The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- Ascertain the 2-year disease-free survival post salvage surgery
研究概览
简要总结
The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC).
Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.
详细描述
The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC).
Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.
The aim of this study is to determine the survival, functional and quality of life outcomes of patients undergoing all salvage surgery for recurrent, residual and new primary head and neck SCC, and to establish the genetic architecture and clonal evolution H&N SCC after previous treatment for radiotherapy cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Aged over 18
- •Previous H&N SCC treated with radiotherapy with or without chemotherapy
- •Local or regionally recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx
- •Ability to give informed consent for biological sample collection (molecular analysis study only)
排除标准
- •Nasopharyngeal and cutaneous SCC of the H&N
- •Thyroid, salivary gland, and non-squamous cell H&N cancers
- •Presence of distant metastasis (M1) or surgically inoperable T4b tumours
研究组 & 干预措施
Group 1
Participants with previous diagnosis of H&N SCC treated with radiotherapy. Recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx treated with salvage surgery
干预措施: Molecular Analyses (Genetic)
结局指标
主要结局
Ascertain the 2-year disease-free survival post salvage surgery
时间窗: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
Ascertain the 2-year disease-free survival post salvage surgery for recurrent/ residual/ new primary head and neck SCC (split cohort of prospective and retrospective patients)
次要结局
- Describe the impact of neck dissection on disease-free survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease(Through study completion, expected duration of 3 years)
- Define the 2 year overall and disease specific survival in prospectively identified patients(Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.)
- For the prospective cohort assess the swallow-related quality-of-life outcomes at pre-operatively and at 6- and 12-months post-surgery using validated questionnaires.(MD Anderson Dysphagia Inventory distributed pre-operatively, 6 months and 12 months.)
- Determine the impact of close and involved margins on overall survival outcomes(Through study completion, expected duration of 3 years)
- Ascertain how the extent of salvage neck dissection influences overall survival outcomes.(Through study completion, expected duration of 3 years)
- For the prospective cohort assess the overall quality-of-life outcomes pre-operatively and at 6- and 12-months post-surgery using validated questionnaires.(University of Washing Quality of life questionnaire distributed pre-operatively, 6 months and 12 months.)
- Estimate the rates of close and involved surgical margins across all surgical salvage procedures(Through study completion, expected duration of 3 years)
- Determine the impact of close and involved margins on disease-free survival outcomes(Through study completion, expected duration of 3 years)
- Determine the impact of close and involved margins on disease-specific survival outcomes(Through study completion, expected duration of 3 years)
- Establish the rates of super-selective, selective and modified/ radical salvage neck dissection in clinically N0 and N+ necks(Through study completion, expected duration of 3 years)
- Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease(Through study completion, expected duration of 3 years)
- Describe the impact of neck dissection on overall survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease(Through study completion, expected duration of 3 years)
- Compare the DNA genetic and epigenetic changes in residual, recurrent, and new primary head and neck squamous cell carcinoma with primary tumour and germline DNA samples.(Through study completion, expected duration of 3 years)
- Define the 2- and 5-year overall and disease specific survival in retrospectively identified patients(Study duration is 3 years to include 1 year recruitment period. Active follow-up for prospective patients is up to 2 years. Follow-up for retrospective patients is up to 5 years.)
- Report on gross functional outcomes by documenting rates of gastrostomy and tracheostomy dependence at 1-year post-salvage surgery.(Study duration is 3 years with up to 2 years follow-up in prospective and up to 5 years follow-up in retrospective patients. Functional outcomes will be measured from the date of surgery.)
- Using multi-variate analysis, establish the clinical prognostic indicators of overall, disease free and disease specific survival.(Through study completion, expected duration of 3 years)
- Using multi-variate analysis, establish the clinical prognostic indicators 12 month tracheostomy and gastrostomy dependence.(Through study completion, expected duration of 3 years)
- Ascertain how the extent of salvage neck dissection influences disease-free survival outcomes.(Through study completion, expected duration of 3 years)
- Ascertain how the extent of salvage neck dissection influences disease-specific survival outcomes.(Through study completion, expected duration of 3 years)
- Describe the impact of neck dissection on disease-specific survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease(Through study completion, expected duration of 3 years)