Background Patients with gastrointestinal (GI) cancers experience a high symptom burden due to the effects of both cancer and treatment. As such, trials assessing symptom burden and supportive interventions are crucial. Here, we characterise the landscape of phase III GI cancer clinical trials and explore study outcomes centred on the patient’s quality of life (QoL).
Methods We searched ClinicalTrials.gov for phase III randomised controlled trials (RCTs) registered between 2000 and 2017 that are assessing a therapeutic intervention in adult patients with cancer and grouped trials by GI disease sites.
Results Overall, we identified 76 phase III trials specific to GI cancers that enrolled a total of 53 725 patients. When analysing the primary outcomes measured, the vast majority of studies (n=71, 86%) measured disease-related endpoints such as progression-free survival or overall survival. All trials had a secondary endpoint that measured adverse events, but only 30 trials (39%) included QoL measures as secondary endpoints. Of the 30 trials that included QoL secondary endpoints, only 16 (53%) reported these results. Only five trials (7%) assessed interventions aimed at supportive measures impacting disease-related or treatment-related toxicity. None of the supportive trials included QoL as a primary endpoint and only two of these trials (40%) included QoL as a secondary endpoint.
Conclusions Most GI cancer trials failed to incorporate patient-centred outcomes or QoL measures when studying new interventions. These findings call for greater integration of patient-reported metrics, which may lead to better care and outcomes for patients with GI malignancies.
- gastrointestinal (upper)
- gastrointestinal (lower)
- supportive care
- quality of life
- symptoms and symptom management
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RK and JAJ are joint first authors.
EBL and CMT are joint senior authors.
Contributors RK, JAJ, IMS, EBL and CMT: study concept and design. RK and JAJ: acquisition of data. RK, JAJ, BDM, PD, ACK, IMS, EBL and CMT: analysis and interpretation of data; drafting of the manuscript and critical revision of the manuscript for important intellectual content.
Funding CMT is supported by funding from NIH under award R01CA227517-01A1, Cancer Prevention & Research Institute of Texas (CPRIT) grant RR140012, V Foundation (V2015-22), the Childress Family Foundation, Mark Foundation and the McNair Foundation. This work was supported by the NIH under award P30 CA016672.
Competing interests PD reports personal fees from Adlai Nortye, personal fees from MD Anderson Cancer Center Madrid Spain, outside the submitted work. ACK acts as a consultant to Aravive, Inc and also serve as a consultant.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon request
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