RecruitingPhase 3NCT04947059

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

A Prospective Phase III Randomized Clinical Trial Comparing the Effectiveness of Immediate Postoperative Intravesical Instillation With Either Gemcitabine Hydrochloride or Epirubicin Hydrochloride in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)


Sponsor

University of Thessaly

Enrollment

180 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy drugs — gemcitabine and epirubicin — when instilled directly into the bladder immediately after surgery to remove bladder tumors. The goal is to see which drug is more effective at preventing bladder cancer from coming back. **You may be eligible if...** - You have a primary or recurrent (returning) bladder tumor being removed by transurethral resection (a common bladder cancer procedure) - Your blood counts, kidney, and liver levels are within acceptable ranges - You are in generally good health (ECOG performance status 0 or 1) - You have had a urine culture showing no infection - A recent CT scan showed no upper urinary tract tumor **You may NOT be eligible if...** - You have had more than 2 low-grade bladder tumors in the past 18 months - You have had a high-grade bladder tumor in the past 9 months - Your bladder tumor has invaded the muscle layer (muscle-invasive disease) - You have had prior bladder chemotherapy instillations or BCG treatment in the last 6 months - You have cancer in the urethra or upper urinary tract - You have had pelvic radiation or another cancer in the past 5 years - Your tumor resection was incomplete or missing muscle tissue in the sample Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine Hydrochloride combined with continuous saline irrigation

Immediate single intravesical instillation with gemcitabine combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor

DRUGEpirubicin Hydrochloride combined with continuous saline irrigation

Immediate single intravesical instillation with epirubicin combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor


Locations(1)

Urology Department, University of Thessaly, University Hospital of Larissa

Larissa, Larissa/Thessaly, Greece

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NCT04947059


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