NCT02581423已完成4 期
Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults at least 18 years of age
- •Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry
排除标准
- •Macroscopic or microscopic residual tumor
- •Evidence of metastatic disease including tumor cells in ascites
- •Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
- •Active cardiovascular disease
- •Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
- •Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
研究组 & 干预措施
Capecitabine
Experimental
Participants will receive capecitabine for up to approximately 6 months.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to approximately 6 months
Incidence of treatment discontinuation due to AEs
时间窗: Up to approximately 6 months
次要结局
- Incidence of toxocity-related dose reductions(Up to approximately 6 months)
研究者
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