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

NCT05808920 | Recruiting

• 1 other identifier: CCR 5752
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 9

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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 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.

• 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.

  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.

  MD Anderson Dysphagia Inventory distributed pre-operatively, 6 months and 12 months.

Study Arms (1)

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

Interventions

Molecular Analyses GENETIC

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (9)

University Hospitals Derby and Burton

Derby, United Kingdom

RECRUITING

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Western General, Greater Glasgow and Clyde

Glasgow, United Kingdom

RECRUITING

Aintree Hospital

Liverpool, United Kingdom

RECRUITING

Head and Neck Unit, Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

Northwick Park

London, United Kingdom

RECRUITING

Oxford University Hospital NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

Poole Hospital, University Hospitals Dorset

Poole, United Kingdom

RECRUITING

South Tyneside and Sunderland NHS Foundation Trust

Sunderland, United Kingdom

COMPLETED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and tumour tissue samples will be collected for analysis as per the protocol.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Molecular Docking Simulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Models, Molecular; Models, Theoretical; Investigative Techniques

Study Officials

• Vinidh Paleri

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Williamson

CONTACT

02073528171; andrew.williamson2@rmh.nhs.uk

Sarah Burton

CONTACT

02073528171; RESCUE@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: April 12, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)