cancer of the biliary tract cholangiocarcinoma
Conditions
Interventions
Open-label Phase-II trial of Foscan* (temoporfin) photodynamic therapy in
patients with non-resectable perihilar bile duct carcinoma in clinical stage M0
(without liver or peritoneal metastases acco
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of local response and depth of tumoricidal tissue penetration of Foscan*- PDT. | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Progression-free survival time, overall survival time; (ii) rate of systemic response; (iii) Toxicity using WHO criteria and criteria for local toxicity in the biliary system. | — |
Countries
Netherlands
Outcome results
None listed