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-DE
- Lead Sponsor
- Dept Medicine I, Paracelsus Med. Univ.Landeskrankenanstalten Salzburg / SALK
- 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 Foscan (temoporfiin) photodynamic therapy tumorocidal penetration greater than 8mm. To assess efficacy and safety of Foscan (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