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 - A randomized phase II study of TS-1 adjuvant chemotherapy for the elderly patient with completely resected NSCLC

Setouchi Lung Cancer Group0 个研究点目标入组 101 人开始时间: 2012年4月25日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 101

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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).

研究设计

研究类型: Interventional

入排标准

年龄范围: 75years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•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.

研究者

发起方

Setouchi Lung Cancer Group

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