An Open-label, single arm Phase II Trial of Photodynamic Therapy using Foscan for non-curatively-resectable bile duct carcinoma - Foscan-PDT-protocol for BDC
- Conditions
- onresectable hilar or extrahepatic bile duct carcinoma in clinical stage MO ( without liver or peritoneal metastases according to clinical or surgical staging)
- Registration Number
- EUCTR2005-004866-17-AT
- Lead Sponsor
- Paracelsus Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
a) Bismuth type 111 or IV ( not resectable with RO-margins ),
b) 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 2 30%)
* age> 19 years
* access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
* informed written consent for PDT.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
* 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 )
* accompaning/complicating disease with very poor prognosis (expected survival < 6 weeks),
* proven advanced peritoneal carcinomatosis (PET scan imaging, ascites positive for tumor cells)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess efficacy and safety of FoscanB (temoporfiin) photodynamic therapy in the treatment of locally advanced hilar or extrahepatic bile duct carcinoma without distant metastases.;Secondary Objective: - Progression-free survival time, overall survival time<br>- Rate of systemic response (RECIST criteria / EORTC)(37).<br>- Toxicity using WHO criteria and criteria for local toxicity in the biliary system;Primary end point(s): Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
- Secondary Outcome Measures
Name Time Method