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Published on: March 18, 2020
Larynx preservation clinical trial design: key issues and recommendations-a consensus panel summary
Jean-Louis Lefebvre1, K Kian Ang,
1Département de Cancérologie Cervico-Faciale, Centre Oscar Lambret, Lille, France. jl-lefebvre@o-lambret.fr
Summary
New guidelines improve Phase III clinical trials for larynx preservation in advanced head and neck cancer. These trials will better evaluate novel treatments for survival and function.
Area of Science:
- Oncology
- Clinical Trial Design
- Head and Neck Cancer Research
Background:
- Locally advanced laryngeal and hypopharyngeal cancer requires optimized treatment strategies.
- Larynx preservation offers a crucial alternative to total laryngectomy, aiming to maintain function.
Framework:
- Development of guidelines for Phase III clinical trials focused on larynx preservation.
- Recommendations based on a multidisciplinary international consensus panel review of existing data.
Implementation:
- Trial population criteria: T2-T3 squamous cell carcinoma, not candidates for partial laryngectomy, age ≤70 years, no laryngeal dysfunction.
- Primary endpoint: Laryngo-esophageal dysfunction-free survival (composite of death, relapse, laryngectomy, tracheotomy, feeding tube dependence).
- Secondary endpoints: Overall survival, progression-free survival, locoregional control, functional outcomes, and quality of life.
Implications:
- Standardized methodologies will enhance the evaluation of novel therapeutic options.
- Improved trial designs are essential for advancing larynx preservation research.
- Focus on survival and functional outcomes will better quantify treatment benefits.
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