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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Molecular Analyses

    Genetic

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Group 11 intervention

Trial outcomes

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)

Time frame
Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.

Secondary outcomes

1

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

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.
2

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

Time frame
Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
3

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.

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.
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.

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.

Time frame
University of Washing Quality of life questionnaire distributed pre-operatively, 6 months and 12 months.

Other outcomes

Sponsors and contacts

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