Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

NCT ID: NCT04673929

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-14
• Study Completion Date: 2021-10-01

Brief Summary

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

Detailed Description

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and is increasing in incidence. Squamous cell carcinomas (SCC) account for the majority of these HNCs. An increasing number of these SCCs are being found to be associated with the Human Papilloma Virus (HPV) which has also been shown to be associated with a more favourable outcome. These HPV related cancers tend to affect younger patients with fewer comorbidities. As such, we are finding a larger cohort of patients are surviving for longer after treatment for their primary cancers.

HNC patients are over 11 times more likely to experience a second head and neck primary cancer than the general population over 20 years of follow up (SIR 11.2, 95% CI [10.6-11.8]). In addition to second primaries, patients may suffer from residual disease after treatment for their initial primary, identified within a 12 month period, or recurrent disease, cancer at the same site identified within 5 years. Treatment for all of these cancers, which we will broadly term 'recurrent' cancers for the purposes of this study, can be complex. Commonly, radiotherapy will have formed part of the treatment regime at either the primary site or to the neck for these patients. Radiotherapy causes fibrosis in the irradiated tissues, reducing tissue pliability, contributing to trismus and reducing healing potential at the effected sites. This can pose significant challenges to any further surgical intervention, which may form the mainstay of any subsequent management if re-irradiation is not an option or not indicated. Surgery must then look to be as minimally invasive as possible in order to maximise functional outcomes and reduce disruption of affected tissues.

Options for surgery have traditionally involved transmandibular and transcervical routes. More recently transoral routes have been adopted as endoscopic instruments become more widely available and adopted. Transoral Robotic Surgery (TORS) is the latest development in the field which confers some significant advantages to the surgeon and to the patient. For the surgeon, the endoscopic view is binocular, giving a close objective lens and excellent depth perception. Further, the instruments have wrists which sit within the body cavity, allowing manipulation of the tissues beyond the direct line of sight through the oral stoma. For the patient, there is less disrupted tissue if access incisions are avoided, reducing the volume of tissue that would be susceptible to scarring which can affect swallowing function or lead to fistula formation.

However, there are little data to show oncological and functional outcomes are acceptable following TORS surgery for recurrent cancers. This is in part as it is a relatively new technology and in part because whilst increasingly common, the absolute number of surgeries performed remains relatively low at individual centres. Published outcomes have shown 2 year disease-free survival rates around 75%. The RECUT study aims to use a collaborative methodology to document the outcomes from TORS for recurrent HNC being performed at a number of high volume centres across the globe.

Conditions

Recurrent Head and Neck Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients with Head & Neck Cancer recurrence treated with Transoral Robotic Surgery

Report of disease-free survival at 2 years for patients with Head \& Neck Cancer recurrence treated with Transoral Robotic Surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Aged over 18
• Previous Head & Neck Cancer treated with radiotherapy
• Undergoing Transoral Robotic Surgery as part of their management for recurrent disease
• Surgery performed on or before July 31st 2018.

Exclusion Criteria

• Transoral Robotic Surgery used in a diagnostic setting only
• Nasopharyngeal and thyroid cancers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Head and Neck Unit, Royal Marsden Hospital

London, Greater London, United Kingdom

Royal Marsden Hospital NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CCR5156

Identifier Type: -

Identifier Source: org_study_id