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.