Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante |
- Percentage of patients free of disease at 24 months post-transplant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time to recurrence after liver transplant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Progression disease free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Overall 2 years survival after liver transplantation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
-
Procedure: Liver transplantation
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Umberto Cillo, MD | +390498218547 | cillo@unipd.it |
| Contact: Enrico Gringeri, MD | +390498218547 | enrico.gringeri@unipd.it |
| Italy | |
| Azienda Ospedaliera di Padova | Recruiting |
| Padova, Italy, 35100 | |
| Contact: Umberto Cillo, MD +390498218547 cillo@unipd.it | |
| Contact: Enrico Gringeri, MD +390498218547 enrico.gringeri@unipd.it | |
| Principal Investigator: Umberto Cillo, MD | |
| Sub-Investigator: Enrico Gringeri, MD | |
| Sub-Investigator: Domenico Bassi, MD | |
| Sub-Investigator: Giacomo Zanus, MD | |
| Sub-Investigator: Daniele Neri, MD | |
| Sub-Investigator: Francesco D'Amico, MD | |
| Sub-Investigator: Alessandro Vitale, MD | |
| Study Chair: | Umberto Cillo, MD | Azienda Ospedaliera di Padova |
| Principal Investigator: | Enrico Gringeri, MD | Azienda Ospedaliera di Padova |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova |
| ClinicalTrials.gov Identifier: | NCT01549795 History of Changes |
| Other Study ID Numbers: | 2372P |
| Study First Received: | March 7, 2012 |
| Last Updated: | July 17, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Azienda Ospedaliera di Padova:
|
Liver transplantation Neoadjuvant radio- chemo-therapy |
Additional relevant MeSH terms:
|
Cholangitis Cholangitis, Sclerosing Cholangiocarcinoma Klatskin's Tumor Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013