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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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
Department of Internal Medicine I, Paracelsus Medical University Salzburg
Salzburg, State of Salzburg, Austria
RECRUITINGInternal Medicine Dept., University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
RECRUITINGRate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
Time frame: post treatment
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
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
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