CompARE:第三阶段随机对照平台试验的研究协议,比较用于中期和高风险口腔癌升级治疗的替代方案
Hisham Mehanna1, Piers Gaunt2, Anthony Kong3
1Institute of Head and Neck Studies and Education (InHANSE), Institute of Cancer and Genomic Sciences, University of Birmingham, B15 2TT, Birmingham, UK. H.Mehanna@bham.ac.uk.
Trials
|January 14, 2024
概括
该CompARE试验调查了中期和高风险口腔癌 (OPC) 的强化治疗方法. 这项研究旨在提高接受新疗法的OPC患者的生存率,而不是标准治疗.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 癌症治疗方法 癌症治疗方法
背景情况:
- 与低风险OPC相比,口腔癌 (OPC) 中期和高风险疾病患者的治疗反应和生存率较差.
- "CompARE"试验通过评估强化治疗策略来解决这种差异.
研究的目的:
- 测试中期和高风险口腔癌患者的替代性,强化治疗方法.
- 为了改善具有挑战性OPC诊断的患者的整体存活率.
主要方法:
- 一个务实的,第三阶段,开放标签,多中心随机对照试验 (RCT) 具有适应性设计.
- 根据HPV状况,瘤阶段 (T1-T4),结节状况 (N0-N3) 和吸烟史来招募OPC患者.
- 标准治疗 (第1臂) 与实验臂的比较,包括诱导杜瓦卢马布,然后是标准治疗和辅助杜瓦卢马布 (第5臂).
主要成果:
- 主要结局指标是整体生存时间和无事件生存期 (EFS).
- 二次结果包括生活质量,毒性,吞功能,输卵管发病率,手术并发症和成本效益.
- 该试验的设计约为7年,为最终分析积累84个事件,并计划进行临时徒劳性分析.
结论:
- CompARE试验旨在提高效率和成本效益.
- 它旨在适应新的数据和新兴治疗方法.
- 最终目标是为OPC患者引入新的治疗选择,改善他们的治疗结果.
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