Status:
WITHDRAWN
Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Münchner Studienzentrum
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 rand...
Detailed Description
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 we...
Eligibility Criteria
Inclusion
- Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in \>= 2 diagnostic methods
- Bile duct stenoses which are technically successful treated with biliary drainage
- Irresectability/inoperability
- Karnofsky-Index \>= 60%
- Age \>= 18
- Written consent
- Before chemotherapy:
- Bilirubin \<= 5 mg/dl
- GOT/GPT \< 5x upper standard
- Creatinine \< 2x upper standard
- Thrombocytes \> 100 G/l
- Neutrophils \> 2,00 G/l
- Haemoglobin \> 9 g/dl
- No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)
Exclusion
- Implantation of a metal stent in the bile duct
- Previous PDT or chemotherapy
- Neoplasia
- Porphyria
- Pregnant or breastfeeding women
- Women of childbearing age and potent men who are not using highly effective contraceptives
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00713687
Start Date
August 1 2008
End Date
December 1 2011
Last Update
August 10 2012
Active Locations (1)
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1
Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22
Munich, Germany, 81675