Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Local recurrence-free survival time
研究概览
简要总结
Retrospective observational cohort study investigating Single modality Trans Oral Robotic surgery for primary oropharyngeal cancer: exploring the impact of surgical Margins on local disease recurrence.
详细描述
The STORM study will examine transoral surgery performed before 31st July 2019. STORM is a retrospective observational cohort study, involving international centres performing TORS for primary OPSCC.
The main aim of this study is to explore the impact of surgical margins on local disease recurrence in primary oropharyngeal squamous cell carci-noma treated with transoral robotic surgery (TORS) without adjuvant therapy.
The primary objective is to report local recurrence-free survival. The primary endpoint will be Local recurrence-free survival time.
The secondary objectives are to report overall survival, disease-specific survival and disease-free survival, and to report post-operative haemor-rhage rates. The secondary endpoints include Overall survival time, Dis-ease-specific survival time, Disease-free survival time, Post-operative haemorrhage time.
Exploratory objective to identify a clinically relevant cut-off for surgical margins as a predictor of local disease recurrence.
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 OPSCC.
- •Index cancer treated with TORS without adjuvant therapy.
- •Any post-operative TNM classification.
- •TORS performed on or before 31st July 2019.
排除标准
- •TORS preformed for diagnostic or palliative intentions.
- •Known distant metastasis at time of TORS.
- •Nasopharyngeal and thyroid cancers.
- •Patients undergoing neoadjuvant or adjuvant chemotherapy, biotherapy, immunotherapy or radiotherapy to either the neck or primary site.
结局指标
主要结局
Local recurrence-free survival time
时间窗: At 2 years
次要结局
- Overall survival time(At 2 and 5 years)
- Disease-specific survival time(At 2 and 5 years)
- Disease-free survival time(At 2 and 5 years)
- Post-operative haemorrhage time(Within 30 days)