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Trial Title:
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or ReCurrent SqUamous CEll Carcinoma of the Head and Neck
NCT ID:
NCT05808920
Condition:
Head and Neck Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Genetic
Intervention name:
Molecular Analyses
Description:
Nucleic acid extraction, protein analysis. Tumour tissue, blood and saliva samples
collected.
Arm group label:
Group 1
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Head and Neck Unit, Royal Marsden Hospital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Andrew Williamson
Email:
andrew.williamson2@rmh.nhs.uk
Start date:
September 8, 2023
Completion date:
August 1, 2028
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05808920
