Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Recurrent Head and Neck Cancer Clinical Trial

— RECUT  

Official title:

Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673929
• Other study ID #: CCR5156
• Status: Recruiting
• Start date: February 14, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Recurrence
• Recurrent Head and Neck Cancer

Locations

Country	Name	City	State
United Kingdom	Head and Neck Unit, Royal Marsden Hospital	London	Greater London
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (16)

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. — View Citation

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. — View Citation

Gross ND, Hanna EY. The Role of Surgery in the Management of Recurrent Oropharyngeal Cancer. Recent Results Cancer Res. 2017;206:197-205. Review. — View Citation

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. Review. — View Citation

ICMJE | Recommendations | Defining the Role of Authors and Contributors [Internet]. [cited 2019 Jan 23];Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

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 Unpublished

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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

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

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. — View Citation

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. — View Citation

Piccirillo JF. Importance of comorbidity in head and neck cancer. Laryngoscope. 2000 Apr;110(4):593-602. — View Citation

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/

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. — View Citation

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. — View Citation

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. Erratum in: JAMA Otolaryngol Head Neck Surg.n 2013 Dec;139(12):1290. Sweeny, Larissa [added]. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival at 2 years	Disease-free survival at 2 years	24 months
Secondary	Overall survival at 2 years	Overall survival at 2 years	24 months
Secondary	Disease-specific survival at 2 years	Disease-specific survival at 2 years	24 months
Secondary	Rate of gastrostomy use at 1 year	Rate of gastrostomy use at 1 year	12 months
Secondary	Rate of tracheostomy use at 1 year	Rate of tracheostomy use at 1 year	12 months