A Feasibility Study of Adjuvant Chemotherapy With Oral Fluoropyrimidine S-1 for Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Completion rate
研究概览
简要总结
The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small cell lung cancer. The investigators presume they can achieve high completion rate with low toxicity.
详细描述
Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT, gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day according to body surface area (BSA): BSA <1.25 m2, 80 mg/day; BSA >1.25 m2 but <1.5 m2, 100 mg/day; and BSA >1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals, starting within 4 weeks after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC with histological proof.
- •Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
- •No prior treatment except for surgery.
- •Sufficient oral intake.
- •Performance status (PS) 0 or
- •Patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; AST and ALT, less than twice the normal limits at each institution; BUN, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (Ccr))
排除标准
- •History of drug hypersensitivity.
- •Contraindication of oral S-1 administration (refer appended paper).
- •Serious surgical or non-surgical complications
- •Active secondary cancer.
- •Watery diarrhea.
- •Pregnant or lactating women.
- •Male who has intention to make pregnant
- •Patient to whom primary doctor judged inadequate to register.
研究组 & 干预措施
S-1
Single arm of the patients who received complete resection of pathological stage IB, II, or IIIA Non-small cell lung cancer
干预措施: S-1 (Drug)
结局指标
主要结局
Completion rate
时间窗: One year
次要结局
- Incidence and grade of adverse reactions(One year)
研究者
Tomoshi Tsuchiya
Senior Assistant Professor
Nagasaki University