NCI直肠-门工作组就直肠癌临床试验设计的共识建议达成共识
Hagen F Kennecke1, Rebecca Auer2, May Cho3
1Medical Oncology, Providence Cancer Institute Franz Clinic, Portland, OR, USA.
专家们就设计局部晚期直肠癌的未来临床试验达成共识,强调全新辅助疗法和患者参与治疗决策.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
背景情况:
- 局部晚期直肠癌的最佳管理正在发展.
- 国家癌症研究所直肠门工作组召集了专家,以指导未来的临床试验设计.
研究的目的:
- 发展对未来临床试验的关键要素的共识,在局部先进的直肠癌.
- 确定关于试验设计参数的共识和分歧的领域.
主要方法:
- 一个专家小组使用了代的Delphi方法来审查82个问题和子问题.
- 在放射治疗,新辅助疗法,患者感知,特殊人群和试验设计元素方面寻求共识.
主要成果:
- 关于在试验中使用全新辅助疗法 (TNT) 作为对照组达成共识.
- 关于增加患者参与治疗选择和确定非手术治疗候选人的协议.
- 确定了调查循环瘤DNA (ctDNA) 和定义试验终点的优先事项.
结论:
- 关于在局部晚期直肠癌中设计未来临床试验的优先事项,存在实质性的协议.
- 该共识为推进研究和优化患者护理提供了一个框架,通过精心设计的试验来优化患者护理.
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