Clinical trial NCT01016002: Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
Official title: A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-curative Resectable Bile Duct Carcinoma
Lead sponsor: University of Salzburg
Sponsor class: OTHER
Collaborators: name: Biolitec Pharma Ltd.
First posted: 2009-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
timeFrame: post treatment
Secondary outcomes:
measure: Progression-free survival time, overall survival time
timeFrame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
measure: Toxicity using WHO criteria and criteria for local toxicity in the biliary system
timeFrame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Department of Internal Medicine I, Paracelsus Medical University Salzburg
city: Hamburg
country: Germany
facility: Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
name: Frieder Berr, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
name: Lohse A, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: