在steNt减压后对阻断性结肠癌进行新辅助化疗的瘤外结果 (OUTSTAND试验);多中心非劣势随机受控试验的研究协议
Bong-Hyeon Kye1, Ji-Hoon Kim2, Hyung-Jin Kim3
1Department of Surgery, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
BMC cancer
|February 3, 2025
概括
这项研究研究了阻塞性结肠癌手术前使用FOLFOX的新辅助化疗,将结果与自扩展金属支架放置后的直接手术进行比较. 它旨在优化治疗时间和探索循环瘤DNA.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 手术瘤学手术瘤学
背景情况:
- 阻塞性结肠癌的管理通常涉及自扩展金属支架 (SEMS) 作为通往手术 (BTS) 的桥梁.
- 缺乏关于SEMS桥梁期和新辅助化疗在此期间的影响的前性数据.
- 这项研究解决了对阻塞性左侧结肠腺癌的理解上的这些差距.
研究的目的:
- 确定在阻塞性结肠癌中SEMS作为BTS的最佳时间间隔.
- 为了评估新辅助化疗 (FOLFOX) 在 SEMS 桥梁时期的疗效和影响.
- 研究循环瘤DNA (ctDNA) 在指导治疗决策中的作用.
主要方法:
- 一个多中心,随机 (1:1),开放标签,受控试验比较两个治疗手臂.
- 实验组:在手术前进行SEMS安置,然后进行三个周期的新辅助性FOLFOX化疗.
- 对照组:SEMS安置,然后在两周内进行手术.
- 在指定时间点进行循环瘤DNA (ctDNA) 分析.
主要成果:
- 这项研究旨在比较SEMS安置后立即手术和新辅助化疗,然后延迟手术之间的瘤结果.
- 分析重点是桥梁期的持续时间和化疗对长期结果的影响.
- 将评估ctDNA水平,以确定它们作为预测生物标记物的有用性.
结论:
- 结果将指导SEMS安置的最佳时间和在局部晚期结肠癌中应用新辅助化疗.
- 预计结果将为阻塞性结肠癌的患者量身定制的治疗策略提供信息.
- 这项研究将为新辅助化疗对早期瘤传播控制的潜在益处提供关键的见解.
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