Recurrent Head and Neck Cancer
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival at 2 Years | 24 months | Disease-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 Years | 24 months | Disease-specific survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at 2 Years | 24 months | 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 |
| Rate of Gastrostomy Use at 1 Year | 12 months | Rate of gastrostomy use at 1 year - number of participants having a gastrostomy post surgery |
| Rate of Tracheostomy Use at 1 Year | 12 months | Rate of tracheostomy use at 1 year |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With HNC Recurrence Treated With TORS Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS | 278 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 73 |
| Overall Study | Did not reach the 2 year follow up point (observational study) | 43 |
Baseline characteristics
| Characteristic | Patients 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, Continuous | 61 years | — |
| Performance Status Scale - Head and Neck Normalcy of diet | 77.1 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 type | EG000 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
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With HNC Recurrence Treated With TORS | Disease-free Survival at 2 Years | 111 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With HNC Recurrence Treated With TORS | Disease-specific Survival at 2 Years | 219 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With HNC Recurrence Treated With TORS | Overall Survival at 2 Years | 192 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With HNC Recurrence Treated With TORS | Rate of Gastrostomy Use at 1 Year | 109 Participants |
Rate of Tracheostomy Use at 1 Year
Rate of tracheostomy use at 1 year
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With HNC Recurrence Treated With TORS | Rate of Tracheostomy Use at 1 Year | 105 Participants |