Oropharyngeal Cancer Clinical Trial
Official title:
PEARL: PET-based Adaptive Radiotherapy Clinical Trial
The PEARL study will recruit approximately 50 patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) who are about to undergo primary treatment with concurrent chemo-radiation from South Wales (Velindre Cancer Centre and Singleton Hospital, Swansea) and Bristol. The main aim is to see whether it is feasible to preform a positron emission tomography-computed tomography (PET-CT) scan after 2 weeks of radiotherapy and re-plan the radiotherapy based on this PET-CT scan, to re-distribute the dose of radiotherapy being delivered, so that a smaller area of normal tissues in the mouth and throat are treated to a high dose of radiotherapy.
PEARL is a prospective, interventional, non-randomised, phase II feasibility study for
patients with good prognosis Human Papillomavirus (HPV)-associated oropharyngeal squamous
cell cancer (OPSCC) who are suitable for treatment with concurrent chemo-radiotherapy (CCRT).
The incidence of oropharyngeal squamous cell carcinoma (OPSCC) caused by Human Papillomavirus
(HPV) infection (HPV-positive OPSCC) is increasing in the United Kingdom. It tends to affect
younger patients and has a better outcome than most other head and neck cancers.
A large proportion of patients diagnosed with HPV-positive OPSCC will undergo non-surgical
treatment. This usually involves 6 to 7 weeks of chemo-radiotherapy, with chemotherapy being
given weekly or during the first and fourth week of the radiotherapy course (CCRT). Many
patients with HPV-positive OPSCC are cured of their disease but often have to live for
several decades with the side effects of their treatment. Side effects from radiotherapy are
usually caused because normal tissues surrounding the cancer receive radiation whilst the
cancer itself is being treated.
Positron emission tomography-computed tomography (PET-CT) scans are able to look at the
metabolic (or biological) activity of cells and are currently recommended in the UK for
response assessment after a patient has completed radiotherapy for a head and neck cancer
but, as far as we know, have not yet been used routinely to adapt radiotherapy according to
the individual patient's response during radiotherapy.
PEARL will explore the feasibility of individually adapting the radiotherapy plan for each
patient after 2 weeks of radical CCRT, based on biological changes in tumour activity seen on
an interim FDG-PET-CT scan, carried out early on during a course of treatment. The aim is to
reduce the dose of radiotherapy received by surrounding normal tissues to ultimately reduce
toxicity.
The study will establish the progression free survival rate (PFS) in patients who receive
biologically adapted radiotherapy. Furthermore, it will also explore whether changes seen on
PET-CT scan during treatment correlate with outcome and with changes in potential blood-based
biomarkers of response. Toxicity rates will be assessed, particularly the effect of treatment
on swallowing function.
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