Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Collaborator: Münchner Studienzentrum
• Treatments: Gemcitabine; Oxaliplatin

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