JPRN-jRCTs061180089已完成2 期
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 (Setouchi Lung Cancer Group SLCG1201) - SLCG1201
Toyooka Shinichi0 个研究点目标入组 101 人开始时间: 2019年3月22日最近更新:
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
简要总结
Alternate-day oral administration of S-1 for 1 year as adjuvant chemotherapy was demonstrated to be feasible with low toxicity in completely resected pathological stage IA (tumor diameter > 2 cm), IB, II and IIIA NSCLC
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Pathologically proven non-small cell lung cancer
- •2) Complete resection
- •3) Pathological stage IA(T1bN0M0)-IIIA
- •4) At least lobectomy, within 8 weeks after surgery
- •5) LN dissection (ND2a)
- •6) Neither previous chemotherapy nor radiotherapy before operation
- •7) Age of 75 years or older at the time of enrollment
- •8) ECOG PS 0-1
- •9) Adequate organ function:
- •i) WBC >=3000/mm3 and <=12000/mm3,
- •ii) PaO2 >= 60mmHg or SpO2 >= 90%
- •iii) Platelets >=100,000/mm3,
- •iv) Hemoglobin >=9.0g/dL,
- •v) Total bilirubin <=1.5mg/dL,
- •vi) AST(GOT)/ALT(GPT) <=100IU/L,
- •vii) Creatinine clearance >=40mL/min.
- •viii) Creatinine < 1.2mg/dl
- •10) Signed informed consent
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
- •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
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