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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT 2005-004866-17 |
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| Name | Class |
|---|---|
| Biolitec Pharma Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temoporfin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT | post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival time, overall survival time | 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 | Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention |
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Inclusion Criteria:
bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frieder Berr, Prof., MD | Contact | (43-) 662-4482 | 2800 | f.berr@salk.at |
| Lohse A, Prof., MD | Contact | +49-(0)40-4280 | 33 910 | alohse@uke-uni-hamburg.de |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine I, Paracelsus Medical University Salzburg | Recruiting | Salzburg | State of Salzburg | 5020 | Austria |
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| ID | Term |
|---|---|
| C072269 | temoporfin |
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| Principal Investigator |
| Internal Medicine Dept., University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
|