NCT06434493Not yet recruiting
Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma
Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma (an Evaluative Commissioning in Protons Study)
Source: ClinicalTrials.gov · Last updated 21 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Apr 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- The Christie NHS Foundation Trust
- NCT number
- NCT06434493
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Nov 2024 to the primary completion date, 1 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior biliary resection or hilar dissection for attempted resection within the past 12 months
- Prior radiation to the upper abdomen
Other illness
- Extrahepatic disease at any stage of presentation, assessment and treatment
- Prior malignancy in the last 5 years (excluding early breast, prostate, cervix and non melanoma skin cancers)
- Specific criteria
- Uncontrolled infection
Lab values
- Estimated Glomerular Filtration Rate (eGFR) \<30
Other
- General criteria
- Inability to consent
- Poor performance status
- Failed fitness assessment
- Duodenal invasion
Who the study is looking for
- General criteria
- 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.
- A history of primary sclerosing cholangitis (PSC) will be a necessary eligibility criterion at the start of the study. Part-way through recruitment to the study, the eligibility criteria may be broadened, allowing patients with sporadic / non-PSC unresectable cholangiocarcinoma to also be considered. The decision to do this will be taken by the Study Management Group, who will be monitor results closely, following an interim analysis after the first 10 patients. Suitability for Orthotropic Liver Transplant will continue to be confirmed in the regional Hepato Biliary cancer MDT.
- Specific criteria
- Presence of a dominant hilar stricture or mass \<3cm on cross-sectional imaging
- Histologically proven cholangiocarcinoma by brush cytology or biopsy via Endoscopic Retrograde Cholangiopancreatography (ERCP) or Percutaneous Transhepatic Cholangiography (PTC)
- No metastatic disease, including to regional lymph nodes.
Age in the registry: 17 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.