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

Royal Marsden NHS Foundation Trust

Status: Enrolling

Conditions: Cancer Head Neck

Treatments: Other: Radiomic/ Morphological analysis; Genetic: Molecular Analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05933889

CCR5852 (Other Identifier)

IRAS327707 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 3 patient groups

Retrospective observational cohort

Description:

Retrospective patients undergoing transoral robotic surgery for early stage T1-2 oropharyngeal cancers on or before to 31/12/2021. Data will be collected from medical records.

Exploratory molecular analysis

Description:

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.

Treatment:

Genetic: Molecular Analysis

Radiology/ radiomic analysis

Description:

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.

Treatment:

Other: Radiomic/ Morphological analysis