Clinical trial NCT05933889: Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Head Neck
Keywords: Robotic Surgical Procedures
Margins of Excision
Oropharyngeal neoplasms
Local neoplasm recurrence
Recurrence free survival
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
timeFrame: 2 years
Secondary outcomes:
measure: To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
timeFrame: 2 years
measure: To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
timeFrame: 2 years
measure: To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
timeFrame: 2 years
measure: Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
timeFrame: 2 years
measure: To report rates of 30-day post-operative mortality
timeFrame: 30 days
measure: To report rates of 30-day post-operative haemorrhage
timeFrame: 30 days
measure: To report rates of 30-day major haemorrhage necessitating surgical intervention
timeFrame: 30 days
measure: To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy
timeFrame: 12 months
measure: To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy
timeFrame: 12 months
measure: Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis
timeFrame: 2 years
Other outcomes:
measure: Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.
timeFrame: 2 years
measure: Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.
timeFrame: 2 years
measure: Correlation of high-risk genetic features with 2 year local recurrence outcomes
timeFrame: 2 years
measure: Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.
timeFrame: 2 years
measure: Correlation of high-risk radiomic/ or morphological features and local recurrence
timeFrame: 2 years
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden Hospital NHS Foundation Trust
Study officials:
affiliation: Royal Marsden Hospital NHS Foundation Trust
name: Vinidh Paleri
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.