A randomized phase II study of daily administrations versus alternate-day administrations of TS-1 for the elderly patient with completely resected pathological stage IA(T1bN0M0)-IIIA of non-small cell lung cancer
- Conditions
- on Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000007819
- Lead Sponsor
- Setouchi Lung Cancer Group
- Brief Summary
We enrolled 101 patients in which 97 patients received S-1 treatment. The treatment completion rate at 6 months was 69.4% in Arm A and 64.6% in Arm B (p = 0.67). Among adverse events, anorexia, skin symptoms and lacrimation of any grade were significantly more frequent in Arm B compared with Arm A (p = 0.0036, 0.023 and 0.031, respectively). The 5-year RFS was 56.9% and 65.7% for Arm A and B, respectively (p = 0.22). The 5-year OS was 68.6% and 82.0% for Arm A and B, respectively (p = 0.11).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 101
Not provided
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
- Secondary Outcome Measures
Name Time Method