Cancer Head Neck Clinical Trial
— SCOREOfficial 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
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
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
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 |
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