The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or ReCurrent SqUamous CEll Carcinoma of the Head and Neck

Royal Marsden NHS Foundation Trust

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Genetic: Molecular Analyses

Study type: Observational

Funder types: Other

Identifiers

NCT05808920

CCR 5752

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Group 1

Description:

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

Treatment:

Genetic: Molecular Analyses