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

Define the 2- and 5-year overall and disease specific survival in retrospectively identified patients

Define the 2- and 5-year overall and disease specific survival in retrospectively identified patients undergoing salvage surgery for recurrent/ residual/ new primary head and neck SCC

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

Define the 2 year overall and disease specific survival in prospectively identified patients undergoing salvage surgery for recurrent/ residual/ new primary head and neck SCC

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.

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.

For the prospective cohort assess the overall quality-of-life outcomes at pre-operatively and at 6- and 12-months post-surgery using validated University of Washington Quality of Life questionnaire.

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.

For the prospective cohort assess the swallow-related quality-of-life outcomes 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

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

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

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

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

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.

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.

Ascertain how the extent of salvage neck dissection influences disease-free survival outcomes.

Time frame: Through study completion, expected duration of 3 years

Ascertain how the extent of salvage neck dissection influences disease-specific survival outcomes.

Ascertain how the extent of salvage neck dissection influences disease-specific survival outcomes.

Time frame: Through study completion, expected duration of 3 years

Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease

Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease

Time frame: 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

Describe the impact of neck dissection on overall survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease

Time frame: Through study completion, expected duration of 3 years

Describe the impact of neck dissection on disease-free survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease

Describe the impact of neck dissection on disease-free survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease

Time frame: 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

Describe the impact of neck dissection on disease-specific survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease

Time frame: Through study completion, expected duration of 3 years

Using multi-variate analysis, establish the clinical prognostic indicators of overall, disease free and disease specific survival.

Establish the clinical prognostic indicators of positive survival and functional outcomes

Time frame: Through study completion, expected duration of 3 years

Using multi-variate analysis, establish the clinical prognostic indicators 12 month tracheostomy and gastrostomy dependence.

Establish the clinical prognostic indicators of functional outcomes

Time frame: 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.

Assess the molecular makeup of head and neck tumours that have not responded to radiotherapy treatment, or which recur having previously responded.

Time frame: Through study completion, expected duration of 3 years