Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02232932 |
| Other study ID # |
P120106 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2014 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
October 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
