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Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

NCT00713687 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-08-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

1. Photodynamic therapy (PDT) after successful drainage: Photosan® 2 mg/kg i.v. 48 hrs before laser activation 2. 9 cycles of GemOx chemotherapy (start 4 weeks after PDT): * Gemcitabine 1000 mg/m² 100 min infusion on day 1 of chemotherapy * Oxaliplatin 100 mg/m² 2h infusion on day 2 of chemotherapy * iteration every 14 days * afterwards 4 weeks intermission 3. Iteration of 1. and 2. in case of good compatibility

Sponsors & Collaborators

  • Münchner Studienzentrum

    collaborator UNKNOWN

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Matthias Ebert, Prof. Dr. · Head of the gastroenterological department of the Klinikum rechts der Isar

  • Roland M. Schmid, Prof. Dr. · Head of the gastroenterological department of the Klinikum rechts der Isar

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00713687 on ClinicalTrials.gov