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

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

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

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.

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.