Trial | NCT01016002  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    temoporfin ...

  • Study Participants

    35
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.
Study Started
Jan 31
2006
Primary Completion
Dec 31
2011
Anticipated
Last Update
Nov 18
2009
Estimate

Drug Temoporfin

Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan

  • Other names: Foscan, Meso-tetrahydroxyphenyl Chlorin

Intervention Experimental

Criteria 

Inclusion Criteria:

bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:

Bismuth type III or IV ( not resectable with R0-margins )
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)
No Results Posted