Head and Neck CancerRESCUENCT05808920
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
An observational study of Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 9 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Molecular Analyses
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 8 Sep 2023to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United Kingdom9 sites, 8 recruiting
- Recruiting
University Hospitals Derby and Burton
Derby
Sean Mortimore, 0000, uhdb.radiotherapytrials@nhs.net
- Recruiting
NHS Lothian
Edinburgh
Iain Nixon, 0000, iain.nixon@nhs.scot
- Recruiting
Western General, Greater Glasgow and Clyde
Glasgow
Catriona Douglas, 0000, catriona.douglas@ggc.scot.nhs.uk
- Recruiting
Aintree Hospital
Liverpool
Terry Jones, 00000, terry.jones@liverpoolft.nhs.uk
- Recruiting
Head and Neck Unit, Royal Marsden Hospital
London, SW3 6JJ
Vishak Muraleedharan Shylaja, vishak.muraleedharanshylaja@rmh.nhs.uk
- Recruiting
Northwick Park
London
Swati Chhabra, 0000, swati.chhabra@nhs.net
- Recruiting
Oxford University Hospital NHS Foundation Trust
Oxford
Stuart Winter, 0000, stuart.winter@ouh.nhs.uk
- Recruiting
Poole Hospital, University Hospitals Dorset
Poole
Emma King, 0000, emma.king@uhd.nhs.uk
- Completed
South Tyneside and Sunderland NHS Foundation Trust
Sunderland
About this study
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Molecular Analyses
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular AnalysesGenetic
Nucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Molecular Analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
Secondary outcomes (20)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Through study completion, expected duration of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start8 Sep 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinidh Paleri, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808920
- Sponsor's protocol ID
- CCR 5752
- Acronym
- RESCUE
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT05808920
- Acronym / sponsor ID
- RESCUE / CCR 5752
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: Molecular AnalysesParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular AnalysesNucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected. | Genetic | Group 1 |
Primary outcome
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)
20 secondary outcomes
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 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.
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.
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.
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
Time frame: 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 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
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
Time frame: 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 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.
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
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
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
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
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.
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.
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.
Time frame: Through study completion, expected duration of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinidh Paleri principal investigator
Royal Marsden Hospital NHS Foundation Trust
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Williamson (02073528171 ext. 1876, andrew.williamson2@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.