- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01549795
Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy
Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Umberto Cillo, MD
- Phone Number: +390498218547
- Email: cillo@unipd.it
Study Contact Backup
- Name: Enrico Gringeri, MD
- Phone Number: +390498218547
- Email: enrico.gringeri@unipd.it
Study Locations
-
-
-
Padova, Italy, 35100
- Recruiting
- Azienda Ospedaliera di Padova
-
Contact:
- Umberto Cillo, MD
- Phone Number: +390498218547
- Email: cillo@unipd.it
-
Contact:
- Enrico Gringeri, MD
- Phone Number: +390498218547
- Email: enrico.gringeri@unipd.it
-
Sub-Investigator:
- Domenico Bassi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Exclusion Criteria:
- Intrahepatic Cholangiocarcinoma
- Non controlled infection
- Previous radio or chemotherapy
- Previsous bile duct resection or attempt to resection
- Intra and/or extrahepatic metastasis
- Preivious malignant neoplasm (within 5 years)
- Execution of trans peritoneal biopsy
- Tumour diameter more than 3 cm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients free of disease at 24 months post-transplant
Time Frame: 24 months
|
24 months
|
Time to recurrence after liver transplant
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression disease free survival
Time Frame: 24 months
|
24 months
|
Overall 2 years survival after liver transplantation
Time Frame: 24 months
|
24 months
|
Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enrico Gringeri, MD, Azienda Ospedaliera di Padova
Publications and helpful links
General Publications
- Hemming AW, Reed AI, Fujita S, Foley DP, Howard RJ. Surgical management of hilar cholangiocarcinoma. Ann Surg. 2005 May;241(5):693-9; discussion 699-702. doi: 10.1097/01.sla.0000160701.38945.82.
- Rea DJ, Heimbach JK, Rosen CB, Haddock MG, Alberts SR, Kremers WK, Gores GJ, Nagorney DM. Liver transplantation with neoadjuvant chemoradiation is more effective than resection for hilar cholangiocarcinoma. Ann Surg. 2005 Sep;242(3):451-8; discussion 458-61. doi: 10.1097/01.sla.0000179678.13285.fa.
- Rosen CB, Heimbach JK, Gores GJ. Liver transplantation for cholangiocarcinoma. Transpl Int. 2010 Jul;23(7):692-7. doi: 10.1111/j.1432-2277.2010.01108.x. Epub 2010 May 20.
- Hamilton JP. Epigenetic mechanisms involved in the pathogenesis of hepatobiliary malignancies. Epigenomics. 2010 Apr 1;2(2):233-243. doi: 10.2217/epi.10.9.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Biliary Tract Diseases
- Bile Duct Diseases
- Cholangiocarcinoma
- Cholangitis
- Cholangitis, Sclerosing
- Klatskin Tumor
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Hematinics
- Capecitabine
- Liver Extracts
Other Study ID Numbers
- 2372P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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