EMPHATIC
Research type
Research Study
Full title
Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma (EMPHATIC) - An Evaluative Commissioning in Protons (ECIP) programme study.
IRAS ID
338323
Contact name
Maria Hawkins
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Proton Beam Therapy (PBT) and Evaluative Commissioning in Protons (ECIP):
PBT is an advanced radiotherapy technique. There are two NHS PBT treatment centres in the 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.
ECIP is a programme of studies exploring the role of PBT in different types of cancer. They are funded by NHS England. ECIP studies are not randomised, 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:
EMPHATIC is a study within the ECIP programme. In EMPHATIC, we are looking to see whether a combination of treatments, including PBT, standard 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 standard chemotherapy, followed by liver transplant, can be used to curatively treat patients with unresectable cholangiocarcinomas.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
24/NW/0292
Date of REC Opinion
21 Nov 2024
REC opinion
Further Information Favourable Opinion