Not Yet RecruitingPhase 2

Precise Neoadjuvant Chemoresection of Low Grade NMIBC

Switzerland28 participantsStarted 2024-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Pathological response

Timeframe: 15 weeks

Trial details

NCT IDNCT06227065

SponsorUniversity of Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Roland Seiler, Prof.

+41 32 324 32 06 urologie@szb-chb.ch

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