Photodynamic laser therapy using Foscan for non-curatively-resectable bile duct carcinoma

Phase 2

Conditions: cancer of the biliary tract
cholangiocarcinoma
10019815

Registration Number: NL-OMON35016

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

* bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
a) Bismuth type III or IV ( not resectable with R0-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 > 30%)
* age > 19 years
* access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
* informed written consent for PDT (Appendix 3)

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 (or unsafe 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)
* acute destructive bacterial cholangitis (empyema, abscess, cholangitis with confluent liver necrosis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate of local response and depth of tumoricidal tissue penetration of Foscan*-<br /><br>PDT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(i) Progression-free survival time, overall survival time; (ii) rate of<br /><br>systemic response; (iii) Toxicity using WHO criteria and criteria for local<br /><br>toxicity in the biliary system.</p><br>