Evaluative Commissioning in Protons (ECIP) programme & PRONTO study
Research type
Research Study
Full title
Evaluative Commissioning in Protons (ECIP) Programme Master Protocol & PRONTO - An evaluative commissioning study to investigate the role of adjuvant proton beam radiotherapy in patients with localised parotid carcinoma.
IRAS ID
320864
Contact name
Ed Smith
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CFTSp218, ECIP Programme Master Protocol; CFTSp218 (01), ECIP Programme PRONTO study
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Proton Beam Therapy (PBT) and Evaluative Commissioning in Protons (ECIP):
Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two 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 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:
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.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0260
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Favourable Opinion