drugset / Trial / NCT02214602

Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer

NCT02214602 ↗

Phase 4 Completed 240 enrolled Mansoura University
RandomizedParallel-groupSingle-blindPrevention

Summary

The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).

Timeline

Start
2014-07
Primary completion
2017-04
Completion
2017-05

Outcome

Missed primary endpoint

paper There was no statistically significant difference between the 2 groups regarding recurrence rate (27.1% vs. 26.2%) PMID 30448030 ↗

paper Recurrences and progression-free survival were comparable between the 2 groups (Log-rank P = 0.88 and 0.47, respectively). PMID 30448030 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Epirubicin Small molecule 50 mg Other