Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)

Recruiting Phase 3 Interventional Study
Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
180 (estimated)
Sponsor
University of Thessaly · Other
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About This Trial

The natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction of the disease recurrence as well as progression.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Primary urinary bladder tumor * Secondary urinary bladder tumor (recurrence) * Bipolar or monopolar resection * Creat \<2.2mg/dl * 35% \<Hct \<52% * White bloode cells count WBC ≥3000 / μL * 75000 \<PLT \<500000 / μL * Urine culture: negative / sterile * Alkaline phosphatase, …
Contacts

Vasileios Tzortzis, Professor

00302413502811

urologydpt.uth@gmail.com

CONTACT

Lampros Mitrakas, Consultant

00302413501325

lamprosmit@gmail.com

CONTACT