[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549474":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":45,"locations":22,"responsibleParty":54,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":22,"enrollmentInfo":72,"targetDuration":22,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":22,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":22},{"fullName":5,"class":6},"The Christie NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Proton Beam Therapy","EXPERIMENTAL","All 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), and alongside concurrent oral capecitabine 625mg\u002Fm2 twice daily on radiation days.",[13,14,15,16],"Radiation: Proton Beam Therapy","Drug: Concurrent oral capecitabine chemotherapy","Drug: Cisplatin & Gemcitabine intravenous chemotherapy","Procedure: Orthotropic Liver Transplant",[18,23,28,32],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"RADIATION","All 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)",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","Concurrent oral capecitabine chemotherapy","All patients to be offered concurrent oral capecitabine 625mg\u002Fm2 twice daily on radiation days",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Cisplatin & Gemcitabine intravenous chemotherapy","Following 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.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":22},"PROCEDURE","Orthotropic Liver Transplant","If still eligible after neoadjuvant treatment (PBT + capecitabine), patients will be added to the liver transplant waiting list.",[9],[38,42],{"name":39,"affiliation":40,"role":41},"Maria Hawkins","University College, London","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":44,"role":41},"Douglas Thorburn","The Royal Free NHS Foundation Trust",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":22,"email":50},"Romelie Rieu","CONTACT","0044 1619187172","romelie.rieu@nhs.net",{"name":52,"role":48,"phone":49,"phoneExt":22,"email":53},"Sally Falk","sally.falk@nhs.net",{"type":55,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[57,59,60],{"name":58,"class":6},"University College London Hospitals",{"name":40,"class":6},{"name":61,"class":6},"Royal Free Hospital NHS Foundation Trust","100549474","evaluation-of-combined-modality-protons-and-hepatic-transplantation-for-hilar-cholangiocarcinoma-100549474",false,"NCT06434493","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)","EMPHATIC","Inclusion Criteria:\n\nGeneral criteria\n\n* Age 17 years and over\n* Performance status 0 or 1 (Eastern Cooperative Oncology Group)\n* Suitable for liver transplantation as determined by Multi Disciplinary Team (MDT)\n* Able to tolerate neoadjuvant therapy.\n* 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 \u002F 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.\n\nSpecific criteria\n\n* Presence of a dominant hilar stricture or mass \\\u003C3cm on cross-sectional imaging\n* Histologically proven cholangiocarcinoma by brush cytology or biopsy via Endoscopic Retrograde Cholangiopancreatography (ERCP) or Percutaneous Transhepatic Cholangiography (PTC)\n* No metastatic disease, including to regional lymph nodes.\n\nExclusion Criteria:\n\nGeneral criteria\n\n* Inability to consent\n* Poor performance status\n* Failed fitness assessment\n* Extrahepatic disease at any stage of presentation, assessment and treatment\n* Prior biliary resection or hilar dissection for attempted resection within the past 12 months\n* Prior malignancy in the last 5 years (excluding early breast, prostate, cervix and non melanoma skin cancers)\n\nSpecific criteria\n\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C30\n* Prior radiation to the upper abdomen\n* Uncontrolled infection\n* Duodenal invasion","ALL","17 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nEvaluative 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.\n\nThe 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.\n\nEMPHATIC 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).\n\nEMPHATIC 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.",[80],"Cholangiocarcinoma",[82,83,84,85],"proton beam therapy","protons","evaluative commissioning","liver transplant","NOT_YET_RECRUITING","2024-08-20",{"date":89,"type":90},"2024-08-21","ACTUAL",{"date":92,"type":74},"2024-11-01",{"date":94,"type":74},"2029-06-01",{"name":5,"class":6}]