Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
- Conditions
- Cancer Head Neck
- Interventions
- Genetic: Molecular AnalysisOther: Radiomic/ Morphological analysis
- Registration Number
- NCT05933889
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exploratory molecular analysis 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. Radiology/ radiomic analysis Radiomic/ Morphological 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.
- Primary Outcome Measures
Name Time Method To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy 2 years To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
- Secondary Outcome Measures
Name Time Method To report rates of 30-day post-operative haemorrhage 30 days To report rates of 30-day post-operative haemorrhage
To report rates of 30-day major haemorrhage necessitating surgical intervention 30 days To report rates of 30-day major haemorrhage necessitating surgical intervention
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy 2 years Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
To report rates of 30-day post-operative mortality 30 days To report rates of 30-day post-operative mortality
To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy 12 months To report the rate of feeding tube use at 12 months post-operatively
To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy 12 months To report the rate of tracheostomy tube use at 12 months post-operatively
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis 2 years Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. 2 years To report 2-year overall 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 To report 2-year disease specific 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-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Trial Locations
- Locations (1)
The Royal Marsden Hospital NHS Foundation Trust
🇬🇧London, United Kingdom