The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
- Conditions
- Head and Neck Cancer
- Interventions
- Genetic: Molecular Analyses
- Registration Number
- NCT05808920
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Molecular Analyses 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
- Primary Outcome Measures
Name Time Method Ascertain the 2-year disease-free survival post salvage surgery 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)
- Secondary Outcome Measures
Name Time Method 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 Describe the impact of neck dissection on disease-free survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease
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. 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
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. 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.
Determine the impact of close and involved margins on overall survival outcomes Through study completion, expected duration of 3 years Determine the impact of close and involved margins on overall survival outcomes
Ascertain how the extent of salvage neck dissection influences overall survival outcomes. Through study completion, expected duration of 3 years Ascertain how the extent of salvage neck dissection influences overall survival outcomes.
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. 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.
Estimate the rates of close and involved surgical margins across all surgical salvage procedures Through study completion, expected duration of 3 years Estimate the rates of close and involved surgical margins across all surgical salvage procedures
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-free survival outcomes
Determine the impact of close and involved margins on disease-specific survival outcomes Through study completion, expected duration of 3 years Determine the impact of close and involved margins on disease-specific survival outcomes
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 Establish the rates of super-selective, selective and modified/ radical salvage neck dissection in clinically N0 and N+ necks
Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease Through study completion, expected duration of 3 years Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease
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 Describe the impact of neck dissection on overall survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease
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 Assess the molecular makeup of head and neck tumours that have not responded to radiotherapy treatment, or which recur having previously responded.
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. 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
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. Report on gross functional outcomes by documenting rates of gastrostomy and tracheostomy dependence at 1-year post-salvage 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 Establish the clinical prognostic indicators of positive survival and functional outcomes
Using multi-variate analysis, establish the clinical prognostic indicators 12 month tracheostomy and gastrostomy dependence. Through study completion, expected duration of 3 years Establish the clinical prognostic indicators of functional outcomes
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-free survival outcomes.
Ascertain how the extent of salvage neck dissection influences disease-specific survival outcomes. Through study completion, expected duration of 3 years Ascertain how the extent of salvage neck dissection influences disease-specific survival outcomes.
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 Describe the impact of neck dissection on disease-specific survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease
Trial Locations
- Locations (1)
Head and Neck Unit, Royal Marsden Hospital
🇬🇧London, United Kingdom