The Bladder Instillation Comparison Study

Phase 3

Completed

• Conditions: Urinary Bladder Neoplasms
• Interventions: Drug: Mitomycin C; Drug: Gemcitabine

• Registration Number: NCT02695771
• Lead Sponsor: Spectrum Health Hospitals

Brief 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.

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Study Start: 2016-04-19
• Primary Completion: 2021-10-22
• Study Completion: 2021-10-22
• Results First Submitted: 2023-02-07
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Results First Posted: 2023-04-21
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. sign an informed consent for the study
2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion Criteria

1. patients unable to consent for themselves
2. individuals under 18 years old
3. pregnant women
4. prisoners
5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine
6. any other sound medical, psychiatric and/or social reason as determined by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitomycin C	Mitomycin C	Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine	Gemcitabine	Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

Primary Outcome Measures

Name	Time	Method
Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03	Two years	The NCI CTCAE Version 4.03 grades adverse events as follows: grade 3 include severe but non-life-threatening consequences that result in hospitalization and/or interventions, including elective radiologic or operative interventions; grade 4 events include life-threatening consequences, such as those requiring urgent reoperation; and grade 5 events result in treatment-related death.

Secondary Outcome Measures

Name	Time	Method
Freedom From Bladder Stones/Dystrophic Calcification	Two years	The secondary endpoint for this study will be the number of subjects who did not experience dystrophic calcification or bladder calculi measured by the number of patients with Grade 3 through Grade 5 Adverse Events that are related to study arm, graded according to NCI CTCAE Version 4.03.Version 4.03

Trial Locations

Locations (3)

Spectrum Health Medical Group-Division of Urology-LHCP; 🇺🇸 Grand Rapids, Michigan, United States

Spectrum Health Medical Group-Division of Urology; 🇺🇸 Grand Rapids, Michigan, United States

Urologic Consultants P.C.; 🇺🇸 Grand Rapids, Michigan, United States