Clinical trial NCT04673929: Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Official title: Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Head and Neck Cancer
Keywords: Recurrent head and neck cancer
transoral robotic surgery
TORS
HNC recurrence
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged over 18 with previous Head and Neck Cancer treated with radiotherapy and undergoing Transoral Robotic Surgery as part of their management for recurrent disease. Surgery performed on or before July 31st 2018.

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.

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

Primary outcomes:
measure: Disease-free Survival at 2 Years
timeFrame: 24 months
measure: Disease-specific Survival at 2 Years
timeFrame: 24 months
Secondary outcomes:
measure: Overall Survival at 2 Years
timeFrame: 24 months
measure: Rate of Gastrostomy Use at 1 Year
timeFrame: 12 months
measure: Rate of Tracheostomy Use at 1 Year
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Head and Neck Unit, Royal Marsden Hospital
state: Greater London
city: London
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
Study officials:
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