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

Cancer Head Neck Clinical Trial

— SCORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933889
• Other study ID #: CCR5852
• Secondary ID: CCR5852IRAS32770
• Status: Recruiting
• Start date: December 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Royal Marsden NHS Foundation Trust
• Contact: Andrew Williamson
• Phone: 02000000000
• Email: andrew.williamson2[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Head Neck
• Head and Neck Neoplasms
• Oropharyngeal Neoplasms

Intervention

Genetic:
• Molecular Analysis
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples

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.

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Correlation of high-risk radiomic/ or morphological features and local recurrence	Correlation of high-risk radiomic/ or morphological features and local recurrence	2 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To report rates of 30-day post-operative mortality	To report rates of 30-day post-operative mortality	30 days
Secondary	To report rates of 30-day post-operative haemorrhage	To report rates of 30-day post-operative haemorrhage	30 days
Secondary	To report rates of 30-day major haemorrhage necessitating surgical intervention	To report rates of 30-day major haemorrhage necessitating surgical intervention	30 days
Secondary	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
Secondary	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
Secondary	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