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临床试验/NCT04673929
NCT04673929已完成不适用

Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Royal Marsden NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2020年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
278
试验地点
2
主要终点
Disease-free Survival at 2 Years

研究概览

简要总结

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

详细描述

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and is increasing in incidence. Squamous cell carcinomas (SCC) account for the majority of these HNCs. An increasing number of these SCCs are being found to be associated with the Human Papilloma Virus (HPV) which has also been shown to be associated with a more favourable outcome. These HPV related cancers tend to affect younger patients with fewer comorbidities. As such, we are finding a larger cohort of patients are surviving for longer after treatment for their primary cancers.

HNC patients are over 11 times more likely to experience a second head and neck primary cancer than the general population over 20 years of follow up (SIR 11.2, 95% CI [10.6-11.8]). In addition to second primaries, patients may suffer from residual disease after treatment for their initial primary, identified within a 12 month period, or recurrent disease, cancer at the same site identified within 5 years. Treatment for all of these cancers, which we will broadly term 'recurrent' cancers for the purposes of this study, can be complex. Commonly, radiotherapy will have formed part of the treatment regime at either the primary site or to the neck for these patients. Radiotherapy causes fibrosis in the irradiated tissues, reducing tissue pliability, contributing to trismus and reducing healing potential at the effected sites. This can pose significant challenges to any further surgical intervention, which may form the mainstay of any subsequent management if re-irradiation is not an option or not indicated. Surgery must then look to be as minimally invasive as possible in order to maximise functional outcomes and reduce disruption of affected tissues.

Options for surgery have traditionally involved transmandibular and transcervical routes. More recently transoral routes have been adopted as endoscopic instruments become more widely available and adopted. Transoral Robotic Surgery (TORS) is the latest development in the field which confers some significant advantages to the surgeon and to the patient. For the surgeon, the endoscopic view is binocular, giving a close objective lens and excellent depth perception. Further, the instruments have wrists which sit within the body cavity, allowing manipulation of the tissues beyond the direct line of sight through the oral stoma. For the patient, there is less disrupted tissue if access incisions are avoided, reducing the volume of tissue that would be susceptible to scarring which can affect swallowing function or lead to fistula formation.

However, there are little data to show oncological and functional outcomes are acceptable following TORS surgery for recurrent cancers. This is in part as it is a relatively new technology and in part because whilst increasingly common, the absolute number of surgeries performed remains relatively low at individual centres. Published outcomes have shown 2 year disease-free survival rates around 75%. The RECUT study aims to use a collaborative methodology to document the outcomes from TORS for recurrent HNC being performed at a number of high volume centres across the globe.

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

入选标准

  • Aged over 18
  • Previous Head & Neck Cancer treated with radiotherapy
  • Undergoing Transoral Robotic Surgery as part of their management for recurrent disease
  • Surgery performed on or before July 31st 2018.

排除标准

  • Transoral Robotic Surgery used in a diagnostic setting only
  • Nasopharyngeal and thyroid cancers

结局指标

主要结局

Disease-free Survival at 2 Years

时间窗: 24 months

Disease-free survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

Disease-specific Survival at 2 Years

时间窗: 24 months

Disease-specific survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

次要结局

  • Overall Survival at 2 Years(24 months)
  • Rate of Gastrostomy Use at 1 Year(12 months)
  • Rate of Tracheostomy Use at 1 Year(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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