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临床试验/NCT01815879
NCT01815879Unknown不适用

Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project

Andrew Kennedy1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.

研究概览

简要总结

Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up.

详细描述

Investigator initiated multi-institutional retrospective review of clinical and radiographic outcomes after 90Y resin microsphere radioembolization for metastatic colorectal liver metastases in the USA. The target is for at least 1,000 evaluable patients with 12+ weeks follow up. Objectives:

Independent data collection and reporting of pre treatment and 12 week post treatment clinical, radiographic and radiation parameters and outcomes in patients treated in the USA from 2002-2010. Data beyond 12 weeks will be collected and highly desirable, however as a minimum all patients will have 12 week follow up.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received 90Y resin microsphere radioembolization for metastatic colorectal cancer with liver metastases between November 2010 and March 2011 in the USA. Patients must have at least 12 weeks of follow up.

排除标准

  • Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.

结局指标

主要结局

Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.

时间窗: 3 months

Multiple systems monitored for side effects possibly related to liver radiotherapy.

次要结局

  • Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.(3 months)

研究者

发起方
Andrew Kennedy
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Andrew Kennedy

Principal Investigator and Sponsor-Investigator

Sarah Cannon

研究点 (1)

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