Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01016002
Status:
UNKNOWN
Last Update Posted:
2009-11-18
First Post:
2009-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C072269', 'term': 'temoporfin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2009-11-16', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT', 'timeFrame': 'post treatment'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival time, overall survival time', 'timeFrame': 'Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention'}, {'measure': 'Toxicity using WHO criteria and criteria for local toxicity in the biliary system', 'timeFrame': 'Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-curative Resectable Bile Duct Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:\n\n 1. Bismuth type III or IV ( not resectable with R0-margins )\n 2. Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient\n* sufficient general condition to undergo PDT (Karnofsky status \\> 30%)\n* age \\> 19 years\n* access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),\n* informed written consent\n\nExclusion Criteria:\n\n* porphyria or other diseases exacerbated by light\n* known intolerance or allergies to porphyrin derivatives\n* a planned surgical procedure within the next 30 days\n* coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days\n* impaired kidney or liver function (creatinine \\> 2.5x elevated, INR \\> 2.2 on vitamin K),\n* leukopenia ( WBC \\< 2000/cmm ) or thrombopenia ( \\< 50000/cmm ),\n* cytotoxic chemotherapy within the past 4 weeks.\n* pregnancy ( and safe contraception for 6 months after PDT )\n* accompanying/complicating disease with very poor prognosis (expected survival \\< 6 weeks),\n* proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)'}, 'identificationModule': {'nctId': 'NCT01016002', 'briefTitle': 'Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Salzburg'}, 'officialTitle': 'A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma', 'orgStudyIdInfo': {'id': 'Foscan 1/2005'}, 'secondaryIdInfos': [{'id': 'EUDRA CT 2005-004866-17'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Drug: Temoporfin']}], 'interventions': [{'name': 'Temoporfin', 'type': 'DRUG', 'otherNames': ['Foscan', 'Meso-tetrahydroxyphenyl Chlorin'], 'description': 'Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min.\n\nLaser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Frieder Berr, Prof., MD', 'role': 'CONTACT', 'email': 'f.berr@salk.at'}, {'name': 'Frieder Berr, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Internal Medicine I, Paracelsus Medical University Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'A. Lohse, Prof., MD', 'role': 'CONTACT', 'email': 'alohse@uke-uni-hamburg.de'}, {'name': 'A. Lohse, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Internal Medicine Dept., University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Frieder Berr, Prof., MD', 'role': 'CONTACT', 'email': 'f.berr@salk.at', 'phone': '(43-) 662-4482', 'phoneExt': '2800'}, {'name': 'Lohse A, Prof., MD', 'role': 'CONTACT', 'email': 'alohse@uke-uni-hamburg.de', 'phone': '+49-(0)40-4280', 'phoneExt': '33 910'}], 'overallOfficials': [{'name': 'Frieder Berr, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria'}, {'name': 'Lohse A, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salzburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biolitec Pharma Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Frieder Berr, M.D.', 'oldOrganization': 'Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria'}}}}