Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma
18 Years
90 Years
Both
Cholangiocarcinoma
Trial Information
Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma
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.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival 6 months after study start
Outcome Time Frame:
6 months after study start
Principal Investigator
Matthias Ebert, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Head of the gastroenterological department of the Klinikum rechts der Isar
Authority:
Germany: Ethics Commission
Study ID:
GEM-658-EBE-0024-I
NCT ID:
NCT00713687
Start Date:
August 2008
Completion Date:
December 2011
Related Keywords:
- Cholangiocarcinoma
- photodynamic therapy
- PDT
- gemcitabine
- oxaliplatin
- cholangiocarcinoma
- Cholangiocarcinoma
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