Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
NCT ID: NCT05933889
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2023-12-19
2027-08-31
Brief Summary
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Detailed Description
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Retrospective SCORE patients will optionally contain an exploratory radiomic and radiology morphological analysis to ascertain high risk features of positive margins and local recurrence following TORS for early oropharyngeal cancer.
Additionally, the SCORE study will contain a prospective exploratory molecular analysis of consenting patients to help further define OPSCC molecular characteristics in those who experience recurrence and those who do not, in addition to assessing levels of circulating tumour DNA in before and after TORS procedures.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Retrospective observational cohort
Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 31/12/2021. Data will be collected from medical records.
No interventions assigned to this group
Exploratory molecular analysis
Consenting prospective patients based in the UK identified will be invited to participate in the exploratory molecular analysis by their usual care team. If agreeable, patients will consent to donation of either blood or buccal swab samples, in addition to archival tissue from their primary, and if relevant, recurrent tissue samples.
Molecular Analysis
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Radiology/ radiomic analysis
Retrospective patients based in the UK and abroad will have their pre-operative imaging transferred to the RMH radiology department which will undergo radiomic and morphological assessment to ascertain features that put patients at high risk of local recurrence and positive margins.
Radiomic/ Morphological analysis
Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Interventions
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Molecular Analysis
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Radiomic/ Morphological analysis
Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Eligibility Criteria
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Inclusion Criteria
* Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior oropharyngeal walls)
* Histologically confirmed squamous cell carcinoma.
* P16 positive or negative tumours
* Index cancer treated with TORS with or without adjuvant therapy.
* Early pT1-T2 stage oropharyngeal SCC
* TORS performed on or before 31st December 2021
For the exploratory analysis only:
* Ability to consent to molecular analysis study
* Ability to consent to radiomic/ imaging study (as required for international centres)
Exclusion Criteria
* TORS performed for diagnostic, recurrent, or palliative intentions.
* Prior history of head and neck cancer or radiation therapy at any time
* Known distant metastatic disease.
* Nasopharyngeal, thyroid, cutaneous, and non-SCC head and neck cancers.
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Vinidh Paleri
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden Hospital NHS Foundation Trust
Locations
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The Royal Marsden Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Warner L, O'Hara JT, Lin DJ, Oozeer N, Fox H, Meikle D, Hamilton D, Iqbal MS, Robinson M, Paleri V. Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. Oral Oncol. 2022 Jul;130:105909. doi: 10.1016/j.oraloncology.2022.105909. Epub 2022 May 26.
Williamson A, Moen CM, Slim MAM, Warner L, O'Leary B, Paleri V. Transoral robotic surgery without adjuvant therapy: A systematic review and meta-analysis of the association between surgical margins and local recurrence. Oral Oncol. 2023 Dec;147:106610. doi: 10.1016/j.oraloncology.2023.106610. Epub 2023 Nov 9.
Other Identifiers
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CCR5852
Identifier Type: OTHER
Identifier Source: secondary_id
IRAS327707
Identifier Type: OTHER
Identifier Source: secondary_id
CCR5852
Identifier Type: -
Identifier Source: org_study_id
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