Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Technical University of Munich

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22

Munich, Germany

Outcomes

Primary Outcomes

Progression free survival 6 months after study start

Time frame: 6 months after study start

Secondary Outcomes

Progression free survival 12 months after study start Progression free interval Overall survival Life quality

Time frame: Until 12 months after study start

Data from ClinicalTrials.gov

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