NCT06434493Toborzás még nem indult
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. aug. 21. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2024. ápr. 25.
- Kezdés
- 2024. nov. 1.
- Elsődleges befejezés
- 2028. jún. 1.
- Fő szponzor
- The Christie NHS Foundation Trust
- Betegségek
- Gyermekkori daganatok, Máj- és epeúti rák
- NCT-szám
- NCT06434493
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2024. nov. 1. és az elsődleges befejezés (2028. jún. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior biliary resection or hilar dissection for attempted resection within the past 12 months
- Prior radiation to the upper abdomen
Más betegség
- 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
Laborértékek
- Estimated Glomerular Filtration Rate (eGFR) <30
Egyéb
- General criteria
- Inability to consent
- Poor performance status
- Failed fitness assessment
- Duodenal invasion
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 17 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.