Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence (STORM)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：John Hardman, MBChB
- 电话号码：442073528171
- 邮箱：johncharles.hardman@nhs.net
研究联系人备份
- 姓名：Amy O'Reilly
- 电话号码：020 8661 3567
- 邮箱：amy.o'reilly@rmh.nhs.uk
学习地点
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London、英国、SW3 6JJ
- 招聘中
- The Royal Marsden Hospital
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接触：
- Vinidh Paleri, MS FRCS
- 电话号码：0207 808 2732
- 邮箱：Vinidh.Paleri@rmh.nhs.uk
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接触：
- John Hardman, MBChB
- 邮箱：John.Hardman@rmh.nhs.uk
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首席研究员：
- Vinidh Paleri, MS FRCS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Local recurrence-free survival time
大体时间：At 2 years
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At 2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Overall survival time
大体时间：At 2 and 5 years
|
At 2 and 5 years
|
|
Disease-specific survival time
大体时间：At 2 and 5 years
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At 2 and 5 years
|
|
Disease-free survival time
大体时间：At 2 and 5 years
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At 2 and 5 years
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|
Post-operative haemorrhage time
大体时间：Within 30 days
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Within 30 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.