Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

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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