Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

University of Salzburg

Status and phase

Unknown

Phase 2

Conditions

Non-curative Resectable Bile Duct Carcinoma

Treatments

Drug: Temoporfin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01016002

EUDRA CT 2005-004866-17

Foscan 1/2005

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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)