Brief Title
Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma
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 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 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival 6 months after study start
Secondary Outcome
Progression free survival 12 months after study start Progression free interval Overall survival Life quality
Condition
Cholangiocarcinoma
Intervention
Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)
Study Arms / Comparison Groups
1
Description: Treatment by combination of photodynamic therapy and chemotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
August 2008
Completion Date
December 2011
Eligibility Criteria
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
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Matthias Ebert, Prof. Dr., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00713687
Organization ID
GEM-658-EBE-0024-I
Secondary IDs
EudraCT-Nr.: 2008-001560-37
Study Sponsor
Technical University of Munich
Collaborators
Münchner Studienzentrum
Study Sponsor
Matthias Ebert, Prof. Dr., Principal Investigator, Head of the gastroenterological department of the Klinikum rechts der Isar
Verification Date
July 2008