Trial Design, Endpoints and Results Reporting in Interventional Laryngeal Cancer Trials: A Registry‐Based Analysis
OBJECTIVES: To characterize trial design, endpoint emphasis and public results reporting in interventional laryngeal cancer studies. DESIGN: Registry-based descriptive study of trial records. SETTING: ClinicalTrials.gov; records were retrieved on 28 July 2025. PARTICIPANTS: Interventional trials retrieved using the term 'laryngeal cancer' and with a documented start date between 1988 and 2025. MAIN OUTCOME MEASURES: Trial phase, planned enrolment, design features, intervention strategies, registered endpoint domains, results posting and discontinuation. RESULTS: We identified 404 trials. Most were early-to mid-phase with modest enrolment, and masking was recorded in 10.6%. Randomization was documented in 34.7% overall and was more frequent in 2009-2025 than in 1988-2008. Across three study eras, the proportion of trials specifying survival endpoints increased from 34.2% to 68.4%. Quality-of-life or patient-reported endpoints increased from 11.0% to 36.8%, and swallowing endpoints increased from 6.3% to 17.1%. Voice endpoints remained uncommon (3.8%-6.6%), and 21 trials (5.2%) specified an explicit larynx-preservation endpoint. Results were posted for 23.5% of trials, and 16.1% were discontinued. CONCLUSIONS: Registrations increasingly reflect survival and patient-centred priorities, although explicit larynx-preservation endpoints and publicly posted results remain uncommon. Future trials may benefit from larynx-specific designs, consistent assessment of larynx preservation and function with adequate follow-up, and timely dissemination of results.
Authors
- Jin Wang (ORCID: https://orcid.org/0000-0003-3027-681X)
- Ziqi Yang (ORCID: https://orcid.org/0009-0003-6629-0709)
- Junfeng Wu (ORCID: https://orcid.org/0009-0001-8952-0373)
- Yihao Pei (ORCID: https://orcid.org/0009-0004-8949-519X)
- Fance Meng (ORCID: https://orcid.org/0009-0002-2144-8034)
- Jianmei Han
Institutions
- Guiyang Medical University (CN)
- Jiading District Central Hospital (CN)
- Affiliated Hospital of Guizhou Medical University (CN)
- Medical College of Jinzhou Medical University (CN)
- Jinzhou Medical University (CN)
Publication Details
- Journal
- Clinical Otolaryngology
- Published
- 2026-09-30
- DOI
- https://doi.org/10.1111/coa.70174
- Primary Topic
- Head and Neck Cancer Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00