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Background <p>The purpose of this study was to examine the eligibility criteria in phase 3 randomized controlled trials (RCTs) in gastric cancer.</p> Methods <p>The analysis included 207 RCTs of systemic treatments, started between 2009 and 2024, and registered at the WHO International Clinical Trials Registry Platform (ICTRP).</p> Results <p>93 (44.9%) trials had an upper age limit of 85&#xa0;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; <i>p</i> &lt; 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 &gt; 1 (coprimary outcome); these criteria were more likely in more recent trials (aOR, 4.49; 95% CI 2.11–9.94; <i>p</i> &lt; 0.001). However, the odds of excluding individuals with ECOG score &gt; 1 were not significantly associated with any type of the investigational treatment including chemotherapy (<i>p</i> &gt; 0.05). Moreover, many trials excluded patients with brain metastases (<i>n</i> = 91; 44%) and those with comorbidities, most frequently liver disorders (<i>n</i> = 170; 82.1%). None of the RCTs excluded patients based on frailty.</p> Conclusions <p>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.</p>

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Eligibility criteria in phase 3 randomized controlled trials in gastric cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月11日

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

摘要

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.