EUCTR2004-001926-26-GB进行中(未招募)1 期
XERXES: Examining the role of early neoadjuvant and synchronous Erbitux in pre-operative chemo-radiotherapy using Xeloda followed by excisional surgery. A phase I/II dose escalation study of intravenous erbitux (cetuximab) in combination with 5 day weekly oral Xeloda (capecitabine) and preoperative radiotherapy in rectal cancer. - XERXES
niversity College London0 个研究点目标入组 22 人开始时间: 2005年6月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Biopsy proven adenocarcinoma of the rectum (tumour <15cm from anal verge); Indication for pre-operative chemoradiotherapy by virtue of partially fixed/unresectable disease and locally advanced disease (T3/T4) where the preoperative MRI confirms the surgeon is unlikely to perform a R0 resection; WHO performance status 0 or 1; Age =18 and fit for surgery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent; Previous radiotherapy to the pelvis; Previous chemotherapy or radiation for rectal cancer
研究者
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