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

NCT05933889 | Recruiting

• 2 other identifiers: CCR5852IRAS327707
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Head Neck

Keywords

Robotic Surgical Procedures; Margins of Excision; Oropharyngeal neoplasms; Local neoplasm recurrence; Recurrence free survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

  2 years

• 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

  2 years

• To report rates of 30-day post-operative mortality

  30 days

Other Outcomes (5)

• Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.

  2 years

• 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

  2 years

Study Arms (3)

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

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

Interventions

Molecular Analysis GENETIC

Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples

Exploratory molecular analysis

Radiomic/ Morphological analysis OTHER

Radiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.

Radiology/ radiomic analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Related 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.

  PMID: 35944904 BACKGROUND

• 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.

  PMID: 35636080 BACKGROUND

• 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.

  PMID: 37951118 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples to be collected for germline and circulating tumour DNA analysis: * Blood * Buccal swabs Samples to be taken as part of standard care for molecular analysis: \- Fresh or Archival Tumour tissue (biopsies and resections)

MeSH Terms

Conditions

Head and Neck Neoplasms; Margins of Excision; Oropharyngeal Neoplasms; Neoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Pathologic Processes

Study Officials

• Vinidh Paleri

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Williamson

CONTACT

02000000000; andrew.williamson2@rmh.nhs.uk

Reyhaneh Sadegh Zadeh

CONTACT

02000000000; reyhaneh.sadeghzadeh@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 6, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

GB (1)