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Trial record 1 of 1 for:    transphil
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Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma (TRANSPHIL)

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ClinicalTrials.gov Identifier: NCT02232932
Recruitment Status : Active, not recruiting
First Posted : September 5, 2014
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE August 6, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date July 7, 2020
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Overall survival [ Time Frame: At 5 years ]
To demonstrate the superiority, in terms of 5-year survival, of liver transplantation (TH) preceded by neoadjuvant chemoradiotherapy on the radical resection of Klatskin tumors considered resectable
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
Overall survival [ Time Frame: At 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Recurrence free survival [ Time Frame: At 3 years ]
3-year recurrence-free survival assessed by CT and markers
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
Recurrence free survival [ Time Frame: At 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma
Official Title  ICMJE Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma
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 a control group receiving conventional liver and bile duct resection.

The primary endpoint will be overall survival at 5 years in the intent-to-treat population. The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the intent-to-treat population.

The number of subjects necessary is 54 patients (27 x 2): this population will enable the demonstration of a significant difference is 5-year survival rates between the transplanted group and the resected group with a power of 80% and a first-species risk of 5%, under the hypothesis that these survival rates are 70% in the transplanted group and 30% in the resected group.

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, biological and morphological data. After phases 1, the eligibility of the patient will be confirmed or not. In the context of the study, phase 2 will include the collection of blood samples as well as positon emission tomography (PET)-scan and upper endoscopic ultrasound (EUS) in order to rule out any obvious lymph node metastases. A short exploratory laparoscopy will also be performed in phase 2 to eliminate infra-clinic subcapsular liver metastases and peritoneal carcinomatosis. The randomization process will take place at the end of the phase 2, patients will be assigned into the transplantation arm (OLT) or the resection arm (RSX). During phase 3, patient will receive nutritional support and, if not done previously, a biliary drainage will be placed endoscopically. In the RSX arm (phase 3A), patients will undergo radical resection of the tumor (refer below technical details). Preoperative portal vein embolization may be necessary at this stage depending on the expected remnant liver volume, assessed by CT-scan volumetry. In the OLT arm (phase 3A), patients will receive neoadjuvant radiochemotherapy (External - 50 grays) following by liver transplantation (phase 4B). Before the fifth week after completion of radiochemotherapy, a staging laparotomy with local lymphadenectomy will be performed and patients will be put on the national waiting list in the absence of extra-hepatic disease, especially peritoneal seeding and lymph nodes involvement. A score exception will allowed a liver transplantation in the 3 months after staging laparotomy. During phase 5 the patient will be monitored postoperatively at the clinical, biological and morphological levels for 3 months. During phase 6, the patient will be followed clinically, biologically and morphologically for 5 years in order to detect any recurrence and in the context of standard clinical care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholangiocarcinoma
Intervention  ICMJE
  • Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation
    CAPECITABINE (800 mg/m2 twice a day during 5 weeks) + External Radiotherapy (50 grays during 5 weeks) then Liver transplantation
    Other Name: Neoadjuvant Radio-Chemotherapy and Liver Transplantation
  • Procedure: RESECTION
    Intent-to-treat R0 liver resection
    Other Name: Liver Resection
Study Arms  ICMJE
  • Experimental: CAPECITABINE-Radiotherapy -Liver Transplantation
    Neoadjuvant Radio-Chemotherapy (RC) and Liver Transplantation (LT)
    Intervention: Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation
  • Active Comparator: RESECTION
    Liver resection
    Intervention: Procedure: RESECTION
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232932
Other Study ID Numbers  ICMJE P120106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric VIBERT, MD AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire, Villejuif, France
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP