Precise Neoadjuvant Chemoresection of Low Grade NMIBC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern
About this trial
Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial. The investigators aim to use drug screens in PDOs to guide neoadjuvant intravesical instillation therapy with either Epirubicin, Mitomycin C, Gemcitabine or Docetaxel to achieve chemoresection NMIBC.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Signed Informed Consent Form
ECOG performance status of 0 or 1
Previous history of low risk non-muscle invasive urothelial carcino-ma of the bladder with recurrent papillary tumor and negative urine cytology or Primary solitary papillary tumor, <3cm and negative urine cytology
Disqualifiers
Known previous high grade and/or intermediate or high risk non-muscle invasive bladder cancer
Anticoagulation other than acetylsalicylic acid
Previous Intravesical biological/immuno- (BCG) therapy
Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
Trial design
Treatments tested in this trial
- Epirubicin
- Mitomycin
- Gemcitabine
- Docetaxel
Treatment groups
28 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Bern
Lead sponsor
Spitalzentrum Biel
Collaborator
Source ClinicalTrials.gov