Clinical Trials Directory

Trials / Completed

CompletedNCT02695771

The Bladder Instillation Comparison Study

A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
101 (actual)
Sponsor
Corewell Health West · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

Detailed description

This study will compare standard of care treatment for patients with non-muscle invasive bladder cancer (NMIBC). Patients will be randomized to one of three arms, Mitomycin C, Gemcitabine or no additional treatment immediately following TURBT in the operating suite. All treatment, surgical procedures and follow up care will be conducted according to standard of care treatment.

Conditions

Interventions

TypeNameDescription
DRUGMitomycin CCancer chemotherapeutic agent
DRUGGemcitabineCancer chemotherapeutic agent

Timeline

Start date
2016-04-19
Primary completion
2021-10-22
Completion
2021-10-22
First posted
2016-03-01
Last updated
2023-04-21
Results posted
2023-04-21

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02695771. Inclusion in this directory is not an endorsement.