在胃癌的第三阶段随机对照试验中符合资格标准
Katarzyna Marcisz-Grzanka1, Danuta Kłosowska2, Marek Harhala3
1Department of Clinical Oncology and Radiotherapy, Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Wawelska 15, 02-034, Warsaw, Poland.
概括
胃癌临床试验往往有严格的年龄和性能状态限制,排除许多患者. 这些标准需要修订,以改善老年人和患有并发症的人的入学率.
科学领域:
- 在瘤学瘤学.
- 临床试验设计 临床试验设计
- 胃肠病学 胃肠病学
背景情况:
- 胃癌临床试验对于推进治疗选择至关重要.
- 了解符合条件的标准是确保试验通用性和患者获取的关键.
研究的目的:
- 分析胃癌第三阶段随机对照试验 (RCT) 的资格标准.
- 确定常见的排除标准及其对患者招募的影响.
主要方法:
- 对207个胃癌第三阶段RCT进行了系统审查.
- 数据来源于世卫组织国际临床试验注册平台 (ICTRP).
- 分析重点关注于2009年至2024年期间启动的试验.
主要成果:
- 近一半 (44.9%) 的试验的上限年龄为85岁或更低.
- 66.7%的患者被排除在外,东部合作瘤组 (ECOG) 的得分大于1.
- 观察到大脑转移 (44%) 和并发症 (82.1%) 的排除率很高.
结论:
- 第三阶段胃癌RCT的资格标准通常是限制性的.
- 建议旨在扩大对老年患者,表现不佳患者和并发性疾病的招生范围.
- 调整标准可以提高试验的包容性,而不会影响参与者的安全.
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