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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05808920

Acronym

RESCUE

Enrollment

400

Registered

2023-04-12

Start date

2023-09-08

Completion date

2029-04-30

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief summary

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.

Interventions

GENETICMolecular Analyses

Nucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United Kingdom

Contacts

CONTACTAndrew Williamson

andrew.williamson2@rmh.nhs.uk02073528171

CONTACTSarah Burton

RESCUE@rmh.nhs.uk02073528171

PRINCIPAL_INVESTIGATORVinidh Paleri

Royal Marsden Hospital NHS Foundation Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026

Measure	Time frame	Description
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
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
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.
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.
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.
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 overall survival outcomes	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 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
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.
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.
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
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
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
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
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.