Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-06 @ 10:08 PM
Study NCT ID:
NCT00356161
Status:
UNKNOWN
Last Update Posted:
2006-07-25
First Post:
2006-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HAI Via Interventionally Implanted Port Catheter Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2008-04'}, 'lastUpdateSubmitDate': '2006-07-24', 'studyFirstSubmitDate': '2006-07-24', 'studyFirstSubmitQcDate': '2006-07-24', 'lastUpdatePostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of evaluation and intervention group'}, {'measure': 'Complication rate (device implantation)'}, {'measure': 'Safety of device and regional therapy'}], 'secondaryOutcomes': [{'measure': 'prospective evaluation of port duration'}, {'measure': 'comparison of complication and port duration with an historical collective of patients provided with a surgically implanted hepatic arterial port catheter system (liver metastases of colorectal cancer)'}, {'measure': 'response'}, {'measure': 'progression free and overall survival'}, {'measure': 'efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study'}, {'measure': 'quality of life'}]}, 'conditionsModule': {'keywords': ['colorectal neoplasms', 'hepatocellular carcinoma', 'gallbladder cancer', 'bile duct cancer', 'hepatic arterial infusion'], 'conditions': ['Colorectal Cancer', 'Liver Neoplasms', 'Hepatocellular Carcinoma', 'Gallbladder Cancer', 'Bile Duct Cancer']}, 'referencesModule': {'references': [{'pmid': '15297586', 'type': 'BACKGROUND', 'citation': 'Ricke J, Hildebrandt B, Miersch A, Nicolaou A, Warschewske G, Teichgraber U, Lopez Hanninen E, Riess H, Felix R. Hepatic arterial port systems for treatment of liver metastases: factors affecting patency and adverse events. J Vasc Interv Radiol. 2004 Aug;15(8):825-33. doi: 10.1097/01.RVI.0000136992.96374.60.'}]}, 'descriptionModule': {'briefSummary': 'Procedures to provide interventional implantation of a port catheter system into the hepatic artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open, single-arm trial in patients with metastases and cancers confined to the liver. The primary objective is the improvement of indication, implantation procedure, and regional chemotherapy. Secondary objectives are port patency, comparison of complications with a historical collective of patients provided with a surgical hepatic arterial port device (colorectal cancer patients only), progression free and overall survival, efficacy of maintaining regional chemotherapy with 5-FU in combination with systemic treatment in patients with extrahepatic progression, quality of life.', 'detailedDescription': 'Inclusion criteria:\n\n* histologically confirmed hepatic cancer without symptomatic extrahepatic manifestation.\n* non-resectable disease or hepatic resection or ablation in between the past 8 weeks.\n* measurable disease (at least before hepatic resection)\n* Karnofsky performance status =\\> 70%, or ECOG status 0-2\n* \\>18 years of age\n* life expectancy \\> 6 months\n* compliance of the patient\n* written informed consent\n\nExclusion criteria:\n\n* second neoplasia within the past 3 years, except for non-melanotic skin cancer, adequately treated Ca in situ of cervix uteri, or adequately resected second colorectal cancer (in patients with liver metastases of colorectal cancer)\n* symptomatic extrahepatic disease, in particular disseminated bone metastases, brain metastases\n* liver cirrhosis with portal hypertension, active hepatitis B or C, previous percutaneous radiotherapy of the liver\n* active infection\n* history of gastric or duodenal ulcer\n* symptomatic or uncontrolled peripheral arterial occlusive disease, history of stenosis of the renal artery.\n* history of dilatative cardiomyopathy, vitium of mitral or aortic valve, persisting foramen ovale, atrial fibrillation\n* artificial heart valve or vascular\n* history of diabetic microangiopathy\n* uncontrolled hyperthyriodism\n* other severe concomitant disease (heart failure \\>NYHA 2°, respiratory failure, renal failure \\>stage2, liver failure (TPZ \\<50%).\n* inherited or acquired immunodeficiency syndrome\n* contraindication against 5-FU\n* pregnancy and nursing, no contraception\n* limited contractual capability.\n\nAfter enrollment, an a port catheter catheter system is interventionally implanted into the hepatic artery and the patient is scheduled for regional chemotherapy according one out of 8 pre-defined chemotherapy schedules. All regimens are based on 5-fluorouracil and leucovorin, and optionally contain intraarterial mitomycin, oxaliplatin, or additional intravenous irinotecan.\n\nPatients are followed up and evaluated for primary and secondary endpoints. After the inclusion of 50 patients treated and follow up at our institution, the study population has been extended to 100 patients in 8/2004.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsee above\n\nExclusion Criteria:\n\nsee above'}, 'identificationModule': {'nctId': 'NCT00356161', 'briefTitle': 'HAI Via Interventionally Implanted Port Catheter Systems', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Open One-Arm Therapy Optimizing Trial on Regional Chemotherapy of the Liver Through an Interventionally Implanted A.Hepatica Port System in Patients With Liver Metastases or Primary Liver Neoplasms.', 'orgStudyIdInfo': {'id': 'CVK-HAI 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'interventionally implanted hepatic arterial port catheter', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13344', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bert Hildebrandt, MD', 'role': 'CONTACT', 'email': 'bert.hildebrandt@charite.de', 'phone': '++49 30 450 553 636'}, {'name': 'Annett Nicolaou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '39120', 'city': 'Magdeburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maciej Pech, MD', 'role': 'CONTACT', 'email': 'radiologie@uni-magdeburg.de', 'phone': '+49 391 67-13030'}], 'facility': 'Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'centralContacts': [{'name': 'Bert Hildebrandt, MD', 'role': 'CONTACT', 'email': 'bert.hildebrandt@charite.de', 'phone': '++49 30 450 553636'}, {'name': 'Hanno Riess, MD, PhD', 'role': 'CONTACT', 'email': 'hanno.riess@charite.de', 'phone': '++49 30 450 553112'}], 'overallOfficials': [{'name': 'Bert Hildebrandt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Charté Centrum Tumormedizin, CVK, D-13344 Berlin'}, {'name': 'Hanno Riess, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Charité Centrum Tumormedizin, CVK, D-13344 Berlin'}, {'name': 'Jens Ricke, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 Magdeburg'}, {'name': 'Roland Felix, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinik für Strahlenheilkunde, CVK, Charité Universitätsmedizin Berlin, D-13344 Berlin'}, {'name': 'Peter Neuhaus, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Charité Centrum Chirurgische Medizin, CVK, D-13344 Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}}}}