Update on completed and ongoing trials investigating TORS in head and neck oncology

Abstract

Background Human papillomavirus (HPV) has substantially altered the epidemiology and prognosis of oropharyngeal squamous cell carcinomas (OPSCC), with an increasing incidence in younger patients and markedly improved survival outcomes. This shift presents an increasing clinical challenge: how to safely reduce treatment intensity, while maintaining cure and survival rates and minimizing therapy-related toxicity. Transoral robotic surgery (TORS) has emerged as a pivotal strategy in this context, with multiple clinical trials demonstrating promising outcomes. This review aims to summarize registered clinical trials evaluating TORS in OPSCC, identify existing gaps in the literature, and highlight directions for future research. Methods A systematic search of ClinicalTrials.gov was conducted between May 2024 and January 2026 using the search terms “TORS” and “transoral robotic surgery.” The search included completed and analyzed studies, as well as completed but unanalyzed, ongoing or planned studies. Relevant publications were retrieved from databases including ClinicalTrials.gov , PubMed and The Cochrane Library. As this study was based on publicly available literature and trial registries, ethical committee approval was not required. Results A total of 51 clinical trials were identified. We retrieved a total of 23 publications and 3 abstracts. Across these studies, TORS demonstrated oncologic outcomes comparable to radiotherapy in early-stage OPSCC, with distinct but generally acceptable toxicity profiles. Several trials supported the feasibility of treatment de-escalation, including reduced-dose or omission of adjuvant radiotherapy in carefully selected HPV-positive patients, without compromising survival outcomes. Emerging evidence from biomarker-driven studies suggests that circulating cell-free HPV DNA (cfHPVDNA) may enable improved risk stratification and guide personalized de-intensification strategies. In addition, optimization studies indicate that advances in perioperative management and robotic technology may further improve functional outcomes, although high-quality evidence remains limited. Five key areas of research were identified, namely the optimization strategies, TORS as an alternative strategy, TORS for de-escalation, biomarker-driven de-escalation, and induction therapy. Conclusion Transoral robotic surgery demonstrates favorable oncological and functional outcomes, supporting its role as a de-intensification strategy in carefully selected patients with OPSCC. The integration of robust risk stratification methods, including biomarkers such as circulating cell-free HPV DNA (cfHPVDNA), holds promise for optimizing patient selection and tailoring treatment intensity. Continued advancements in robotic technology, along with the development of refined perioperative pain management strategies, may further enhance surgical precision and postoperative recovery.