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RECRUITING
NCT04947059
PHASE3

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

Sponsor: University of Thessaly

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2021-12-14

Completion Date

2026-10

Last Updated

2022-01-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

Gemcitabine 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

DRUG

Epirubicin 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