A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer
Phase 2
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000011994
- Lead Sponsor
- Setouchi Lung Cancer Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 93
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility
- Secondary Outcome Measures
Name Time Method Safety, RFS, OS