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

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

NCT ID: NCT05933889

Condition: Cancer Head Neck

Conditions: Official terms:
Oropharyngeal Neoplasms
Head and Neck Neoplasms

Conditions: Keywords:
Robotic Surgical Procedures
Margins of Excision
Oropharyngeal neoplasms
Local neoplasm recurrence
Recurrence free survival

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Genetic
Intervention name: Molecular Analysis
Description: Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Arm group label: Exploratory molecular analysis

Intervention type: Other
Intervention name: Radiomic/ Morphological analysis
Description: Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Arm group label: Radiology/ radiomic analysis

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.

Criteria for eligibility:

Study pop:
Patients aged 18 years and older diagnosed with early (T1-T2) primary oropharyngeal squamous cell carcinoma, treated with transoral robotic surgery with or without adjuvant therapy.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Royal Marsden Hospital NHS Foundation Trust

Address:
City: London
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Andrew Williamson
Email: RESCUE@rmh.nhs.uk

Start date: December 19, 2023

Completion date: August 2027

Lead sponsor:
Agency: Royal Marsden NHS Foundation Trust
Agency class: Other

Source: Royal Marsden NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05933889