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

NCT03062059 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2022-04-14

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • Chong Kun Dang Pharmaceutical Corp.

    collaborator INDUSTRY

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Seok Ho Kang, M.D. · Korea universitiy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062059 on ClinicalTrials.gov