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Recurrent Head and Neck CancerRECUTNCT04673929

Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

An observational study of Recurrent Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Head and Neck Cancer
How many people
278 participants
Where
2 sitesUnited Kingdom
Study dates
14 Feb 2020to 1 Oct 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Transoral Robotic Surgery used in a diagnostic setting only
  • Nasopharyngeal and thyroid cancers

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Head and Neck Unit, Royal Marsden Hospital

    London, Greater London, SW3 6JJ

  • Royal Marsden Hospital NHS Foundation Trust

    London, SW3 6JJ

Other trials in United Kingdom

About this study

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

Read the 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.

Keywords
Recurrent head and neck cancer, transoral robotic surgery, TORS, HNC recurrence
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04673929
Study groupRoleWhat they receive
patients with Head & Neck Cancer recurrence treated with Transoral Robotic SurgeryReport of disease-free survival at 2 years for patients with Head \& Neck Cancer recurrence treated with Transoral Robotic Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

  2. 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

    Measured: 24 months

Secondary outcomes (3)

  1. 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

    Measured: 24 months

  2. Rate of Gastrostomy Use at 1 Year

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

    Measured: 12 months

  3. Rate of Tracheostomy Use at 1 Year

    Rate of tracheostomy use at 1 year

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start14 Feb 2020
  3. Primary completion1 Oct 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673929
Sponsor's protocol ID
CCR5156
Acronym
RECUT
Status last verified
Nov 2024
First submitted
9 Dec 2020
Last updated
9 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Shield KD, Ferlay J, Jemal A, Sankaranarayanan R, Chaturvedi AK, Bray F, Soerjomataram I. The global incidence of lip, oral cavity, and pharyngeal cancers by subsite in 2012. CA Cancer J Clin. 2017 Jan;67(1):51-64. doi: 10.3322/caac.21384. Epub 2016 Oct 19.

    PubMed 28076666

  • INTEGRATE (The National ENT Trainee Research Network). British Association of Head and Neck Oncologists Surveillance audit 2018. Unpublished

  • Chuang SC, Scelo G, Tonita JM, Tamaro S, Jonasson JG, Kliewer EV, Hemminki K, Weiderpass E, Pukkala E, Tracey E, Friis S, Pompe-Kirn V, Brewster DH, Martos C, Chia KS, Boffetta P, Brennan P, Hashibe M. Risk of second primary cancer among patients with head and neck cancers: A pooled analysis of 13 cancer registries. Int J Cancer. 2008 Nov 15;123(10):2390-6. doi: 10.1002/ijc.23798.

    PubMed 18729183

  • Gross ND, Hanna EY. The Role of Surgery in the Management of Recurrent Oropharyngeal Cancer. Recent Results Cancer Res. 2017;206:197-205. doi: 10.1007/978-3-319-43580-0_15.

    PubMed 27699540

  • Paleri V, Fox H, Coward S, Ragbir M, McQueen A, Ahmed O, Meikle D, Saleh D, O'Hara J, Robinson M. Transoral robotic surgery for residual and recurrent oropharyngeal cancers: Exploratory study of surgical innovation using the IDEAL framework for early-phase surgical studies. Head Neck. 2018 Mar;40(3):512-525. doi: 10.1002/hed.25032. Epub 2017 Dec 15.

    PubMed 29244229

  • Hamilton D, Paleri V. Role of transoral robotic surgery in current head & neck practice. Surgeon. 2017 Jun;15(3):147-154. doi: 10.1016/j.surge.2016.09.004. Epub 2016 Oct 11.

    PubMed 27742406

  • Weinstein GS, O'Malley BW Jr, Cohen MA, Quon H. Transoral robotic surgery for advanced oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Nov;136(11):1079-85. doi: 10.1001/archoto.2010.191.

    PubMed 21079160

  • White H, Ford S, Bush B, Holsinger FC, Moore E, Ghanem T, Carroll W, Rosenthal E, Sweeny L, Magnuson JS. Salvage surgery for recurrent cancers of the oropharynx: comparing TORS with standard open surgical approaches. JAMA Otolaryngol Head Neck Surg. 2013 Aug 1;139(8):773-8. doi: 10.1001/jamaoto.2013.3866.

    PubMed 23949352

  • Dabas S, Dewan A, Ranjan R, Dewan AK, Shukla H, Sinha R. Salvage Transoral Robotic Surgery for Recurrent or Residual Head and Neck Squamous Cell Carcinoma: A Single Institution Experience. Asian Pac J Cancer Prev. 2015;16(17):7627-32. doi: 10.7314/apjcp.2015.16.17.7627.

    PubMed 26625773

  • Piccirillo JF. Importance of comorbidity in head and neck cancer. Laryngoscope. 2000 Apr;110(4):593-602. doi: 10.1097/00005537-200004000-00011.

    PubMed 10764003

  • Paleri V, Wight RG. Applicability of the adult comorbidity evaluation - 27 and the Charlson indexes to assess comorbidity by notes extraction in a cohort of United Kingdom patients with head and neck cancer: a retrospective study. J Laryngol Otol. 2002 Mar;116(3):200-5. doi: 10.1258/0022215021910528.

    PubMed 11893262

  • Microsoft. Excel for Mac [Internet]. Redmond, Washington, USA: Microsoft Corporation; 2018. Available from: https://products.office.com/

  • R Core Team. R: A language and environment for statistical computing [Internet]. Vienna, Austria: R Foundation for Statistical Computing; 2013. Available from: http://www.R-project.org/

  • RStudio Team. RStudio: Integrated Development Environment for R [Internet]. Boston, MA: RStudio, Inc.; 2015. Available from: http://www.rstudio.com/

Questions about this trial

What is this clinical trial studying?

An observational study of Recurrent Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival at 2 Years (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673929, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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