Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT treatment.
Evaluative Commissioning in Protons (ECIP) is a programme of studies that explore the role of PBT for patients with different types of cancer. They are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered proton therapy. Any patient in the United Kingdom (UK) can be referred, and for patients that need to travel far to their nearest centre, accommodation will be available.
The main benefit of PBT, compared with photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.
PRONTO is a study within the ECIP programme exploring whether PBT can reduce treatment side effects for patients with salivary gland cancers who need radiotherapy following surgery. Whilst radiotherapy is associated with good cancer control, it commonly causes problematic side-effects such as loss of taste and dry mouth. These can be permanent and can negatively affect someone's quality of life. PRONTO's main aim is to see if PBT can reduce the loss of taste following radiotherapy.
Participants in PRONTO will be closely monitored by the medical team and with questionnaires. The patient experience will be compared to what we would expect with standard photon radiotherapy.
≥ 18 years old.
Histologically confirmed primary malignant tumours of parotid gland.
Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction.
Treatment delivered with radical intent.
Previous radiotherapy to the head and neck region;
Parotid tumours requiring primary radiation or those with gross residual disease;
Metastases from squamous cell carcinoma of the head and neck to the parotid gland;
Benign tumours requiring post operative radiotherapy;
Single group
Proton Beam Therapy
RadiationAll patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks.
Taste dysfunction
Taste dysfunction as recorded on the European Organisation for the Research \& Treatment of Cancer (EORTC) Head \& Neck 43 (HN43) patient reported questionnaire. 43 questions with a Likert scale of 1 - 4 Higher score may mean a worse outcome
Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades
Using the CTCAE toxicity grade Grades 1 - 5 Higher score may mean a worse outcome
Clinician reported acute and late toxicity using Late Effects Normal Tissue - Subjective Objective Management Analytic (LENT-SOMA) scale
Using the LENT-SOMA scale A multiple item scoring system composed of four domains; subjective, objective, management and analytic. Grades 0-4 Higher score may mean a worse outcome
Clinician reported acute and late toxicity - measurement of hearing changes
Using pure tone audiometry to measure hearing changes Loss of hearing may mean a worse outcome
Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 module questionnaire
Using the EORTC QLQ-C30 30 questions using a Likert scale of 1-4 Higher score may mean a worse outcome
Click on the lead sponsor to view all of their trials.
The Christie NHS Foundation Trust
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
University College London Hospitals
Collaborator
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