Under way, not recruiting
Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma
NCT04124198 · Christian von Buchwald · Updated 31 Dec 2025
- What is being tested
- Intensity-Modulated Radiation Therapy (IMRT); Cisplatin; Nimorazole.; Transoral Robotic Surgery (TORS) with neck dissection
- For
- Oropharynx Cancer; Oropharynx Squamous Cell Carcinoma; Carcinoma, Squamous Cell; Carcinoma; Oropharyngeal Neoplasms; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms Malignant and Unspecified; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Papillomavirus Infections; Virus Diseases; DNA Virus Infections; Tumor Virus Infections; Quality of Life
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 138 people. The full rules are on the registry page.
- Where
- Denmark (3 sites)
- When
- Starts or started 1 March 2019, ends Dec 2029. Registered 11 Oct 2019.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Aarhus University HospitalAarhus, Denmark
- Copenhagen University Hospital RigshospitaletCopenhagen, Denmark
- Odense University HospitalOdense, Denmark
