Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Christie NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

≥ 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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Proton Beam Therapy

Treatment groups

97 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

The Christie NHS Foundation Trust

Lead sponsor

Royal Marsden NHS Foundation Trust

Collaborator

University College London Hospitals

Collaborator