Author:
Bahig Houda,Rosenthal David I.,Nguyen-Tan Félix-Phuc,Fuller David C.,Yuan Ying,Hutcheson Katherine A.,Christopoulos Apostolos,Nichols Anthony C.,Fung Kevin,Ballivy Olivier,Filion Edith,Ng Sweet Ping,Lambert Louise,Dorth Jennifer,Hu Kenneth S.,Palma David
Abstract
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
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
Reference67 articles.
1. Ferlay JSI, Ervik M, Dikshit R, Eser S, Mathers C, et al. GLOBOCAN 2012 v1.0, cancer incidence and mortality worldwide: IARC cancerbase no. 11. Lyon: International Agency for Research on Cancer; 2013.
2. 2016 CCSsSCoCS. Toronto, Ontario, Canada: Canadian Cancer Society. 2016.
3. Grant DG, Salassa JR, Hinni ML, Pearson BW, Hayden RE, Perry WC. Transoral laser microsurgery for carcinoma of the supraglottic larynx. Otolaryngol Head Neck Surg. 2007;136(6):900–6. https://doi.org/10.1016/j.otohns.2006.12.015.
4. Outzen KE, Illum P. CO2-laser therapy for carcinoma of the larynx. J Laryngol Otol. 1995;109(2):111–3. https://doi.org/10.1017/S0022215100129421.
5. Ambrosch P. The role of laser microsurgery in the treatment of laryngeal cancer. Curr Opin Otolaryngol Head Neck Surg. 2007;15(2):82–8. https://doi.org/10.1097/MOO.0b013e3280147336.
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