Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Conditions: Recurrent Head and Neck Cancer
Sponsor: Royal Marsden NHS Foundation Trust

THE RECUT STUDY 
 
transoral Robotic surgery for rECurrent tumours of the 
Upper aerodigestive Tract 
 
Protocol version: 
 
 
1.8 
Date: 
 
 
29th July 2021 
 
 
 
 
Sponsor: 
 
 
The Royal Marsden NHS foundation Trust 
 
 
 
Fulham Road, London SW3 6JJ 
 
 
 
 
CCR number: 
 
 
5156 
IRAS number: 
 
 
268830 
 
 
 
 
Chief Investigator: 
 
 
Professor Vinidh Paleri 
Consultant Head & Neck and Thyroid Surgeon, 
   The Royal Marsden Hospital, London 
Professor of Robotic & Endoscopic Head & Neck Surgery, 
   The Institute of Cancer Research, London 
 
 
 
 
Clinical Research  
Fellow: 
 
 
Mr John Hardman 
Specialty Registrar in Otorhinolaryngology, 
   The Institute of Cancer Research, London 
   The Royal Marsden Hospital, London 
 
 
 
 
Proposed  
co-investigators 
(alphabetical): 
 
 
Patrick Aidan 
Surender K Dabas 
John de Almeida 
Umamaheswar Duvvuri 
David Hamilton 
Tamer A Ghanem 
Philippe Gorphe 
Neil D Gross 
F Chris Holsinger 
J Scott Magnuson 
Brett Miles 
Eric J Moore 
Gouri Pantvaidya 
Vincent Vander Poorten 
Niclas Rubek 
Christian Simon 
 
Grainne Brady 
Justin Roe 
Sarah Stephen 
 
 
 
 
Statistical support 
 
 
Research Data Management and Statistics Unit 
 
 
 
The Royal Marsden NHS Foundation Trust 
 
 
 
 
Contact: 
 
 
vinidh.paleri@rmh.nhs.uk 
 
 
 

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CCR: CCR5156 
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TABLE OF CONTENTS 
 
 
1 
Version history ........................................................................................................... 3 
2 
Proposed co-investigators ......................................................................................... 4 
3 
Project summary ........................................................................................................ 6 
4 
Signature Page ........................................................................................................... 7 
5 
Rationale and background information ..................................................................... 8 
6 
Aim, objectives and outcome measures .................................................................... 9 
7 
Study design and setting .......................................................................................... 10 
8 
Participant eligibility criteria .................................................................................... 11 
9 
Study procedures and methodology ........................................................................ 12 
10 Statistics and data analysis ....................................................................................... 15 
11 Problems anticipated ............................................................................................... 17 
12 Ethical considerations .............................................................................................. 18 
13 Project management team ...................................................................................... 19 
14 Authorship policy ..................................................................................................... 20 
15 Funding .................................................................................................................... 21 
16 Table of acronyms .................................................................................................... 22 
17 References ............................................................................................................... 23 
 

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CCR: CCR5156 
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1  VERSION HISTORY 
 
Protocol version no. 
Date 
Version 
0.1 
2019/02/11 
First draft, as distributed for feedback 
0.2 
2019/03/21 
Updated co-investigators 
1.0 
2019/04/02 
Approval from chief investigator  
1.1 
2019/05/31 
Prepared for submission to the Committee for Clinical Research 
1.2 
2019/07/22 
Following review by the Committee for Clinical Research  
1.3 
2019/08/08 
Minor changes to affiliations, dataset and Gantt chart  
1.4 
2019/09/06 
Final CCR submission  
1.5 
2019/11/15 
RECUT+ Sub-study amendment 
1.6 
2020/01/14 
Following review by the Committee for Clinical Research 
1.7 
2020/04/16 
Removal of RECUT+ sub-study (moved to separate project) 
Provision for anonymised data submission 
1.8 
2021/07/29 
End of Study definition updated 
 

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CCR: CCR5156 
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2 PROPOSED CO-INVESTIGATORS 
 
First name, middle initial, 
surname 
Highest earned 
degree 
Department, section, institution, city and state or 
country 
Role 
Patrick Aidan 
MD 
Department of Otolaryngology - H&N Surgery 
American Hospital of Paris 
Paris, France 
Consultant 
Surender K Dabas 
MBBS MS DNB 
Department Head & Neck Surgery 
BL Kapur Super Specialist Hospital 
Delhi, India 
Consultant 
John R de Almeida 
MD, MSc 
Department of Otolaryngology - H&N Surgery 
University Health Network 
Toronto, ON, Canada 
Consultant 
Umamaheswar Duvvuri 
MD PhD 
Department of Otolaryngology  
Eye & Ear Institute, University of Pittsburgh 
Pittsburgh, PA, USA 
Consultant 
David Hamilton 
MBBS  
Department of Otolaryngology - H&N Surgery 
Newcastle upon Tyne Hospitals 
Newcastle, UK 
Consultant 
Tamer A Ghanem 
MD PhD 
Department of Otolaryngology - H&N Surgery 
Henry Ford Hospital 
Detroit, MI, USA 
Consultant 
Philippe Gorphe 
MD, MSc 
Head and Neck Oncology Department 
Institute Gustave Roussy  
Paris, France 
Consultant 
Neil D Gross 
MD 
Department of H&N Surgery 
MD Anderson Cancer Center 
Houston, TX, USA 
Consultant 
F Chris Holsinger 
MD 
Department of Otolaryngology - H&N Surgery 
Stanford University Medical Center 
Palo Alto, CA, USA 
Consultant 
J Scott Magnuson 
MD 
Department of Otolaryngology - H&N Surgery 
Florida Hospital Group 
Celebration, FL, USA 
Consultant 
Brett A Miles 
DDS, MD 
Department of Otolaryngology 
Mount Sinai Hospital 
New York City, NY, USA 
Consultant 
Eric J Moore 
MD 
Department of Otolaryngology - H&N Surgery 
Mayo Clinic 
Rochester, MN, USA 
Consultant 
Vinidh Paleri 
MBBS MS  
Head and Neck Unit 
The Royal Marsden Hospital 
London, UK 
Consultant 
Gouri Pantvaidya 
MBBS MS DNB 
Department of H&N Surgery 
Tata Memorial Hospital 
Mumbai, India 
Consultant 
Vincent Vander Poorten 
MD PhD 
Department of Otolaryngology - H&N Surgery 
University Hospitals Leuven 
Leuven, Belgium 
Consultant 
Niclas Rubek 
MD 
 
Department of Head and Neck Surgery 
Copenhagen University Hospital 
Copenhagen, Denmark 
Consultant 
Christian Simon 
MD 
Department of Otolaryngology - H&N Surgery 
Lausanne University Hospital 
Lausanne, Switzerland 
Consultant 
 

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CCR: CCR5156 
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First name, middle initial, 
surname 
Highest earned 
degree 
Department, section, institution, city and state or 
country 
Role 
John C Hardman 
MBChB MSc 
Head and Neck Unit 
The Royal Marsden Hospital 
London, UK 
Clinical 
Research 
Fellow 
Grainne Brady 
BSc MRes 
Head and Neck Unit 
The Royal Marsden Hospital 
London, UK 
Speech and 
language 
therapist 
Justin Roe 
BA(Hons) MSc 
PhD 
 
Head and Neck Unit 
The Royal Marsden Hospital 
London, UK 
Speech and 
language 
therapist 
Sarah Stephen 
BSc 
Department of Otolaryngology - H&N Surgery 
Newcastle upon Tyne Hospitals 
Newcastle, UK 
Speech and 
language 
therapist 

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CCR: CCR5156 
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3 PROJECT SUMMARY 
Rationale 
Recurrent head and neck cancer (HNC) is being increasingly been managed by surgical resection with good 
outcomes. The emerging role of transoral robotic surgery (TORS) has not been fully assessed in this context. 
Objectives 
Primary objective:  
To report disease-free survival at 2 years for patients with HNC recurrence treated with TORS. 
Secondary objectives: 
In patients with HNC recurrence treated with TORS: 
- 
To report overall and disease-specific survival at 2 years. 
- 
To report rates of close and involved surgical margins. 
- 
To report rates of gastrostomy and tracheostomy use at 1 year. 
Methods 
Retrospective observational cohort study from international centres. 
Timeframe 
Patients undergoing TORS for recurrence up to the July 31st 2018. 
Submission of data after July 31st 2020.  
Expected outcomes 
- 
Disease free survival rates of around 75% 2 years  
- 
High incidence of close surgical margins.  
- 
Low rates of tracheostomy and gastrostomy usage at 1 year.  

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CCR: CCR5156 
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4 SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to the 
principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written consent 
of the Sponsor 
I also confirm that I will make the findings of the study publicly available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent account 
of the study will be given; and that any discrepancies from the study as planned in this protocol will be 
explained. 
 
For and on behalf of the Study Sponsor: 
 
 
Print Name: 
 
 
 
Signature:  
  
 
 
Date:  
 
 
Chief Investigator: 
 
 
Print Name: 
Vinidh Paleri 
 
 
Signature:  
  
 
 
Date:  
 
 
 

The RECUT Study protocol v1.8 
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CCR: CCR5156 
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5 RATIONALE AND BACKGROUND INFORMATION 
 
Head and neck cancer (HNC) is the 6th most common type of cancer in the world and is increasing in 
incidence.[1,2] 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]).[3] 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.[4] 
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.[5] 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.[6] 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.[5] 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.[6–8] 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%.[6,9,10] 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. 

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CCR: CCR5156 
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6 AIM, OBJECTIVES AND OUTCOME MEASURES 
6.1 
Aim 
To establish the effectiveness of TORS in treating recurrent HNC. 
6.2 
Objectives 
Primary objective:  
To report disease-free survival at 2 years for patients with HNC recurrence treated with TORS. 
Secondary objectives: 
In patients with HNC recurrence treated with TORS: 
- 
To report overall and disease-specific survival at 2 years. 
- 
To report rates of close and involved surgical margins. 
- 
To report rates of gastrostomy and tracheostomy use at 1 year. 
6.3 
Outcome measures 
Primary outcome measure:  
Disease-free survival at 2 years. 
Secondary outcome measures: 
- 
Overall survival at 2 years. 
- 
Disease-specific survival at 2 years.  
- 
Rates of close and involved surgical margins. 
- 
Rate of gastrostomy use at 1 year. 
- 
Rate of tracheostomy use at 1 year. 

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CCR: CCR5156 
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7 STUDY DESIGN AND SETTING 
7.1 
Study design 
Retrospective cohort study 
7.2 
Study setting 
- 
Multicentre.  
- 
Tertiary referral units managing recurrent HNC. 
- 
International centres, who are active in the academic literature, and have performed at least 20 
primary TORS resections will be invited to be involved. 

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CCR: CCR5156 
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8 PARTICIPANT ELIGIBILITY CRITERIA 
8.1 
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.  
8.2 
Exclusion criteria 
- 
TORS used in a diagnostic setting only 
- 
Nasopharyngeal and thyroid cancers 

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CCR: CCR5156 
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9 STUDY PROCEDURES AND METHODOLOGY 
9.1 
Patient identification 
This will likely vary by centre. Some centres may keep a prospective log of all recurrent cancers and/or 
TORS cases. Other centres may have to re-screen their MDT or patient lists to identify patients. It is assumed 
that each centre contributing data will enter all consecutive eligible patients into the study.  
9.2 
Sampling timeframe 
Start date 
The start date of identification will vary by centre, relating to when the centre began performing TORS. 
There will be no restriction on the earliest date for a case to be eligible for submission. 
End date 
Surgery performed up until the July 31st 2018 inclusive.  
Submission of data will be requested after July 31st 2020 to allow 2 years minimum follow up from time of 
surgery.  
End of Study will be defined by resolution of all data queries and completion of database entries in 
preparation for final statistical analysis. Once this stage has been reached, a ‘Declaration of End of Study 
Form’ will be sent to RMH R&D and the Research Ethics Committee (REC) notifying them that the study is 
now concluded. A summary of the final research report will be provided to the Committee within 12 months 
of the conclusion of the study. This will report on whether the study achieved its objectives, summarise the 
main findings, and confirm arrangements for publication or dissemination of the research. 
9.3 
Consent 
Consent from individual patients will not be sought. This study will report on the outcomes of management 
that has already taken place. There will be no impact on the management of patients as a result of inclusion 
in the study.  
9.4 
Anonymisation of patients 
The project management team will not collect the names, addresses or medical record numbers (MRN) of 
any patients.  
Dates of birth, surgery recurrence, death and last follow up will be used to generate durations. Durations 
only, not dates, will be submitted to the project management team.  
Given the relative rarity of TORS for recurrent HNC, reporting and analysis will not identify individual cases 
in any subsequent reports, presentations and publications. 

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CCR: CCR5156 
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Pseudonymised data submission 
Where possible, centres will be asked to assign each case contributed with a local study ID. This will allow 
the project management team to query any incomplete or noncoherent data that is submitted with the 
local team. As there is traceability from the project management team’s database to a local study ID and 
then from that local study ID to a medical record number (MRN), this data would be considered 
pseudonymised.  
Anonymised data submission 
Where required, local teams may opt instead to submit fully anonymised data. In this instance, the local 
site will not keep a local study ID related to medical record number (MRN) and there will be no traceability 
from the project management team’s database to a local record. The submission of anonymised data will 
be reflected in the Data Sharing Agreement signed between the Data Discloser and the Data Receiver 
(RMH).  
The number of centres submitting pseudonymised and anonymised data will be reported. 
9.5 
Dataset 
The full dataset is available in an associated excel file. The dataset is divided into the following areas: 
1. General patient details: Demographics, smoking/alcohol and co-morbidities 
2. First cancer: Involved sites, staging, procedures and adjuvant treatment 
3. TORS for recurrence: Involved sites, staging, procedures, complications and adjuvant treatment 
4. Post-operative histology: Staging and margins 
5. Outcomes: Survival, recurrence, follow-up, diet/gastrostomy and tracheostomy status 
Co-morbidities 
The co-morbidity score will be taken using the Adult Co-morbidity Evaluation-27 (ACE-27) index, which is 
validated for use in HNC patients[11,12]. This rates the grade of decompensation affecting the various body 
systems, as well as presence of obesity and the status of any cancer or substance abuse. The grade of 
decompensation ranges between none (Grade 0) through mild, moderate and severe decompensation 
(Grades 1 to 3). The result is an Overall Comorbidity Score of 0 to 3, taken as the highest grade of 
decompensation in any one system/category, unless the patient scores grade 2 in two more different 
systems/categories, in which case they are designated Overall Score 3.  
Functional outcomes 
Functional outcome will be recorded using the ‘Normalcy of Diet’ rating from the Performance Status Scale 
for HNC patients (PSS-HN). This an 11 point scale giving a score between 0 and 100 ranging from complete 
gastrotomy tube dependence to an unrestricted diet.  
Gastrostomy tube use at 1 year will be recorded.  
Tracheostomy tube use at 1 year will be recorded.  

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CCR: CCR5156 
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Classification of ‘recurrent’ disease 
The following timeframes will be used to classify tumours treated after management of the original 
primary: 
- 
<12 months:   
 
Residual disease 
- 
12 months, <5 years:  
Recurrent disease 
- 
<5 years: 
 
 
New primary disease, separate site 
- 
5 years 
 
 
New primary disease 
9.6 
Data collection 
Data will be entered into an Excel spreadsheet with restricted data fields and data validation to improve 
data completeness and homogeneity. The Excel spreadsheet will be shared via secure email to observe 
appropriate data governance. The project management team will amalgamate databases from each centre 
for a pooled analysis.   
9.7 
Data storage 
John Hardman, the Clinical Research Fellow, will be the custodian of the data submitted to the Royal 
Marsden Hospital.  
Data will be stored on a named computer in the Head and Neck office at the sponsoring organisation, the 
Royal Marsden Hospital, Fulham Road, London, SW3 6JJ and held for 5 years. 
 
 

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CCR: CCR5156 
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10 STATISTICS AND DATA ANALYSIS 
10.1 Pooled analysis 
All cases will be entered into a pooled analysis. No individual centre will be identifiable from the analysis.  
10.2 Study end points 
Please see Outcome measures above. 
10.3 Sample size 
The final sample size will be dependent on the number of centres enrolled and the number of cases 
submitted by each centre. The expected number of patients recruited ranges between 50 to 150 patients. 
The table below shows the widths of the confidence intervals (95% CI) given a 75% DFS at 2 years. 
Table1 
Width of interval 
0.25 
0.17 
0.14 
DFS rate 
0.75 
0.75 
0.75 
95% CI 
0.63-0.88 
0.67-0.84 
0.68-0.82 
Number of patients needed 
47 
100 
147 
10.4 Data analysis 
Data analysis methods will include description of the participants at each centre for demographics, 
diagnosis and surgery using counts/number of patient and percentages for categorical data and 
mean/medium and standard deviation/range for continuous data.  
There is no control group for comparative analysis.  
Frequencies and percentages of all secondary endpoints will be reported. 95% confidence interval will be 
calculated where appropriate. 
Surgical margin will be used for subgroup analysis of survival. The disease-free survival at 2 years will be 
used to identify an optimal cut-off for the surgical margin in order to divide the cohort into two comparable 
groups. If sufficient data are available, a maximally selected rank statistic will be used to estimate the 
optimal cut off point for surgical margins. If insufficient data are available then the categorical variables will 
be positive margin, close margin (less than 3mm) and clear margin (≥3mm).  
The Clinical Research Fellow (JH) will be responsible for the database and analysis. Statistical support will 
be provided by the Research Data Management and Statistics Unit at The Royal Marsden NHS Foundation 
Trust. 
Statistical analysis will be conducted with Microsoft Excel, SPSS and R Studio software.[13–15] 
 
 

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CCR: CCR5156 
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10.5 Survival analysis 
Survival probability will be estimated with Kaplan Meier survival (KM) curves. Disease-free survival (DFS), 
overall survival (OS), and disease-specific survival (DSS), based on the pooled data, will be presented with 
95% prediction intervals.  
Survival will be measured from date of TORS procedure. Overall survival will be measured until date of 
death. Disease-free and disease-specific survival will be measured until residual disease, recurrent disease 
(locoregional or distant) or new primary disease is identified or has caused death respectively.  
The Cox proportional hazards regression model will be used to define the impact of prognostic factors on 
overall survival. Factors to be included in this model will include: Stage at recurrence (1/2 or 3/4, according 
to TNM 7), close or negative margin (as determined by the method below), co-morbidity score (nil/mild or 
moderate/severe), p16 status and timing of recurrence (residual disease or recurrent/second primary). 
Sub-group analyses 
Survival analysis will be presented separately for: SCCs and other histological types; for oropharyngeal SCCs 
(HPV positive and negative); and by tumour timing and location as set out in Classification of ‘recurrent’ 
disease. 
10.6 Censoring 
Patients will be censored in the survival analysis at the following time points: 
1. At their most recent follow up, if still under active surveillance, or  
2. At the point at which they were lost to follow up.  
We do not anticipate any events occurring that would require early withdrawal or further follow up 
impossible.  

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11 PROBLEMS ANTICIPATED 
11.1 Slow recruitment of centres 
Issue: 
Resistance to sharing data from individual centres for potential comparison with other international 
centres. 
Possible solutions: 
It is explicitly outlined that we will not be reporting outcomes from individual named centres. Our intention 
is not to see which centres are better or worse, as there may be large variation in case selection and 
treatment intent. Some centres are much more likely to offer palliative surgery and others may be more 
constrained by resources outside of the departments’ and/or surgeons’ control.  
11.2 Slow recruitment of patients 
Issue: 
Busy centres may be willing to contribute data but may not be able to dedicate clinician time to collect the 
primary data in a reasonable time frame 
Possible solutions: 
The Gannt chart outlines the project timeline to guide progress. We will use international meeting 
deadlines to help dictate deadlines and keep momentum in the project.  

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CCR: CCR5156 
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12 ETHICAL CONSIDERATIONS 
12.1 Ethical review 
The study was reviewed and approved by the Health Resource Authority on 5th November 2019 IRAS 
268830. It is assumed that centres submitting cases will have secured the necessary local approvals for 
their locality.  
12.2 Patient contacts 
No additional patient contacts are required as part of this study.  
12.3 Patient consent 
As this is a retrospective cohort study, no explicit consent for involvement will have been sought from the 
included cases. In the majority of cases, the treating surgeon will not be the researcher. Data to be analysed 
will be submitted by the treating surgeon to the researchers on the project management team.  In order 
to maintain patient confidentiality, no patient identifiable data will be transmitted to the researchers.  
12.4 Potential identification of patients 
Please see Anonymisation of patients above. 

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CCR: CCR5156 
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13 PROJECT MANAGEMENT TEAM 
 
Name 
John Hardman 
Role(s) 
Co-investigator 
Clinical research fellow 
First author 
Responsibilities 
Design of dataset and analysis strategy. 
Data analysis. 
Drafting of manuscript(s). 
Submission of manuscript(s). 
 
 
 
 
Name 
Vinidh Paleri 
Role(s) 
Chief investigator 
Senior author 
Responsibilities 
Oversight of project design, conduct, analysis and reporting.  
Liaison with ethics committees and other review bodies, as appropriate. 
Final review of drafted manuscript(s). 
Publication strategy. 
 
This study will contribute towards the pursuit of a Doctorate at the Institute for Cancer Research by John 
Hardman, the Clinical Research Fellow. Some of the data collected from this study may be used in the 
relevant thesis, prior to ultimate submission for publication or presentation.  

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14 AUTHORSHIP POLICY 
14.1 Criteria for inclusion in authorship 
All contributing centres will be included in any subsequent presentations and publications. All contributing 
authors will have: 
- 
Contributed to the acquisition of data, and 
- 
Contributed to the revising of any manuscripts, and  
- 
Given final approval of the submitted manuscripts, and 
- 
Agreed to be accountable for the integrity of the work. 
This is in accordance to the International Committee of Medical Journal Editors guidance for contributing 
authors.[16] 
Each site may have a lead contributor and associated contributors included, as long as criteria above are 
satisfied.  
14.2 Acknowledgements 
All individuals contributing to the data collection will be acknowledged in any subsequent presentations 
and publications.  

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CCR: CCR5156 
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15 FUNDING 
Salary for the Clinical Research Fellow is provided by a grant from the Oracle Cancer Trust and the Royal 
College of Surgeons of England and ENT UK.  
 

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CCR: CCR5156 
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16 TABLE OF ACRONYMS 
 
Acronym 
Meaning 
ACE-27 
Adult Co-morbidity Evaluation-27 
ASA 
American Society of Anesthesiologists 
AWD 
Alive with disease 
CCR 
Committee for Clinical Research (Royal Marsden Hospital) 
CT 
Computed tomography 
DFS 
Disease-free survival 
DOC 
Died of other causes 
DOD 
Died of disease 
DSS 
Disease-specific survival 
H&N 
Head and neck 
HNC 
Head and neck cancer 
HPV 
Human papilloma virus 
HRA 
Health Research Authority 
IRAS 
Integrated Research Application System 
IRB 
Institutional review board 
KM 
Kaplan Meier 
MDADI 
M. D. Anderson Dysphagia Inventory 
MDT 
Multidisciplinary team 
MRI 
Magnetic resonance imaging 
MRN 
Medical record number 
NED 
No evidence of disease 
OS 
Overall survival 
PET CT 
Positron emission tomography and computed tomography 
PSS-HN 
Performance status scale for head and neck cancer patients 
RMH 
Royal Marsden Hospital 
ROC 
Receiving operating characteristic curve 
SCC 
Squamous cell carcinoma 
SIR 
Standardised incidence ratio 
TORS 
Transoral robotic surgery 
 

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CCR: CCR5156 
Page 23 
17 REFERENCES 
 
1.  Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 
2011;61(2):69–90.  
2.  Shield KD, Ferlay J, Jemal A, Sankaranarayanan R, Chaturvedi AK, Bray F, et al. The global incidence of 
lip, oral cavity, and pharyngeal cancers by subsite in 2012. CA Cancer J Clin 2017;67(1):51–64.  
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The RECUT Study protocol v1.8 
29th July 2021 
IRAS: 268830  
CCR: CCR5156 
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