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NCT Number: NCT05808920

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

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.

Recruiting

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Derby and Burton, Derby, United Kingdom

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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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Molecular analyses

Genetic

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Williamson

CONTACT

[email protected]

02073528171 ext. 1876

Sarah Burton

CONTACT

[email protected]

02073528171 ext. 1876

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Acronym: RESCUE

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Apr 12, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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