NCT01039506已完成不适用
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,376
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic colorectal cancer (adenocarcinoma)
- •UGT1A1 genotyped patients
- •Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)
排除标准
- •Contraindication of CPT-11
- •Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
- •Patients to receiving CPT-11 as adjuvant chemotherapy
- •History of pelvic irradiation
研究组 & 干预措施
UGT1A1 genotyped patients
UGT1A1 genotyped patients receive CPT-11 based regimens
干预措施: CPT-11 based regimens (Drug)
结局指标
主要结局
Progression free survival
时间窗: Within 3 years
Percentage of participants alive without disease progression
次要结局
- Safety events(Within 3 years)
- Overall survival(At 3 years)
- Time to treatment failure(Within 3 years)
- Response rate(from Day 1 (treatment) through disease progression (within 3 years))
- Disease control rate(Within 3 years)
研究者
研究点 (1)
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