Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy

Sponsor

Azienda Ospedaliera di Padova (Other)

Overall Status

Unknown status

CT.gov ID

NCT01549795

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.

Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.

New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.

Condition or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma Primary Sclerosing Cholangitis	Procedure: Liver transplantation Radiation: 45 Gy external radiations Radiation: Endoluminal bile duct Brachytherapy Drug: Capecitabine Procedure: Pre liver transplantation laparoscopic hand assisted staging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2013

Outcome Measures

Primary Outcome Measures

Percentage of patients free of disease at 24 months post-transplant [24 months]
Time to recurrence after liver transplant [24 months]

Secondary Outcome Measures

Progression disease free survival [24 months]
Overall 2 years survival after liver transplantation [24 months]
Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis) [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Older than 18 years
Male or female
Diagnosis of Cholangiocarcinoma using:
PTBD biopsy or Brushing cytology
Ca 19-9>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
Non resectable tumour araising above the cystic duct
Absence of intra and extra hepatic metastasis
ECOG score(Eastern Cooperative Oncology Group) 0
ASA score (American Society of Anesthesiologists) ≤ 3
Ability to understand and willingness to sign the written informed consent form (ICF)