Actively Recruiting
Head and Neck Early Relapse Detection Study (HERD)
Led by University College, London · Updated on 2023-10-05
200
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone. More than 60% of cases are diagnosed at the locally advanced stage. These patients are treated with radical intent, using a combination of surgery, radiotherapy and/or chemotherapy. Unfortunately 5 in 10 patients relapse within 2 years, with most relapses occurring within the first year since treatment. Unlike many other solid tumours, 80% of relapses occur locoregionally. Salvage surgery offers the best chance of long-term survival for patients with loco-regional recurrence, but this is only possible if the recurrence is amenable to resection. Salvage surgery has been estimated to improve survival outcomes in relapsed cancer by up to 73%. For salvage surgery to be feasible, relapses need to be detected early. Current surveillance strategies have little evidence base, with imaging often driven by clinical symptoms - often when the recurrence is no longer amenable to salvage surgery. With this study, we will address the unmet clinical need to develop a risk-stratified surveillance pathway to enhance detection of early relapse of radically treated head and neck cancer. At present, tumour grade and biomarkers such as HPV status have offered important but insufficient information to guide surveillance strategies.
CONDITIONS
Official Title
Head and Neck Early Relapse Detection Study (HERD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, locally advanced HPV negative head and neck squamous cell carcinoma considered intermediate or high risk
- Offered radical treatment including surgery and/or postoperative adjuvant/consolidation treatment or radical chemo-radiation
- Age 18 years or older
- Adequate bone marrow function with neutrophils, platelets, and hemoglobin grade 0 or 1 according to CTCAE
You will not qualify if you...
- HPV positive disease
- Presence of another active cancer
- Confirmed distant metastatic disease on recent imaging
- Known Hepatitis B, C, or HIV infection
- Contraindications to MRI such as cardiac pacemaker, metallic implants, or major claustrophobia
- Pregnant or lactating patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guy's and St Thomas'
London, United Kingdom
Actively Recruiting
Research Team
T
Trial Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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