Metastatic Colorectal Cancer Liver Metastases Outcomes After Resin 90Y Microsphere Radioembolization in the USA Evaluation Project (MORE)
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Tennessee
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Nashville、Tennessee、美国、37203
- Contact Sarah Cannon
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who received glass 90Y microsphere radioembolization for metastatic colorectal liver metastases.
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：追溯
队列和干预
团体/队列 |
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Control Group
Retrospective review of clinical data on at least 1,000 evaluable US patients with 12+weeks follow up that were treated with 90Y resin microsphere radioembolization for metastatic colorectal liver metastases
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Adverse events at day 0-90 post 90Y therapy using CTCae 3.0 criteria.
大体时间：3 months
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Multiple systems monitored for side effects possibly related to liver radiotherapy.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Radiographic response rate at 90 days (+/- 45 days) from treatment day, compared to pretreatment scans.
大体时间：3 months
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Pretreatment planning scans (-45 to -1 day) compared to post radiotherapy scans of the liver, PET/CT not recommended, prefer MRI with Gd or CT with contrast, 3 phase, with rescanning in similar fashion at day 90 post treatment.
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3 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Andrew S Kennedy, MD, FACRO、SCRI Development Innovations, LLC
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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