Cancer Head Neck
Conditions
Keywords
Robotic Surgical Procedures, Margins of Excision, Oropharyngeal neoplasms, Local neoplasm recurrence, Recurrence free survival
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.
Interventions
GENETICMolecular Analysis
Germline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
OTHERRadiomic/ 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.
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy | 2 years | To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy | 2 years | Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy |
| To report rates of 30-day post-operative haemorrhage | 30 days | To report rates of 30-day post-operative haemorrhage |
| To report rates of 30-day major haemorrhage necessitating surgical intervention | 30 days | To report rates of 30-day major haemorrhage necessitating surgical intervention |
| To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy | 12 months | To report the rate of feeding tube use at 12 months post-operatively |
| To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy | 12 months | To report the rate of tracheostomy tube use at 12 months post-operatively |
| Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis | 2 years | Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis |
| To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. | 2 years | To report 2-year overall 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 | To report 2-year disease-free 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 | To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy. |
| To report rates of 30-day post-operative mortality | 30 days | To report rates of 30-day post-operative mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of high-risk genetic features with 2 year local recurrence outcomes | 2 years | Correlation of high-risk genetic features with 2 year local recurrence outcomes |
| Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence. | 2 years | Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence. |
| Correlation of high-risk radiomic/ or morphological features and local recurrence | 2 years | Correlation of high-risk radiomic/ or morphological features and local recurrence |
| Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer. | 2 years | Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer. |
| Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not. | 2 years | Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not. |
Countries
United Kingdom
Contacts
Primary ContactAndrew Williamson
Backup ContactReyhaneh Sadegh Zadeh
Outcome results
None listed