Clinical trial NCT05808920: The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Official title: The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Aged over 18
2. Previous H\&N SCC treated with radiotherapy with or without chemotherapy
3. Local or regionally recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx
4. Ability to give informed consent for biological sample collection (molecular analysis study only)

Exclusion Criteria:

1. Nasopharyngeal and cutaneous SCC of the H\&N
2. Thyroid, salivary gland, and non-squamous cell H\&N cancers
3. Presence of distant metastasis (M1) or surgically inoperable T4b tumours

Primary outcomes:
measure: Ascertain the 2-year disease-free survival post salvage surgery
timeFrame: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
Secondary outcomes:
measure: Define the 2- and 5-year overall and disease specific survival in retrospectively identified patients
timeFrame: 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.
measure: Define the 2 year overall and disease specific survival in prospectively identified patients
timeFrame: Study duration is 3 years to include 1 year recruitment period. Active follow-up for patients is up to 2 years.
measure: Report on gross functional outcomes by documenting rates of gastrostomy and tracheostomy dependence at 1-year post-salvage surgery.
timeFrame: 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.
measure: For the prospective cohort assess the overall quality-of-life outcomes pre-operatively and at 6- and 12-months post-surgery using validated questionnaires.
timeFrame: University of Washing Quality of life questionnaire distributed pre-operatively, 6 months and 12 months.
measure: 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.
timeFrame: MD Anderson Dysphagia Inventory distributed pre-operatively, 6 months and 12 months.
measure: Estimate the rates of close and involved surgical margins across all surgical salvage procedures
timeFrame: Through study completion, expected duration of 3 years
measure: Determine the impact of close and involved margins on overall survival outcomes
timeFrame: Through study completion, expected duration of 3 years
measure: Determine the impact of close and involved margins on disease-free survival outcomes
timeFrame: Through study completion, expected duration of 3 years
measure: Determine the impact of close and involved margins on disease-specific survival outcomes
timeFrame: Through study completion, expected duration of 3 years
measure: Establish the rates of super-selective, selective and modified/ radical salvage neck dissection in clinically N0 and N+ necks
timeFrame: Through study completion, expected duration of 3 years
measure: Ascertain how the extent of salvage neck dissection influences overall survival outcomes.
timeFrame: Through study completion, expected duration of 3 years
measure: Ascertain how the extent of salvage neck dissection influences disease-free survival outcomes.
timeFrame: Through study completion, expected duration of 3 years
measure: Ascertain how the extent of salvage neck dissection influences disease-specific survival outcomes.
timeFrame: Through study completion, expected duration of 3 years
measure: Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease
timeFrame: Through study completion, expected duration of 3 years
measure: Describe the impact of neck dissection on overall survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease
timeFrame: Through study completion, expected duration of 3 years
measure: Describe the impact of neck dissection on disease-free survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease
timeFrame: Through study completion, expected duration of 3 years
measure: Describe the impact of neck dissection on disease-specific survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease
timeFrame: Through study completion, expected duration of 3 years
measure: Using multi-variate analysis, establish the clinical prognostic indicators of overall, disease free and disease specific survival.
timeFrame: Through study completion, expected duration of 3 years
measure: Using multi-variate analysis, establish the clinical prognostic indicators 12 month tracheostomy and gastrostomy dependence.
timeFrame: Through study completion, expected duration of 3 years
measure: 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.
timeFrame: Through study completion, expected duration of 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Head and Neck Unit, Royal Marsden Hospital
Study officials:
affiliation: Royal Marsden Hospital NHS Foundation Trust
name: Vinidh Paleri
role: PRINCIPAL_INVESTIGATOR
References: