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

February 9, 2026 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Derby, United Kingdom
      • Edinburgh, United Kingdom
      • Glasgow, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom, SW3 6JJ
      • London, United Kingdom
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospital NHS Foundation Trust
        • Contact:
      • Poole, United Kingdom
        • Recruiting
        • Poole Hospital, University Hospitals Dorset
        • Contact:
      • Sunderland, United Kingdom
        • Completed
        • South Tyneside and Sunderland NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with recurrent, residual or new primary head and neck SCC following previous treatment with radiotherapy with or without chemotherapy who have undergone or will undergo salvage surgical resection of their cancer. Head and neck subsites including the oropharynx, oral cavity, larynx and hypopharynx will be included. H&N SCC of nasopharyngeal and cutaneous origins, non-SCC, thyroid and salivary gland tumours of the head and neck will be excluded.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
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
Genetic: Molecular Analyses
Nucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ascertain the 2-year disease-free survival post salvage surgery
Time Frame: 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)
Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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- 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.
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.
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.
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.
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.
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 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.
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.
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.
Estimate the rates of close and involved surgical margins across all surgical salvage procedures
Time Frame: Through study completion, expected duration of 3 years
Estimate the rates of close and involved surgical margins across all surgical salvage procedures
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 overall survival outcomes
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-free survival outcomes
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
Determine the impact of close and involved margins on disease-specific survival outcomes
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
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
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 overall survival outcomes.
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
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-specific 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.
Through study completion, expected duration of 3 years
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
Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent 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
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
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
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
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
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
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.
Time Frame: Through study completion, expected duration of 3 years
Establish the clinical prognostic indicators of positive survival and functional outcomes
Through study completion, expected duration of 3 years
Using multi-variate analysis, establish the clinical prognostic indicators 12 month tracheostomy and gastrostomy dependence.
Time Frame: Through study completion, expected duration of 3 years
Establish the clinical prognostic indicators of functional outcomes
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.
Time Frame: 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.
Through study completion, expected duration of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Vinidh Paleri, Royal Marsden Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR 5752

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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