RECUT: Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04673929

Collaborator

(none)

200

Enrollment

Locations

19.5

Anticipated Duration (Months)

100

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

Condition or Disease	Intervention/Treatment	Phase
Recurrent Head and Neck Cancer

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Actual Study Start Date :

Feb 14, 2020

Actual Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
patients with HNC recurrence treated with TORS Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS

Outcome Measures

Primary Outcome Measures

Disease-free survival at 2 years [24 months]
Disease-free survival at 2 years

Secondary Outcome Measures

Overall survival at 2 years [24 months]
Overall survival at 2 years
Disease-specific survival at 2 years [24 months]
Disease-specific survival at 2 years
Rate of gastrostomy use at 1 year [12 months]
Rate of gastrostomy use at 1 year
Rate of tracheostomy use at 1 year [12 months]
Rate of tracheostomy use at 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Aged over 18
Previous HNC treated with radiotherapy
Undergoing TORS as part of their management for recurrent disease
Surgery performed on or before July 31st 2018.

Exclusion Criteria:

TORS used in a diagnostic setting only
Nasopharyngeal and thyroid cancers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Head and Neck Unit, Royal Marsden Hospital	London	Greater London	United Kingdom	SW3 6JJ
2	Royal Marsden Hospital NHS Foundation Trust	London		United Kingdom	SW3 6JJ