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A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma


Phase 2
19 Years
N/A
Open (Enrolling)
Both
Non-curative Resectable Bile Duct Carcinoma

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Trial Information

A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT

Outcome Time Frame:

post treatment

Safety Issue:

No

Principal Investigator

Frieder Berr, Prof., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria

Authority:

Austria : Federal Ministry for Labour, Health, and Social Affairs

Study ID:

Foscan 1/2005

NCT ID:

NCT01016002

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Non-curative Resectable Bile Duct Carcinoma
  • Carcinoma
  • Bile Duct Neoplasms
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

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