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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer Head Neck
• Intervention / Treatment: Genetic: Molecular Analysis; Other: Radiomic/ Morphological analysis

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Andrew Williamson; Phone Number: 02000000000; Email: andrew.williamson2@rmh.nhs.uk
• Study Contact Backup: Name: Reyhaneh Sadegh Zadeh; Phone Number: 02000000000; Email: reyhaneh.sadeghzadeh@rmh.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • The Royal Marsden Hospital NHS Foundation Trust
    • Contact: Andrew Williamson; Email: RESCUE@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiology/ radiomic 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.	Other: Radiomic/ Morphological analysis; Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Retrospective observational cohort; 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; 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.	Genetic: Molecular Analysis; Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples

What is the study measuring?

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 rates of 30-day post-operative mortality	To report rates of 30-day post-operative mortality	30 days
To report rates of 30-day post-operative haemorrhage	To report rates of 30-day post-operative haemorrhage	30 days
To report rates of 30-day major haemorrhage necessitating surgical intervention	To report rates of 30-day major haemorrhage necessitating surgical intervention	30 days
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 12 months post-operatively	12 months
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 12 months post-operatively	12 months
Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis	Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.	Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.	2 years
Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.	Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.	2 years
Correlation of high-risk radiomic/ or morphological features and local recurrence	Correlation of high-risk radiomic/ or morphological features and local recurrence	2 years
Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.	Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.	2 years
Correlation of high-risk genetic features with 2 year local recurrence outcomes	Correlation of high-risk genetic features with 2 year local recurrence outcomes	2 years

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Vinidh Paleri, Royal Marsden Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• Hardman JC, Holsinger FC, Brady GC, Beharry A, Bonifer AT, D'Andrea G, Dabas SK, de Almeida JR, Duvvuri U, Floros P, Ghanem TA, Gorphe P, Gross ND, Hamilton D, Kurukulasuriya C, Larsen MHH, Lin DJ, Magnuson JS, Meulemans J, Miles BA, Moore EJ, Pantvaidya G, Roof S, Rubek N, Simon C, Subash A, Topf MC, Van Abel KM, Vander Poorten V, Walgama ES, Greenlay E, Potts L, Balaji A, Starmer HM, Stephen S, Roe J, Harrington K, Paleri V. Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study. J Natl Cancer Inst. 2022 Oct 6;114(10):1400-1409. doi: 10.1093/jnci/djac130.
• Warner L, O'Hara JT, Lin DJ, Oozeer N, Fox H, Meikle D, Hamilton D, Iqbal MS, Robinson M, Paleri V. Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. Oral Oncol. 2022 Jul;130:105909. doi: 10.1016/j.oraloncology.2022.105909. Epub 2022 May 26.
• Williamson A, Moen CM, Slim MAM, Warner L, O'Leary B, Paleri V. Transoral robotic surgery without adjuvant therapy: A systematic review and meta-analysis of the association between surgical margins and local recurrence. Oral Oncol. 2023 Dec;147:106610. doi: 10.1016/j.oraloncology.2023.106610. Epub 2023 Nov 9.

Helpful Links

• IReC twitter handle

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Robotic Surgical Procedures; Local neoplasm recurrence; Margins of Excision; Oropharyngeal neoplasms; Recurrence free survival
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Head and Neck Neoplasms; Oropharyngeal Neoplasms
• Other Study ID Numbers: CCR5852 (Other Identifier: Royal Marsden Committee for Clinical Research); IRAS327707 (Other Identifier: UK NHS HRA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No