Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

Study Overview
=================
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.

Official Title
-----------------
Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

Conditions
-----------------
Cholangiocarcinoma

Intervention / Treatment
-----------------
* Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment by combination of photodynamic therapy and chemotherapy | Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)<br>* Photodynamic therapy (PDT) after successful drainage: Photosan® 2 mg/kg i.v. 48 hrs before laser activation 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 Iteration of 1. and 2. in case of good compatibility<br>* Other names: No other names;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival 6 months after study start |  | 6 months after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival 12 months after study start Progression free interval Overall survival Life quality |  | Until 12 months after study start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
photodynamic therapy, PDT, gemcitabine, oxaliplatin, cholangiocarcinoma