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

Phase 2

• Conditions: Non-curative Resectable Bile Duct Carcinoma
• Interventions: Drug: Temoporfin

• Registration Number: NCT01016002
• Lead Sponsor: University of Salzburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Status Verified: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Last Update Submitted: 2009-11-16
• Study First Posted: 2009-11-18
• Last Update Posted: 2009-11-18
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Temoporfin	-

Primary Outcome Measures

Name	Time	Method
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT	post treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival time, overall survival time	Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Toxicity using WHO criteria and criteria for local toxicity in the biliary system	Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention

Trial Locations

Locations (2)

Internal Medicine Dept., University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Department of Internal Medicine I, Paracelsus Medical University Salzburg; 🇦🇹 Salzburg, Austria