NCT03418909

Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

Detailed description

Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery \& Audiology at Copenhagen University Hospital, Rigshospitalet. All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included. Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

Conditions

• Oropharynx Cancer
• Pain
• Swallowing Disorder
• Quality of Life
• Saliva Altered
• Human Papilloma Virus

Interventions

Type	Name	Description
PROCEDURE	Primary Trans Oral Robotic Surgery (TORS)	In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy).
RADIATION	Radio(chemo)therapy	As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two.

Timeline

• Start date: 2017-04-01
• Primary completion: 2021-12-31
• Completion: 2024-06-30
• First posted: 2018-02-01
• Last updated: 2023-03-30

Locations

1 site across 1 country: Denmark