Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 6:54 PM
Study NCT ID:
NCT01549795
Status:
UNKNOWN
Last Update Posted:
2012-07-18
First Post:
2012-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018285', 'term': 'Klatskin Tumor'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2012-03-07', 'studyFirstSubmitQcDate': '2012-03-08', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients free of disease at 24 months post-transplant', 'timeFrame': '24 months'}, {'measure': 'Time to recurrence after liver transplant', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Progression disease free survival', 'timeFrame': '24 months'}, {'measure': 'Overall 2 years survival after liver transplantation', 'timeFrame': '24 months'}, {'measure': 'Complication rate due to radiotherapy (Hepatic artery thrombosis and Portal vein thrombosis)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver transplantation', 'Neoadjuvant radio- chemo-therapy'], 'conditions': ['Hilar Cholangiocarcinoma', 'Primary Sclerosing Cholangitis']}, 'referencesModule': {'references': [{'pmid': '15849505', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16135931', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20497401', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20556199', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.fegatochirurgia.com', 'label': 'Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nCholangiocarcinoma (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%.\n\nNew 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Male or female\n* Diagnosis of Cholangiocarcinoma using:\n* PTBD biopsy or Brushing cytology\n* Ca 19-9\\>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,\n* Non resectable tumour araising above the cystic duct\n* Absence of intra and extra hepatic metastasis\n* ECOG score(Eastern Cooperative Oncology Group) 0\n* ASA score (American Society of Anesthesiologists) ≤ 3\n* Ability to understand and willingness to sign the written informed consent form (ICF)\n\nExclusion Criteria:\n\n* Intrahepatic Cholangiocarcinoma\n* Non controlled infection\n* Previous radio or chemotherapy\n* Previsous bile duct resection or attempt to resection\n* Intra and/or extrahepatic metastasis\n* Preivious malignant neoplasm (within 5 years)\n* Execution of trans peritoneal biopsy\n* Tumour diameter more than 3 cm'}, 'identificationModule': {'nctId': 'NCT01549795', 'briefTitle': 'Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera di Padova'}, 'officialTitle': 'Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante', 'orgStudyIdInfo': {'id': '2372P'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'description': 'Liver transplantation using classic technique and avoiding proximal ilum dissection. The donor hepatic artery will be anastomosed to a jump graft connected to the Aorta. In case of positive margin of the bile duct at a frozen section analysis the liver transplant will be performed after an adjunctive pancreatodudodenctomy'}, {'name': '45 Gy external radiations', 'type': 'RADIATION', 'description': '45 Gy in 30 fractions, 1,5 Gy twice a day) and 5-FU iv infusion- 3 week treatment'}, {'name': 'Endoluminal bile duct Brachytherapy', 'type': 'RADIATION', 'description': 'Brachytherapy (20 Gy a 1 cm in 20-25h) - administered 2 weeks after radiotherapy completion'}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine - administered till liver transplantation'}, {'name': 'Pre liver transplantation laparoscopic hand assisted staging', 'type': 'PROCEDURE', 'description': 'Pre liver transplantation laparoscopic hand assisted staging for sampling hepatic artery lymph nodes and assessing peritoneal disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Padua', 'state': 'Padova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Umberto Cillo, MD', 'role': 'CONTACT', 'email': 'cillo@unipd.it', 'phone': '+390498218547'}, {'name': 'Enrico Gringeri, MD', 'role': 'CONTACT', 'email': 'enrico.gringeri@unipd.it', 'phone': '+390498218547'}, {'name': 'Umberto Cillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Enrico Gringeri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Domenico Bassi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giacomo Zanus, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniele Neri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Francesco D'Amico, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alessandro Vitale, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Umberto Cillo, MD', 'role': 'CONTACT', 'email': 'cillo@unipd.it', 'phone': '+390498218547'}, {'name': 'Enrico Gringeri, MD', 'role': 'CONTACT', 'email': 'enrico.gringeri@unipd.it', 'phone': '+390498218547'}], 'overallOfficials': [{'name': 'Umberto Cillo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Azienda Ospedaliera di Padova'}, {'name': 'Enrico Gringeri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera di Padova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera di Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Hepatobiliary Surgery and Liver Transplantation Unit', 'investigatorFullName': 'Prof. Umberto Cillo', 'investigatorAffiliation': 'Azienda Ospedaliera di Padova'}}}}