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Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study

NCT04398368 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-08-08

Study results available
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Summary

This phase II trial studies how well gemcitabine works in preventing urothelial cancer from coming back within the bladder (intravesical recurrence) in patients with upper urinary tract urothelial cancer undergoing radical nephroureterectomy. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Instilling gemcitabine into the bladder during surgery, may reduce the chance of recurrence of upper urinary tract urothelial cancer.

Conditions

  • Stage 0a Renal Pelvis and Ureter Cancer AJCC v8
  • Stage 0a Renal Pelvis Cancer AJCC v8
  • Stage 0a Ureter Cancer AJCC v8
  • Stage 0is Renal Pelvis and Ureter Cancer AJCC v8
  • Stage 0is Renal Pelvis Cancer AJCC v8
  • Stage 0is Ureter Cancer AJCC v8
  • Stage I Renal Pelvis and Ureter Cancer AJCC v8
  • Stage I Renal Pelvis Cancer AJCC v8
  • Stage I Ureter Cancer AJCC v8
  • Stage II Renal Pelvis and Ureter Cancer AJCC v8
  • Stage II Renal Pelvis Cancer AJCC v8
  • Stage II Ureter Cancer AJCC v8
  • Stage III Renal Pelvis and Ureter Cancer AJCC v8
  • Stage III Renal Pelvis Cancer AJCC v8
  • Stage III Ureter Cancer AJCC v8
  • Stage IV Renal Pelvis and Ureter Cancer AJCC v8
  • Stage IV Renal Pelvis Cancer AJCC v8
  • Stage IV Ureter Cancer AJCC v8

Interventions

DRUG

Gemcitabine Hydrochloride

Given intravesically

Sponsors & Collaborators

Principal Investigators

  • Stephen A Boorjian · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2023-02-02
Completion
2023-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04398368 on ClinicalTrials.gov