Clinical trial · Observational
Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
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
NCT05933889CI-TRIAL-00079591SCORErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Head Neck | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular Analysis | Genetic | — | UNRESOLVED |
| Radiomic/ Morphological analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Retrospective observational cohort
- description
- 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.
- label
- Exploratory molecular analysis
- description
- 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.
- interventionNames
- Genetic: Molecular Analysis
- label
- Radiology/ radiomic analysis
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDHardman 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
- BACKGROUNDWarner 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
- BACKGROUNDWilliamson 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