Non-curative Resectable Bile Duct Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGTemoporfin
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
Sponsors
Biolitec Pharma Ltd.
University of Salzburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension: 1. Bismuth type III or IV ( not resectable with R0-margins ) 2. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT | post treatment |
Secondary
| Measure | 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 |
Countries
Austria, Germany
Contacts
Primary ContactFrieder Berr, Prof., MD
Backup ContactLohse A, Prof., MD
Outcome results
None listed