ACTRN12606000112561已完成3 期
Phase III Randomised Study of Cetuximab and Best Supportive Care Versus Best Supportive Care Alone in survival of Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.
ational Cancer Institute of Canada0 个研究点目标入组 500 人开始时间: 2004年7月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Histologically confirmed colorectal cancer- Metastatic disease- Epidermal growth factor receptor (EGFR)-positive by immunochemistry- Measurable or evaluable disease- Not amenable to standard curative therapy- Best supportive care is the only available option- Must have received a prior thymidylate synthase inhibitor (eg: fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting- Combination therapy with oxaliplatin or irinotecan allowed- Must have failed* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens.
排除标准
- •No symptomatic CNS metastases.- Any condition that does not permit compliance with the protocol*NOTE: Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen.
研究者
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