Clinical Trial: Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

Brief Summary: In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.

Detailed Summary: Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.
Sponsor: Technische Universität München

Current Primary Outcome: Progression free survival 6 months after study start [ Time Frame: 6 months after study start ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Progression free survival 12 months after study start Progression free interval Overall survival Life quality [ Time Frame: Until 12 months after study start ]

Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: July 7, 2008
Date Started: August 2008
Date Completion: December 2011
Last Updated: August 9, 2012
Last Verified: July 2008