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

Head and Neck Cancer Clinical Trial

— RESCUE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808920
• Other study ID #: CCR 5752
• Status: Recruiting
• Start date: September 8, 2023
• Est. completion date: August 1, 2028

Study information

• Verified date: May 2024
• Source: Royal Marsden NHS Foundation Trust
• Contact: Andrew Williamson
• Phone: 02073528171
• Email: andrew.williamson2[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged over 18

2. Previous H&N SCC treated with radiotherapy with or without chemotherapy

3. Local or regionally recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx

4. Ability to give informed consent for biological sample collection (molecular analysis study only)

Exclusion Criteria:

1. Nasopharyngeal and cutaneous SCC of the H&N

2. Thyroid, salivary gland, and non-squamous cell H&N cancers

3. Presence of distant metastasis (M1) or surgically inoperable T4b tumours

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Genetic:
• Molecular Analyses
Nucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected.

Locations

Country	Name	City	State
United Kingdom	Head and Neck Unit, Royal Marsden Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascertain the 2-year disease-free survival post salvage surgery	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)	Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
Secondary	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	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.
Secondary	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	Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
Secondary	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.	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.
Secondary	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.	University of Washing Quality of life questionnaire distributed pre-operatively, 6 months and 12 months.
Secondary	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.	MD Anderson Dysphagia Inventory distributed pre-operatively, 6 months and 12 months.
Secondary	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	Through study completion, expected duration of 3 years
Secondary	Determine the impact of close and involved margins on overall survival outcomes	Determine the impact of close and involved margins on overall survival outcomes	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	Ascertain how the extent of salvage neck dissection influences overall survival outcomes.	Ascertain how the extent of salvage neck dissection influences overall survival outcomes.	Through study completion, expected duration of 3 years
Secondary	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.	Through study completion, expected duration of 3 years
Secondary	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.	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	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	Through study completion, expected duration of 3 years
Secondary	Using multi-variate analysis, establish the clinical prognostic indicators 12 month tracheostomy and gastrostomy dependence.	Establish the clinical prognostic indicators of functional outcomes	Through study completion, expected duration of 3 years
Secondary	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.	Through study completion, expected duration of 3 years