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Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04673929
Acronym
RECUT
Enrollment
278
Registered
2020-12-17
Start date
2020-02-14
Completion date
2021-10-01
Last updated
2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Head and Neck Cancer

Keywords

Recurrent head and neck cancer, transoral robotic surgery, TORS, HNC recurrence

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.

Interventions

None listed

Sponsors

Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Disease-free Survival at 2 Years24 monthsDisease-free survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure
Disease-specific Survival at 2 Years24 monthsDisease-specific survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

Secondary

MeasureTime frameDescription
Overall Survival at 2 Years24 monthsOverall survival at 2 years - number of living participants at end of 2 year follow up - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure
Rate of Gastrostomy Use at 1 Year12 monthsRate of gastrostomy use at 1 year - number of participants having a gastrostomy post surgery
Rate of Tracheostomy Use at 1 Year12 monthsRate of tracheostomy use at 1 year

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Patients With HNC Recurrence Treated With TORS
Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
278
Total278

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath73
Overall StudyDid not reach the 2 year follow up point (observational study)43

Baseline characteristics

CharacteristicPatients With HNC Recurrence Treated With TORS
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
112 Participants
Age, Categorical
Between 18 and 65 years
166 Participants
Age, Continuous61 years
Performance Status Scale - Head and Neck Normalcy of diet77.1 units on a scale
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United Kingdom
278 Participants
Sex: Female, Male
Female
56 Participants
Sex: Female, Male
Male
222 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
115 / 278
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Disease-free Survival at 2 Years

Disease-free survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With HNC Recurrence Treated With TORSDisease-free Survival at 2 Years111 Participants
Primary

Disease-specific Survival at 2 Years

Disease-specific survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With HNC Recurrence Treated With TORSDisease-specific Survival at 2 Years219 Participants
Secondary

Overall Survival at 2 Years

Overall survival at 2 years - number of living participants at end of 2 year follow up - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With HNC Recurrence Treated With TORSOverall Survival at 2 Years192 Participants
Secondary

Rate of Gastrostomy Use at 1 Year

Rate of gastrostomy use at 1 year - number of participants having a gastrostomy post surgery

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With HNC Recurrence Treated With TORSRate of Gastrostomy Use at 1 Year109 Participants
Secondary

Rate of Tracheostomy Use at 1 Year

Rate of tracheostomy use at 1 year

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With HNC Recurrence Treated With TORSRate of Tracheostomy Use at 1 Year105 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026