- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016002
Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
November 16, 2009 updated by: University of Salzburg
A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Frieder Berr, Prof., MD
- Phone Number: 2800 (43-) 662-4482
- Email: f.berr@salk.at
Study Contact Backup
- Name: Lohse A, Prof., MD
- Phone Number: 33 910 +49-(0)40-4280
- Email: alohse@uke-uni-hamburg.de
Study Locations
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-
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Salzburg, Austria, 5020
- Recruiting
- Department of Internal Medicine I, Paracelsus Medical University Salzburg
-
Contact:
- Frieder Berr, Prof., MD
- Email: f.berr@salk.at
-
Principal Investigator:
- Frieder Berr, Prof., MD
-
-
-
-
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Hamburg, Germany, 20246
- Recruiting
- Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
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Contact:
- A. Lohse, Prof., MD
- Email: alohse@uke-uni-hamburg.de
-
Principal Investigator:
- A. Lohse, Prof., MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
- Bismuth type III or IV ( not resectable with R0-margins )
- Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
- sufficient general condition to undergo PDT (Karnofsky status > 30%)
- age > 19 years
- access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
- informed written consent
Exclusion Criteria:
- porphyria or other diseases exacerbated by light
- known intolerance or allergies to porphyrin derivatives
- a planned surgical procedure within the next 30 days
- coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
- impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
- leukopenia ( WBC < 2000/cmm ) or thrombopenia ( < 50000/cmm ),
- cytotoxic chemotherapy within the past 4 weeks.
- pregnancy ( and safe contraception for 6 months after PDT )
- accompanying/complicating disease with very poor prognosis (expected survival < 6 weeks),
- proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
Time Frame: post treatment
|
post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival time, overall survival time
Time Frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
|
Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
|
Toxicity using WHO criteria and criteria for local toxicity in the biliary system
Time Frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
|
Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frieder Berr, Prof., MD, Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
- Principal Investigator: Lohse A, Prof., MD, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
November 16, 2009
First Submitted That Met QC Criteria
November 16, 2009
First Posted (Estimate)
November 18, 2009
Study Record Updates
Last Update Posted (Estimate)
November 18, 2009
Last Update Submitted That Met QC Criteria
November 16, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Biliary Tract Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma
- Carcinoma, Ductal
- Bile Duct Neoplasms
- Antineoplastic Agents
- Photosensitizing Agents
- Dermatologic Agents
- Temoporfin
Other Study ID Numbers
- Foscan 1/2005
- EUDRA CT 2005-004866-17
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.
Clinical Trials on Non-curative Resectable Bile Duct Carcinoma
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AIO-Studien-gGmbHServier; Institut für Klinisch-Onkologische Forschung der Krankenhaus Nordwest...Active, not recruitingBiliary Tract Cancer | Extrahepatic Bile Duct Carcinoma | Non-Resectable Hepatocellular Carcinoma | Adenocarcinoma Metastatic | Adenocarcinoma of the Biliary Tract | Adenocarinoma Locally Advanced | Intrahepatic Bile Duct CarcinomaGermany
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Beth Israel Deaconess Medical CenterDana-Farber Cancer Institute; AstraZeneca; Sirtex MedicalRecruitingCholangiocarcinoma | Bile Duct Cancer | Cholangiocarcinoma Non-resectable | Cholangiocarcinoma Metastatic | Metastatic Intrahepatic CholangiocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Liver Carcinoma | Recurrent Adult Liver Carcinoma | Recurrent Gallbladder Carcinoma | Stage IV Distal Bile Duct Cancer | Stage IV Gallbladder Cancer | Unresectable Extrahepatic Bile Duct Carcinoma | Unresectable Gallbladder...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnUnresectable Extrahepatic Bile Duct Carcinoma | Recurrent Cholangiocarcinoma | Non-Resectable Cholangiocarcinoma | Stage III Intrahepatic Cholangiocarcinoma | Stage IIIA Hilar Cholangiocarcinoma | Stage IIIB Hilar Cholangiocarcinoma | Stage IVA Hilar Cholangiocarcinoma | Stage IVA Intrahepatic Cholangiocarcinoma and other conditionsUnited States
-
Yonsei UniversityUnknownKlatskin Tumor | Biliary Obstructive Disease Such as Choledocholithiasis | Benign Biliary Stricture | Peri-ampullary Cancer | Bile Duct Cancer ResectableKorea, Republic of
-
Instituto Ecuatoriano de Enfermedades DigestivasUniversity of Sao Paulo; Universitair Ziekenhuis Brussel; The Methodist Hospital... and other collaboratorsCompletedCommon Bile Duct Neoplasms | Non-Neoplastic Bile Duct DisorderUnited States, Ecuador, Belgium, Brazil
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingLiver and Intrahepatic Bile Duct CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedHilar Cholangiocarcinoma | Advanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Liver Carcinoma | Recurrent Adult Liver Carcinoma | Recurrent Gallbladder Carcinoma | Stage IV Distal Bile Duct Cancer | Unresectable Extrahepatic Bile Duct Carcinoma | Stage II Gallbladder Cancer | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterCancer Prevention Research Institute of TexasActive, not recruitingLiver and Intrahepatic Bile Duct CarcinomaUnited States
-
Centre Hospitalier Universitaire DijonTerminatedNon-resectable Metastatic Cancer of the Lung | Non-resectable Metastatic Cancer of the Colon | Non-resectable Metastatic Cancer of the Rectosigmoid Junction | Non-resectable Metastatic Cancer of the Stomach | Non-resectable Metastatic Cancer of the Bile Duct | Non-resectable Metastatic Cancer... and other conditionsFrance
Clinical Trials on Temoporfin
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Quintiles, Inc.Unknown
-
Roswell Park Cancer InstituteNational Institutes of Health (NIH); Biolitec Pharma Ltd.WithdrawnTongue Cancer | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Oral Cavity | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Oropharynx and other conditions
-
Chinese University of Hong KongCompletedCholangiocarcinoma | Klatskin Tumor | TumorHong Kong
-
University of ArkansasWithdrawnCarcinoma, Non-Small-Cell-LungUnited States
-
University of ArkansasErasmus Medical Center; The Netherlands Cancer Institute; Biolitec Pharma Ltd.TerminatedSquamous Cell Carcinoma of the Head and NeckUnited States
-
Roswell Park Cancer InstituteCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung CarcinomaUnited States