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

Study Overview
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Brief Summary
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Retrospective multicentre observational cohort study with optional exploratory radiomic study (international) and molecular analysis studies (UK only).

Detailed Description
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The SCORE study is a retrospective 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. Additionally, the SCORE study will contain an exploratory molecular analysis of consenting patients to help further define OPSCC molecular characteristics in those who experience recurrence and those who do not. Finally, the SCORE study will 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.

Official Title
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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

Conditions
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Cancer Head Neck

Intervention / Treatment
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* Genetic: Molecular Analysis
* Other: Radiomic/ Morphological analysis


Participation Criteria
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Eligibility Criteria
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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 1st September 2021 For the exploratory analysis only: ● Ability to consent to molecular analysis study 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective observational cohort<br>Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 01/09/2021. Data will be collected from medical records. | Genetic: Molecular Analysis<br>* Germline analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples<br>Other: Radiomic/ Morphological analysis<br>* Radiomic analysis and assessment of morphological features of pre-operative imaging in patients who have undergone TORS for primary oropharyngeal cancer.<br>|
| Exploratory molecular analysis<br>Retrospective patients based in the UK identified from the retrospective analysis 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. | Genetic: Molecular Analysis<br>* Germline analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples<br>|
| Radiology/ radiomic analysis<br>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. | Other: Radiomic/ Morphological analysis<br>* Radiomic analysis and assessment of morphological features of pre-operative imaging in patients who have undergone TORS for primary oropharyngeal cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy | To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | 2 years | 
| To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | 2 years | 
| To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | 2 years | 
| Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy | Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy | 2 years | 
| To report 30-day peri-operative mortality | To report 30-day peri-operative mortality | 30 days | 
| To report rates of post-operative haemorrhage | To report rates of post-operative haemorrhage | 2 years | 
| To report rates major haemorrhage necessitating surgical intervention | To report rates major haemorrhage necessitating surgical intervention | 2 years | 
| To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy | To report the rate of feeding tube use at 6, 12, and 24 months post-operatively | 2 years | 
| To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy | To report the rate of tracheostomy tube use at 6, 12, and 24 months post-operatively | 2 years | 
| Identify clinical and pathological factors predictive of 2-year locoregional recurrence free survival on uni- and multivariate analysis | Identify clinical and pathological factors predictive of 2-year locoregional recurrence free survival on uni- and multivariate analysis | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Surgical Procedures, Margins of Excision, Oropharyngeal neoplasms, Local neoplasm recurrence, Recurrence free survival