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

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ClinicalTrials.gov Identifier: NCT05808920

Recruitment Status : Recruiting

First Posted : April 12, 2023

Last Update Posted : May 8, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Royal Marsden NHS Foundation Trust

Tracking Information

First Submitted Date

February 8, 2023

First Posted Date

April 12, 2023

Last Update Posted Date

May 8, 2024

Actual Study Start Date

September 8, 2023

Estimated Primary Completion Date

August 1, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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)

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

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
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
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.
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.
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.
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
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
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
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
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
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.
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.
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.
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
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
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
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
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
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
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.

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

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 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.

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Other

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

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

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.

Condition

Head and Neck Cancer

Intervention

Genetic: Molecular Analyses

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

Study Groups/Cohorts

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

Intervention: Genetic: Molecular Analyses

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

400

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

August 1, 2028

Estimated Primary Completion Date

August 1, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact: Andrew Williamson	02073528171 ext 1876	andrew.williamson2@rmh.nhs.uk
Contact: Jeane Guevara	02073528171 ext 1876	RESCUE@rmh.nhs.uk

Listed Location Countries

United Kingdom

Removed Location Countries

Administrative Information

NCT Number

NCT05808920

Other Study ID Numbers

CCR 5752

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

Royal Marsden NHS Foundation Trust

Original Responsible Party

Same as current

Current Study Sponsor

Royal Marsden NHS Foundation Trust

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

Vinidh Paleri

Royal Marsden Hospital NHS Foundation Trust

PRS Account

Royal Marsden NHS Foundation Trust

Verification Date

May 2024

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