Eligibility criteria in phase 3 randomized controlled trials in gastric cancer.

IF 5.1 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastric Cancer Pub Date : 2025-09-11 DOI:10.1007/s10120-025-01653-3

Katarzyna Marcisz-Grzanka, Danuta Kłosowska, Marek Harhala, Jan Borysowski

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引用次数: 0

Abstract

Background: The purpose of this study was to examine the eligibility criteria in phase 3 randomized controlled trials (RCTs) in gastric cancer.

Methods: The analysis included 207 RCTs of systemic treatments, started between 2009 and 2024, and registered at the WHO International Clinical Trials Registry Platform (ICTRP).

Results: 93 (44.9%) trials had an upper age limit of 85 years of age or lower (coprimary outcome). In multivariable analysis, these limits were less likely in RCTs with the sites located in North America (adjusted odds ratio [aOR], 0.06; 95% confidence interval [CI] 0.01-0.26; p < 0.001). Only 3 (1.4%) trials were specifically dedicated to older patients. 138 (66.7%) trials excluded patients with Eastern Cooperative Oncology Group (ECOG) score > 1 (coprimary outcome); these criteria were more likely in more recent trials (aOR, 4.49; 95% CI 2.11-9.94; p < 0.001). However, the odds of excluding individuals with ECOG score > 1 were not significantly associated with any type of the investigational treatment including chemotherapy (p > 0.05). Moreover, many trials excluded patients with brain metastases (n = 91; 44%) and those with comorbidities, most frequently liver disorders (n = 170; 82.1%). None of the RCTs excluded patients based on frailty.

Conclusions: The eligibility criteria in phase 3 RCTs in gastric cancer are fairly strict. Recommendations presented in this article will allow the investigators to improve the enrollment of some clinically relevant populations of patients, especially older persons, individuals with inadequate performance status, and those with comorbidities, without substantially compromising the safety of trials participants.

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胃癌3期随机对照试验的资格标准。

背景：本研究的目的是检查胃癌3期随机对照试验（rct）的资格标准。方法：分析包括207项全身治疗的随机对照试验，于2009年至2024年间开始，并在世卫组织国际临床试验注册平台（ICTRP）注册。结果：93项（44.9%）试验的年龄上限为85岁或更低（主要结局）。在多变量分析中，这些限制在位于北美的随机对照试验中不太可能出现(调整优势比[aOR]， 0.06； 95%置信区间[CI] 0.01-0.26; p < 1（主要结局）；这些标准在最近的试验中更有可能出现（aOR, 4.49; 95% CI 2.11-9.94; p < 1），与包括化疗在内的任何类型的试验性治疗均无显著相关性（p < 0.05）。此外，许多试验排除了脑转移患者（n = 91, 44%）和合并症患者，最常见的是肝脏疾病（n = 170, 82.1%）。没有一项随机对照试验因虚弱而排除患者。结论：胃癌3期随机对照试验的入选标准相当严格。本文提出的建议将使研究者能够在不损害试验参与者安全性的前提下，改善一些临床相关患者人群的入组，特别是老年人、表现不佳的个体和有合并症的患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gastric Cancer 医学-胃肠肝病学

CiteScore

14.70

自引率

2.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.