NCT02075086Unknown2 期
Angiogenic Switch as Predictor of Response to Chemotherapy in Patients With Metastatic Colorectal Cancer
Grupo Hospital de Madrid1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev chemotherapy combinations .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage IV colorectal adenocarcinoma.
- •Age ≥ 18 years .
- •Measurable disease by RECIST criteria.
- •Life expectancy ≥ 6 months.
- •Candidate to receive treatment with first-line chemotherapy.
- •Availability of tumor tissue.
排除标准
- •Patients who have received prior treatment with first-line chemotherapy for metastatic disease.
- •Patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or Bev.
- •Patients receiving anticoagulant oral treatment.
- •Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually
- •Patients with bone disease as the only manifestation of the disease.
研究组 & 干预措施
Chemotherapy treatment
Experimental
Chemotherapy treatment with Xelox or Xeliri and bevacizumab
干预措施: Xelox or Xeliri Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 1 year
Days from cycle one day one to progression
次要结局
- Feasibility(2 years)
研究者
Sofia Perea, Director Clinical Trials Unit.
MD, PhD
Grupo Hospital de Madrid
研究点 (1)
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