NCT00278889已完成2 期
A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of colon or rectal cancer,
- •Received prior systemic therapy for cancer,
- •Cancer must have progressed during or after first treatment
排除标准
- •Prior treatment with a VEGF inhibitor,
- •Poorly controlled hypertension
研究组 & 干预措施
1
Active Comparator
Bevacizumab + FOLFOX
干预措施: 5-fluorouracil (Drug)
1
Active Comparator
Bevacizumab + FOLFOX
干预措施: Leucovorin (Drug)
1
Active Comparator
Bevacizumab + FOLFOX
干预措施: Oxaliplatin (Drug)
1
Active Comparator
Bevacizumab + FOLFOX
干预措施: Bevacizumab (Drug)
2
Experimental
AZD2171 + FOLFOX
干预措施: AZD2171 (Drug)
2
Experimental
AZD2171 + FOLFOX
干预措施: 5-fluorouracil (Drug)
2
Experimental
AZD2171 + FOLFOX
干预措施: Leucovorin (Drug)
2
Experimental
AZD2171 + FOLFOX
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Randomisation to data cut-off date of November 2007
Number of months from randomisation to the earlier date of objective progression or death
次要结局
- QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)(Randomisation to data cut-off date of November 2007)
- Objective Response Rate(Randomisation to data cut-off date of November 2007)
- Overall Survival(Randomisation to data cut-off date of 30 January 2009)
- Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)(Randomisation to data cut-off date of November 2007)
- QOL: Time to Worsening of Treatment-free Survival (TFS)(Randomisation to data cut-off date of November 2007)
- QOL: Time to Worsening of Clear Cell Sarcoma (CCS)(Randomisation to data cut-off date of November 2007)
研究者
研究点 (2)
Loading locations...
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