarrhea 14) Uncontrolled cancer 15) HBs antigen positive 16) Other patients who are unfit for the study as determined by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, RFS, OS | — |
Countries
Japan
Contacts
Public ContactHiromasa Yamamoto
Setouchi Lung Cancer Group Department of Thoracic Surgery, Okayama University Hospital
Outcome results
None listed