Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial
- Author(s)
- Bahig, H; Rosenthal, DI; Nguyen-Tan, FP; Fuller, DC; Yuan, Y; Hutcheson, KA; Christopoulos, A; Nichols, AC; Fung, K; Ballivy, O; Filion, E; Ng, SP; Lambert, L; Dorth, J; Hu, KS; Palma, D;
- Journal Title
- BMC Cancer
- Publication Type
- Protocol
- Abstract
- BACKGROUND: Radiotherapy, along with laser surgery, is considered a standard treatment option for patients with early glottic squamous cell cancer (SCC). Historically, patients have received complete larynx radiotherapy (CL-RT) due to fear of swallowing and respiratory laryngeal motion and this remains the standard approach in many academic institutions. Local control (LC) rates with CL-RT have been excellent, however this treatment can carry significant toxicities include adverse voice and swallowing outcomes, along with increased long-term risk of cerebrovascular morbidity. A recent retrospective study reported improved voice quality and similar local control outcomes with focused vocal cord radiotherapy (VC-RT) compared to CL-RT. There is currently no prospective evidence on the safety of VC-RT. The primary objective of this Bayesian Phase II trial is to compare the LC of VC-RT to that of CL-RT in patients with T1N0 glottic SCC. METHODS: One hundred and fifty-five patients with T1a-b N0 SCC of the true vocal cords that are n ot candidate or declined laser surgery, will be randomized in a 1:3 ratio the control arm (CL-RT) and the experimental arm (VC-RT). Randomisation will be stratified by tumor stage (T1a/T1b) and by site (each site will be allowed to select one preferred radiation dose regimen, to be used in both arms). CL-RT volumes will correspond to the conventional RT volumes, with the planning target volume extending from the top of thyroid cartilage lamina superiorly to the bottom of the cricoid inferiorly. VC-RT volumes will include the involved vocal cord(s) and a margin accounting for respiration and set-up uncertainty. The primary endpoint will be LC at 2-years, while secondary endpoints will include patient-reported outcomes (voice impairment, dysphagia and symptom burden), acute and late toxicity radiation-induced toxicity, overall survival, progression free survival, as well as an optional component of acoustic and objective measures of voice analysis using the Consensus Auditory-Perceptual Evaluation of Voice. DISCUSSION: This study would constitute the first prospective evidence on the efficacy and safety of VC-RT in early glottic cancer. If positive, this study would result in the adoption of VC-RT as standard approach in early glottic cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759431 Registration date: November 30, 2018.
- Keywords
- Bayes Theorem; Carcinoma, Squamous Cell/diagnostic imaging/*pathology/*radiotherapy; Female; Glottis/diagnostic imaging/*pathology; Humans; Larynx/*radiation effects; Magnetic Resonance Imaging; Male; Neoplasm Staging; Radiotherapy/adverse effects/methods; Tomography, X-Ray Computed; Treatment Outcome; Tumor Burden; Vocal Cords/*pathology/*radiation effects
- Department(s)
- Radiation Oncology
- PubMed ID
- 33888069
- Publisher's Version
- https://doi.org/10.1186/s12885-021-08195-8
- Open Access at Publisher's Site
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Creation Date: 2025-05-23 08:14:05
Last Modified: 2025-05-23 08:15:07