A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece (RETRO-TAS)
2022年3月4日 更新者：Hellenic Study Group of Psychoneuroimmunology in Cancer
A Retrospective Observational Study of Trifluridine/ Tipiracil (TAS-102) in Chemorefractory Metastatic Colorectal Cancer (mCRC) in Greece. Real World Data on Clinical Benefit.
Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.
研究概览
详细说明
The aim of this analysis is to record clinical practice and to collect real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.
Main objectives include to assess physician's choice of treatment in chemoresistant metastatic colorectal cancer with FTD/TPI in third line and beyond In addition, the clinicopathologic features related to metastatic colorectal cancer (focus on molecular profile), duration of treatment, dose modification and toxicity will be analyzed.
研究类型
观察性的
注册 (实际的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Athens、希腊
- Attikon University Hospital
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Athens、希腊、11525
- Athens Medical Group
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Athens、希腊、14564
- General Oncological Hospital "Agioi Anargyroi"
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Athens、希腊
- Agios Savvas Cancer Hospital
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Piraeus、希腊、18537
- Anticancer Hospital "METAXA"
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Thessaloniki、希腊
- Bioclinic
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Crete
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Heraklion、Crete、希腊、70013
- University General Hospital of Heraklion (PAGNI)
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Heraklion、Crete、希腊、71409
- General Hospital "Venizeleio - Pananio"
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Greek patients with mCRC
描述
Inclusion Criteria:
- Age > 18 years
- Histologically confirmed metastatic colorectal cancer
- Available data on previous chemotherapy lines
Exclusion Criteria:
No exclusion criteria have been established for this observational and retrospective study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
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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Progression Free Survival
大体时间：Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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PFS is defined as the time interval from initiation of treatment to the first date of documented tumor progression or death from any cause, whichever occurs first.
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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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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Overall Survival
大体时间：Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
|
Overall survival is defined as the time interval from initiation of treatment to the date of death due to any cause.
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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Progression Free Survival rate at 6 and 8 months
大体时间：Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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PFS rate at 6 and 8 months corresponding to the percentage of patients surviving without any documented progression of the disease at 6 and 8 months after treatment initiation.
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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Disease Control Rate
大体时间：Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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The DCR is defined as the proportion of patients with objective evidence of complete response (CR), the proportion of patients with objective evidence of partial response (PR), and the proportion of patients with objective evidence of stable disease (SD).
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Retrospective data analysis from January 2018 to at least 3 months prior to being included in the study.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：ANNA KOUMARIANOU, PhD、4th Department of Internal Medicine, Attikon University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年6月30日
初级完成 (实际的)
2021年10月31日
研究完成 (实际的)
2021年12月20日
研究注册日期
首次提交
2021年6月28日
首先提交符合 QC 标准的
2021年7月7日
首次发布 (实际的)
2021年7月16日
研究记录更新
最后更新发布 (实际的)
2022年3月7日
上次提交的符合 QC 标准的更新
2022年3月4日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.