34
Participants
Start Date
February 21, 2023
Primary Completion Date
October 31, 2025
Study Completion Date
October 31, 2027
Epirubicin
"In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times.~Epirubicin is also the default drug, in case of failure of drug prediction in the in-vitro drug screen in PDO.~Epirubicin will be used as a concentrate for injection/instillation 2 mg/ml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg/ml of Epirubicin."
Mitomycin
"In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times.~Mitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions"
Gemcitabine
"In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times.~Gemcitabine will be used as 2000 mg/50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg/50ml used for instillation."
Docetaxel
"In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times.~Docetaxel will be used as 140mg/7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg/ml by a total volume of the instillation solution of 50,7."
RECRUITING
Spitalzentrum Biel/Bienne, Biel
University of Bern
OTHER
Hospital Centre Biel/Bienne
OTHER
Roland Seiler-Blarer
OTHER