A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer - A feasibility study of oral adjuvant chemotherapy with S-1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
Results: Fifty patients were eligible. The completion rate for the planned 8 courses of S-1 administration was 72.0% (36 patients). Total percentage administration amount was 71.1%. Grade 3 adverse reactions such as neutropenia (4.0%), anorexia (4.0%), thrombopenia (2.0%), anemia (2.0%), elevated total bilirubin (2.0%), hypokalemia (2.0%), nausea (2.0%), and diarrhea (2.0%) were observed, but no grade 4 adverse effects were encountered. Overall and relapse-free survival rates at 3 years were 87.7% and 69.4%, respectively. Conclusions: Postoperative 1-year administration of S-1 seems feasible as oral adjuvant chemotherapy for lung cancer. The oral formulation and low incidence of adverse reactions permit treatment on an outpatient basis. The present study would be reasonable to follow up with a properly powered phase III trial.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.History of drug hypersensitivity. 2.Contraindication of oral S-1 administration (refer appended papaer). 3.Serious surgical or non-surgical complications 4.Active secondary cancer. 5.Watery diarrea. 6.Pregnant or lactating women. 7.Male who has intension to make pregnant 8.Patient to whom primary doctor judjed inadequate to register.