Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma

NCT02232932 | Unknown DMC

• 1 other identifier: P120106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Hilar cholangiocarcinoma; Liver transplantation; Radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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

  At 5 years

Secondary Outcomes (1)

• Recurrence free survival

  At 3 years

Study Arms (2)

CAPECITABINE-Radiotherapy -Liver Transplantation

EXPERIMENTAL

Neoadjuvant Radio-Chemotherapy (RC) and Liver Transplantation (LT)

Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation

RESECTION

ACTIVE COMPARATOR

Liver resection

Procedure: RESECTION

Interventions

CAPECITABINE-Radiotherapy -Liver Transplantation PROCEDURE

CAPECITABINE (800 mg/m2 twice a day during 5 weeks) + External Radiotherapy (50 grays during 5 weeks) then Liver transplantation

Also known as: Neoadjuvant Radio-Chemotherapy and Liver Transplantation

CAPECITABINE-Radiotherapy -Liver Transplantation

RESECTION PROCEDURE

Intent-to-treat R0 liver resection

Also known as: Liver Resection

RESECTION

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Villejuif, 94, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Klatskin Tumor

Interventions

Liver Transplantation; Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Eric VIBERT, MD

  AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire, Villejuif, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: September 5, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

FR (1)