PEARL: PET-BASED ADAPTIVE RADIOTHERAPY CLINICAL TRIAL
Research type
Research Study
Full title
PEARL: A Phase 1 trial of PET-based adaptive radiotherapy in patients undergoing radical chemoradiotherapy for Human Papilloma Virus (HPV)-positive oropharyngeal cancer.
IRAS ID
242633
Contact name
Mererid Evans
Contact email
Sponsor organisation
Velindre University NHS Trust
Clinicaltrials.gov Identifier
2495, Funder reference (Cancer Research Wales)
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Oropharyngeal cancer (OPSCC) caused by Human Papillomavirus (HPV) infection is increasing in incidence in the UK. It tends to affect younger patients and has a better outcome than many other head and neck cancers.
A large proportion of patients diagnosed with HPV positive OPSCC will be recommended non-surgical techniques as their primary treatment. The non-surgical treatment usually involves 6 weeks of radiotherapy with chemotherapy given weekly or during the first and fourth week (CCRT) of the radiotherapy course. We know that HPV positive OPSCC responds better to radiotherapy than HPV negative OPSCC. Because of their favourable prognosis, many patients are cured of their disease but often have to live for several decades with any side effects of their treatment. Though every effort is made to minimise these, side effects can be permanent and have a significant impact on the patient’s quality of life. Side effects from radiotherapy are usually due to a proportion of normal tissue receiving radiation. The way we plan and deliver radiotherapy is improving all the time and there are currently a variety of alterations being researched to try to further reduce the severity of side effects without reducing the success of any treatment.
The PEARL study will recruit approximately 50 patients who are recommended primary treatment with CCRT from South Wales (Velindre Cancer Centre and Swansea) and Bristol over 2 years. The main aim is to see whether it is feasible to perform a PET-CT after 2 weeks of radiotherapy and re-plan the radiotherapy based on this PET scan so that a smaller area of the throat is getting the high dose. This could potentially lead to reduced side effects from the treatment, and an improved quality of life in the long term. The re-planning of the radiotherapy will be done whilst the patient is having their third week of radiotherapy and so there won’t be any delay or gap in the treatment course.
Patients recruited to PEARL will be asked for permission to collect several blood and saliva samples before, during and after treatment. We will be looking at the scans and blood tests taken during the trial to see if any component helps us predict who will respond best to treatment. This is important as additional treatments can sometimes be necessary in order to give the patient the best possible chance of cure in the long term.REC name
Wales REC 2
REC reference
18/WA/0391
Date of REC Opinion
7 Dec 2018
REC opinion
Further Information Favourable Opinion