Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Molecular Analysis, Radiomic/ Morphological analysis.
- Who it may be relevant to
- Registry conditions: Cancer Head Neck. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence: The SCORE Study
Overview
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Detailed description
The SCORE study is a international multicentre cohort study investigating the local recurrence free survival outcomes in patients undergoing transoral robotic surgery with and without adjuvant therapy for early stage (T1-T2) oropharyngeal squamous cell carcinoma (OPSCC). Important secondary objectives include assessment of other survival measures (overall, disease free and disease specific), determination of a safe margin "cut off" that minimises the risk of local recurrence, and reporting the rate of early post-operative complications and mortality.
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.
Interventions
- Genetic Molecular Analysis
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples - Other 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.
Primary outcome measures
- To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy [Time frame: 2 years]
Secondary outcome measures (10)
- To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. [Time frame: 2 years]
- To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. [Time frame: 2 years]
- To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. [Time frame: 2 years]
- Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy [Time frame: 2 years]
- To report rates of 30-day post-operative mortality [Time frame: 30 days]
- To report rates of 30-day post-operative haemorrhage [Time frame: 30 days]
- To report rates of 30-day major haemorrhage necessitating surgical intervention [Time frame: 30 days]
- To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy [Time frame: 12 months]
- To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy [Time frame: 12 months]
- Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 18 years and older.
- 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
- Moderate to advanced stage T3-T4 oropharyngeal SCC
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- The Royal Marsden Hospital NHS Foundation Trust — London
Publications
- 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, PMID 35944904
- 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. PMID 35636080
- 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. PMID 37951118
Identifiers
NCT: NCT05933889 · CCR5852 · CCR5852 · IRAS327707