Status:
UNKNOWN
Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief Summary
A prospective, open-label, randomised, multicentre, comparative study in two parallel groups comparing an interventional group with liver transplantation preceded by neoadjuvant radio-chemotherapy and...
Detailed Description
The protocol will comprise a phase 1 during which the potential eligibility of patients (presenting with a resectable Klatskin - Excepted Type 1of Bismuth) will be assessed, based on clinical, biologi...
Eligibility Criteria
Inclusion
- Patients (male or female) aged from 18 to 68 year-old, French
- Hilar cholangiocarcinoma histologically proved and/or highly suspected on hilar stenosis with mass syndrome from 0.1 cm to 3 cm
- Hilar cholangiocarcinoma type 2, type 3A, type 3B, type 4
- Patients considered as resectable (R0 resection) by liver resection including segment 1 and biliary confluence with or without vascular resection
- Patient potentially transplantable
- Patient affiliated to French Health Insurance
- Patient who had sign an informed consent
Exclusion
- Pregnant or breastfeeding woman
- Women of childbearing potential without an effective contraception method
- Radiotherapy contraindication
- Positive dosage of ImmunoglobulinsG4 (IgG4)
- dihydro-pyrimidine-dehydrogenase (DPD) total deficit
- Personal history of cancer in the last 5 five years (exclusion basocellular cellular carcinoma)
- Personal history of fluoropyrimidine hypersensibility
- Personal history of capecitabine hypersensibility
- Personal history of dihydro-pyrimidine-dehydrogenase deficit
- Polynuclear neutrophil \< 1500 / ml
- Platelet rate \< 100 000 / ml
- Severe leucopenia \< 2000 / ml
- Severe liver failure (Factor V \< 50%)
- Severe renal failure (Creatin clearance \< 30 ml/min)
- Treatment by Sorivudine or its analogue as Brivudine
- Non controled diabetes mellitus and/or others severe co-morbidities (renal failure, severe and instable coronaropathy, severe risk factor of stroke, body mass index superior to 35)
- Proved histological cirrhosis
- Sclerosing cholangitis
- Intra and/or extra-hepatic metastases
- Hypereosinophilia and/or wirsung dilatation and/or mass of the pancreas head
- Hilar mass superior to 3 cm
- Duodenal invasion
- Patient under guardianship
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02232932
Start Date
March 1 2014
End Date
September 1 2024
Last Update
November 3 2021
Active Locations (1)
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1
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, France, 94