Trial record 2 of 71 for:    cholangiocarcinoma | Open Studies | Exclude Unknown | "Cholangiocarcinoma"

Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma (TRANSPHIL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02232932
First received: August 6, 2014
Last updated: September 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cholangiocarcinoma
Morphological Diagnosis of Hilar Cholangiocarcinoma (Excluded Type 1), Resectable With Expected R0 Margins on an intent-to Treat Basis.
Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation
Procedure: RESECTION

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Overall survival [ Time Frame: At 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence free survival [ Time Frame: At 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAPECITABINE-Radiotherapy -Liver Transplantation
Neoadjuvant Radio-Chemotherapy (RC) and Liver Transplantation (LT)
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
Active Comparator: RESECTION
Liver resection
Procedure: RESECTION
Intent-to-treat R0 liver resection
Other Name: Liver Resection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (male or female) aged from 18 to 65 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
  • Percutaneous biliary drainage
  • Positive dosage of ImmunoglobulinsG4 (IgG4)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02232932

Contacts
Contact: Eric VIBERT, MD +33 (0)1 45 59 64 25 eric.vibert.pbr@pbr.aphp.fr
Contact: Emmanuel BOLESLAWSKI, MD +33 (0)3 20 44 60 71 emmanuel.boleslawski@gmail.com

Locations
France
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire Recruiting
Villejuif, France, 94
Contact: Isabelle BRINDEL    +33 (0)1 44 84 17 80    isabelle.brindel@drc.aphp.fr   
Contact: Laina N'DIAYE    +33 (0)1 45 21 31 72    laina.ndiaye@bct.aphp.fr   
Principal Investigator: Eric VIBERT, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Eric VIBERT, MD AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire, Villejuif, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02232932     History of Changes
Other Study ID Numbers: P120106
Study First Received: August 6, 2014
Last Updated: September 3, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hilar cholangiocarcinoma
Liver transplantation
Radiochemotherapy

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin's Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Extracts
Capecitabine
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014