Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

NCT04673929 | Completed Results

• 1 other identifier: CCR5156
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 2

Brief Summary

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

Conditions

Recurrent Head and Neck Cancer

Keywords

Recurrent head and neck cancer; transoral robotic surgery; TORS; HNC recurrence

Outcome Measures

Primary Outcomes (2)

• 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

  24 months

• 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

  24 months

Secondary Outcomes (3)

• Overall Survival at 2 Years

  24 months

• Rate of Gastrostomy Use at 1 Year

  12 months

• Rate of Tracheostomy Use at 1 Year

  12 months

Study Arms (1)

patients with Head & Neck Cancer recurrence treated with Transoral Robotic Surgery

Report of disease-free survival at 2 years for patients with Head \& Neck Cancer recurrence treated with Transoral Robotic Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (2)

Head and Neck Unit, Royal Marsden Hospital

London, Greater London, SW3 6JJ, United Kingdom

Location

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Related Publications (17)

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  BACKGROUND

• 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.

  PMID: 35944904 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Professor Vinidh Paleri
• Organization: The Royal Marsden Hospital

vinidh.paleri@rmh.nhs.uk

02078082732

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: February 14, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-11

Locations

GB (2)