Clinical Trial: Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
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 Summary:
Sponsor: University of Salzburg
Current Primary Outcome: Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT [ Time Frame: post treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression-free survival time, overall survival time [ Time Frame: 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 [ Time Frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention ]
Original Secondary Outcome: Same as current
Information By: University of Salzburg
Dates:
Date Received: November 16, 2009
Date Started: January 2006
Date Completion:
Last Updated: November 16, 2009
Last Verified: November 2009
