NCT03062059

The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence

The Effectiveness and Safety of Intravesical Gemcitabine Instillation During Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy in Upper Urinary Tract Urothelial Carcinoma: Prospective, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.

Detailed description

Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Outcome Measures: Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Secondary Outcome Measures: Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Safety of intravesical 2000mg/52.6ml gemcitabine instillation.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Intravesical 2000mg/52.6ml gemcitabine instillation	Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma
OTHER	Normal saline	Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-02-23
• Last updated: 2022-04-14

Locations

5 sites across 1 country: South Korea