Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Phase 2

Withdrawn

• Conditions: Cholangiocarcinoma
• Interventions: Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

• Registration Number: NCT00713687
• Lead Sponsor: Technical University of Munich

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 Timeline

• Status Verified: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Study Start: 2008-08
• Study Completion: 2011-12
• Last Update Submitted: 2012-08-09
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)	Treatment by combination of photodynamic therapy and chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression free survival 6 months after study start	6 months after study start

Secondary Outcome Measures

Name	Time	Method
Progression free survival 12 months after study start Progression free interval Overall survival Life quality	Until 12 months after study start

Trial Locations

Locations (1)

Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22; 🇩🇪 Munich, Germany