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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Molecular Analyses
GeneticNucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples collected.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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
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
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.