SUPRATOL: a multicenter trial to evaluate functional results of transoral laser microsurgery (TLM) in patients with supraglottic carcinomas.

Introduction Aim of the trial is to investigate, whether the positive functional results reported in past monocentric retrospective studies are reproducible in a prospective randomized trial.

Setting Thirty-one head and neck cancer-treating centers throughout Germany.

Participants Patients with previously untreated T2/T3 SCC of the supraglottic larynx, fit for TLM +/-, uni- or bilateral selective neck dissection, and adjuvant R (C) T were recruited.

Methods Pretherapeutic diagnostics, surgical, and adjuvant treatment were standardized. Primary endpoint: Time to free of aspiration after end of treatment, measured with FEES (fiberoptic endoscopic evaluation of swallowing) and defined as grade < 6 of PAS (penetration-aspiration-scale) according to Rosenbeck. Secondary endpoints: local control, larynx preservation, disease-specific and overall survival, dysphagia and voice-related quality of life, complications of treatment, and number of tracheostomies and PEG-feeding tubes.

Results 203 patients were screened and 115 patients were included in total. Thirteen patients were excluded after inclusion for various reasons. The primary and secondary endpoints of the remaining 102 patients were evaluated using survival analyzes. Trial results will be reported descriptively and discussed in detail.

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Publication History

Article published online:
10 June 2020