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骨转移临床试验设计中的新考量

New Considerations in the Design of Clinical Trials for Bone Metastases.

作者信息

Lemke Madeline, Lien Karen, Zeng Liang, Popovic Marko, Zhou Michelle, Digiovanni Julia, Chen Emily, Chow Edward

机构信息

Rapid Response Radiotherapy Program, Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Canada.

出版信息

World J Oncol. 2012 Feb;3(1):1-7. doi: 10.4021/wjon445w. Epub 2012 Feb 19.

DOI:10.4021/wjon445w
PMID:29147271
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5649829/
Abstract

Palliative radiotherapy (RT) is prescribed to patients with bone metastases to alleviate symptoms and improve quality of life. The lack of consistent endpoints for such trials has made cross study comparison difficult and has led to contradictory conclusions. The International Bone Metastases Consensus Working Party was established to create a standard set of endpoints and recommendations for future clinical trials. Recommendations were included regarding eligibility criteria, pain assessments, follow-up assessments, timing, as well as radiation techniques. Suggestions were also made to facilitate the ease with which different studies could be compared as well as to encourage widespread consistency in certain aspects of trial design. Investigators conducting clinical trials in bone metastases should continue to adopt these recommendations to ensure consistent guidelines based on the most recent literature.

摘要

姑息性放疗(RT)被用于骨转移患者,以缓解症状并提高生活质量。此类试验缺乏一致的终点指标,这使得跨研究比较变得困难,并导致了相互矛盾的结论。国际骨转移共识工作组的成立是为了创建一套标准的终点指标,并为未来的临床试验提供建议。这些建议包括关于纳入标准、疼痛评估、随访评估、时间安排以及放疗技术等方面。还提出了一些建议,以促进不同研究之间的比较,并鼓励在试验设计的某些方面达成广泛的一致性。进行骨转移临床试验的研究人员应继续采用这些建议,以确保基于最新文献的一致指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16da/5649829/d96f88c27b7f/wjon-03-001-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16da/5649829/d96f88c27b7f/wjon-03-001-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16da/5649829/d96f88c27b7f/wjon-03-001-g001.jpg

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本文引用的文献

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Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases.骨转移姑息性放疗终点的国际共识更新:未来临床试验的应用。
Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
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Quality of life measurement in bone metastases: A literature review.骨转移瘤的生活质量测量:文献综述。
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Clin Oncol (R Coll Radiol). 2011 Aug;23(6):399-406. doi: 10.1016/j.clon.2010.11.011. Epub 2010 Dec 18.
9
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