Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer

Официальное название

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

Обзор

Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).

Подробное описание

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.

Вмешательства

• Генная терапия Molecular Analysis
  Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
• Другое 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.

Первичные конечные точки

• To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy [Срок оценки: 2 years]

Вторичные конечные точки (10)

• To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. [Срок оценки: 2 years]
• To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. [Срок оценки: 2 years]
• To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. [Срок оценки: 2 years]
• Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy [Срок оценки: 2 years]
• To report rates of 30-day post-operative mortality [Срок оценки: 30 days]
• To report rates of 30-day post-operative haemorrhage [Срок оценки: 30 days]
• To report rates of 30-day major haemorrhage necessitating surgical intervention [Срок оценки: 30 days]
• To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy [Срок оценки: 12 months]
• To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy [Срок оценки: 12 months]
• Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• The Royal Marsden Hospital NHS Foundation Trust — London

Публикации

• 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

Идентификаторы

NCT: NCT05933889 · CCR5852 · CCR5852 · IRAS327707

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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