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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
研究概览
简要总结
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
时间窗: 2 years
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
次要结局
- 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)
- To report long term feeding tube use after primary TORS surgery with and without post-operative radiotherapy(12 months)
- To report long term tracheostomy tube use after primary TORS surgery with and without post-operative radiotherapy(12 months)
- Identify clinical and pathological factors predictive of 2-year survival outcomes on uni- and multivariate analysis(2 years)
- To report 2-year overall 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)
- To report rates of 30-day post-operative haemorrhage(30 days)
- To report rates of 30-day major haemorrhage necessitating surgical intervention(30 days)
- To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.(2 years)