Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma

Oropharyngeal squamous cell carcinoma (OPSCC) is now the most frequently diagnosed head and neck cancer in Denmark which is mainly due to the increase of Human Papillomavirus (HPV). Patients with HPV-positive OPSCC have a significantly higher survival rate compared to HPV-negative OPSCC. The traditional primary treatment modality in Denmark is Intensity Modulated Radiation Therapy (IMRT), and in advanced stages in combination with chemotherapy. Since 2009, Transoral Robotic Surgery (TORS) has enabled surgeons to perform minimally invasive surgery as an alternative to standard radiotherapy treatment which is considered the primary treatment for OPSCC in many countries. There is a lack of randomised trials comparing long-term functional outcomes after TORS or IMRT. Current data are mostly derived from retrospective studies with selection bias. However, several small retrospective studies have shown promising results when comparing the two treatment modalities in favour of TORS with regards to treatment related swallowing function and quality of life (QoL) without compromising survival outcomes. This study aims to evaluate the early and long-term functional outcomes following two treatment arms 1) TORS combined with neck dissection and 2) IMRT±concurrent chemotherapy with a special focus on swallowing-related QoL.

NCT Number	NCT04124198
Lead Sponsor	Christian von Buchwald Collaborators: Naestved Hospital, Herlev Hospital, Aarhus University Hospital, Odense University Hospital
Conditions	Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, Carcinoma, Squamous Cell, Carcinoma, Oropharyngeal Neoplasms, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type +11 more
Enrollment	138 participants
Start Date	2019-03-01
Primary Completion	2025-12-16 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-31