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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\u20130.26;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Only 3 (1.4%) trials were specifically dedicated to older patients. 138 (66.7%) trials excluded patients with Eastern Cooperative Oncology Group (ECOG) score\u2009&gt;\u20091 (coprimary outcome); these criteria were more likely in more recent trials (aOR, 4.49; 95% CI 2.11\u20139.94;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). However, the odds of excluding individuals with ECOG score\u2009&gt;\u20091 were not significantly associated with any type of the investigational treatment including chemotherapy (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&gt;\u20090.05). Moreover, many trials excluded patients with brain metastases (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200991; 44%) and those with comorbidities, most frequently liver disorders (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009170; 82.1%). None of the RCTs excluded patients based on frailty.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats: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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10120-025-01653-3","type":"journal-article","created":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T12:52:37Z","timestamp":1757595157000},"page":"1232-1240","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Eligibility criteria in phase 3 randomized controlled trials in gastric cancer"],"prefix":"10.1007","volume":"28","author":[{"given":"Katarzyna","family":"Marcisz-Grzanka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danuta","family":"K\u0142osowska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marek","family":"Harhala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5256-1959","authenticated-orcid":false,"given":"Jan","family":"Borysowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,11]]},"reference":[{"key":"1653_CR1","doi-asserted-by":"publisher","first-page":"2395","DOI":"10.1200\/JCO.2004.08.154","volume":"22","author":"I Chau","year":"2004","unstructured":"Chau I, Norman AR, Cunningham D, Waters JS, Oates J, Ross PJ. 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