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

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 (coprim

SUBMITTER: Marcisz-Grzanka K 

PROVIDER: S-EPMC12630207 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature