NCT03564912已完成1 期
Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery
Zhejiang University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年8月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Carcinoma of the intestine confirmed histologically or cytologically
- •Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
- •The ECOG PS score less than or equal to 2 points
- •No chemotherapy of any kind has been performed in the past
- •Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
- •liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN
排除标准
- •Patients with unresectable CRC
- •Patients who have any form of chemotherapy before
- •Participating in or having participated in clinical studies of other drug
- •Patients have second primary malignant tumors of have other malignant tumors in the past five years
- •There is evidence of allergic reaction to drugs in this study
- •A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias
- •Severe active inflammation, including tuberculosis and HIV
- •Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose
- •Drug or alcohol addiction
- •Get pregnant or breastfeed
- •The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems
研究组 & 干预措施
2 week group
Experimental
干预措施: Capecitabine Oral Tablet [Xeloda] (Drug)
3 week group
Active Comparator
干预措施: Capecitabine Oral Tablet [Xeloda] (Drug)
结局指标
主要结局
DFS
时间窗: through study completion, an average of 1 year
disease free survival
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(2 weeks)
研究者
Weijia Fang, MD
director
Zhejiang University
研究点 (1)
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