- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04673929
Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract (RECUT)
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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London, Storbritannia, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital NHS Foundation Trust
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Greater London
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London, Greater London, Storbritannia, SW3 6JJ
- Rekruttering
- Head and Neck Unit, Royal Marsden Hospital
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Ta kontakt med:
- John Hardman
- Telefonnummer: 442073528171
- E-post: johncharles.hardman@nhs.net
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Ta kontakt med:
- Marta Vergnano
- E-post: marta.vergnano@rmh.nhs.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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patients with HNC recurrence treated with TORS
Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Disease-free survival at 2 years
Tidsramme: 24 months
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Disease-free survival at 2 years
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24 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Overall survival at 2 years
Tidsramme: 24 months
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Overall survival at 2 years
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24 months
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Disease-specific survival at 2 years
Tidsramme: 24 months
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Disease-specific survival at 2 years
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24 months
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Rate of gastrostomy use at 1 year
Tidsramme: 12 months
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Rate of gastrostomy use at 1 year
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12 months
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Rate of tracheostomy use at 1 year
Tidsramme: 12 months
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Rate of tracheostomy use at 1 year
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12 months
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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].
- 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.
- Piccirillo JF. Importance of comorbidity in head and neck cancer. Laryngoscope. 2000 Apr;110(4):593-602. doi: 10.1097/00005537-200004000-00011.
- 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.
- 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/
- 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
- Hardman JC, Holsinger FC, Brady GC, Beharry A, Bonifer AT, D'Andrea G, Dabas SK, de Almeida JR, Duvvuri U, Floros P, Ghanem TA, Gorphe P, Gross ND, Hamilton D, Kurukulasuriya C, Larsen MHH, Lin DJ, Magnuson JS, Meulemans J, Miles BA, Moore EJ, Pantvaidya G, Roof S, Rubek N, Simon C, Subash A, Topf MC, Van Abel KM, Vander Poorten V, Walgama ES, Greenlay E, Potts L, Balaji A, Starmer HM, Stephen S, Roe J, Harrington K, Paleri V. Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study. J Natl Cancer Inst. 2022 Oct 6;114(10):1400-1409. doi: 10.1093/jnci/djac130.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
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