The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck

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.

• Define the 2- and 5-year overall and disease specific survival in retrospectively identified patients [Time frame: 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.]
• Define the 2 year overall and disease specific survival in prospectively identified patients [Time frame: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.]
• Report on gross functional outcomes by documenting rates of gastrostomy and tracheostomy dependence at 1-year post-salvage surgery. [Time frame: 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.]
• For the prospective cohort assess the overall quality-of-life outcomes pre-operatively and at 6- and 12-months post-surgery using validated questionnaires. [Time frame: University of Washing Quality of life questionnaire distributed pre-operatively, 6 months and 12 months.]
• 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. [Time frame: MD Anderson Dysphagia Inventory distributed pre-operatively, 6 months and 12 months.]
• Estimate the rates of close and involved surgical margins across all surgical salvage procedures [Time frame: Through study completion, expected duration of 3 years]
• Determine the impact of close and involved margins on overall survival outcomes [Time frame: Through study completion, expected duration of 3 years]
• Determine the impact of close and involved margins on disease-free survival outcomes [Time frame: Through study completion, expected duration of 3 years]
• Determine the impact of close and involved margins on disease-specific survival outcomes [Time frame: 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 [Time frame: Through study completion, expected duration of 3 years]
• Ascertain how the extent of salvage neck dissection influences overall survival outcomes. [Time frame: Through study completion, expected duration of 3 years]
• Ascertain how the extent of salvage neck dissection influences disease-free survival outcomes. [Time frame: Through study completion, expected duration of 3 years]