Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom (UK), in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT.
Evaluative Commissioning in Protons (ECIP) is a programme of studies exploring the role of PBT in different types of cancer. The studies are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered PBT. Any eligible patient in the UK can be referred, and accommodation is available for patients who don't live close to a PBT centre.
The main benefit of PBT, compared with standard 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.
EMPHATIC is a study within the ECIP programme. In EMPHATIC, the investigators are looking to see whether a combination of treatments, including PBT, chemotherapy and a liver transplant, can be used to treat patients with cholangiocarcinoma (bile duct cancer).
EMPHATIC offers patients whose cancer can't be removed with surgery (unresectable) a potentially curative treatment option. There is evidence that liver transplant is a curative treatment option in patients with cholangiocarcinoma. There is a risk that the cancer may grow or spread whilst waiting for a transplant, potentially making patients ineligible. PBT and chemotherapy is thought to be the best way to control the cancer, until a liver transplant can be performed. EMPHATIC will look at how a combination of PBT and chemotherapy, followed by a liver transplant, can be used to curatively treat patients with unresectable cholangiocarcinomas.
Age 17 years and over
Performance status 0 or 1 (Eastern Cooperative Oncology Group)
Suitable for liver transplantation as determined by Multi Disciplinary Team (MDT)
Able to tolerate neoadjuvant therapy.
Inability to consent
Poor performance status
Failed fitness assessment
Extrahepatic disease at any stage of presentation, assessment and treatment
Single group
Proton Beam Therapy
RadiationAll patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy)
Concurrent oral capecitabine chemotherapy
DrugAll patients to be offered concurrent oral capecitabine 625mg/m2 twice daily on radiation days
Cisplatin & Gemcitabine intravenous chemotherapy
DrugFollowing chemoradiotherapy (PBT + capecitabine), and whilst on the liver transplant waiting list, patients will be offered up to 6 cycles of standard chemotherapy with cisplatin and gemcitabine.
Orthotropic Liver Transplant
Procedure/SurgeryIf still eligible after neoadjuvant treatment (PBT + capecitabine), patients will be added to the liver transplant waiting list.
Incidence of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity
Incidence of Grade ≥ 3 toxicity using CTCAE (grades 0-5) up to 90 days following completion of neoadjuvant (chemo)-PBT and liver transplant. Higher score indicates worse outcome.
Proportion of patients who undergo a successful liver transplant
The proportion of patients who, following neoadjuvant (chemo)-PBT, undergo a successful liver transplant (measured at 90 days post-transplant).
Number of patients completing planned radiotherapy
Number of patients completing planned radiotherapy
Incidence of severe treatment related side effects
Rate of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity (Grades 0-5). Higher score may mean a worse outcome.
1 year post completion of neoadjuvant therapy cancer-related mortality
Calculated from date of last PBT treatment and defined as time to death or censoring at 1 year.
1 year post transplant overall survival
Calculated from date of liver transplant and defined as time to death or censoring at 1 year.
Click on the lead sponsor to view all of their trials.
The Christie NHS Foundation Trust
Lead sponsor
University College London Hospitals
Collaborator
University College, London
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
