Lacrimal Drainage Obstruction in Gastric Cancer Patients Receiving Adjuvant S-1 Chemotherapy: A Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of LDO
研究概览
简要总结
S-1 is an effective drug in gastric cancer (GC) for palliative chemotherapy in Eastern and Western patients. Recently, S-1 has been also reported to be an effective adjuvant therapy for GC patients who received D2 surgery in Eastern Asian patients.
Recently, the development of lacrimal drainage obstruction (LDO) caused by S-1 has been reported from some case and small-sized studies. The incidence of developing LDO has been estimated to about 15~20% of patients receiving S-1 therapy in some retrospective studies. However, there is no prospective report on the incidence of LDO in patients receiving S-1 chemotherapy. Moreover, the mechanism of developing S-1-induced LDO has not been systemically studied until now. Suggested mechanism of LDO involves direct secretion of S-1 into the tear.
Therefore, this study was initiated to prospectively investigate the incidence of LDO in GC patients receiving adjuvant S-1 chemotherapy. In addition, the correlation between the development of LDO and the concentration of S-1 (or its metabolites) in tear and plasma will be explored. These results will help clinicians identify patients who are at high risk of developing S-1-associated LDO.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received curative (R0) surgery for GC
- •Patients receiving adjuvant S-1 chemotherapy
- •Patients with adequate major organ functions for chemotherapy
- •Patient who have taken S-1 at least 7 days (for blood and tear sampling)
排除标准
- •Patients who are not candidate for adjuvant S-1 chemotherapy
- •Patients with previous history of LDO
- •Patients with other opthalmologic disease who are not appropriate to be included in this study (i.e., patients using eyedrop medication; patients with dry eye whose tears cannot be sampled)
研究组 & 干预措施
GC patients receiving adjuvant S-1 chemotherapy
干预措施: S-1 (Drug)
结局指标
主要结局
The incidence of LDO
时间窗: The incidence of LDO (1 year)
The cumulative incidence of LDO during the 1 year after adjuvant S1 chemotherapy will be analyzed
次要结局
- Correlation between the concentration of S-1-related chemical compounds and the developement of LDO
研究者
Keun-Wook Lee
Clinical professor
Seoul National University Bundang Hospital