The Bladder Instillation Comparison Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Urinary Bladder Neoplasms

Intervention / Treatment
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* Drug: Mitomycin C
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sign an informed consent for the study be scheduled for a TURBT for suspected non-muscle invasive bladder tumor. Exclusion Criteria: patients unable to consent for themselves individuals under 18 years old pregnant women prisoners patients with known allergy or intolerance to the mitomycin C or Gemcitabine any other sound medical, psychiatric and/or social reason as determined by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitomycin C<br>Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. | Drug: Mitomycin C<br>* Cancer chemotherapeutic agent<br>* Other names: Mutamycin;|
| Active Comparator: Gemcitabine<br>Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. | Drug: Gemcitabine<br>* Cancer chemotherapeutic agent<br>* Other names: Gemzar, Novaplus;|
| No Intervention: No intervention<br>Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 | 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. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Bladder Stones/Dystrophic Calcification | 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 | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder tumors, urinary tumors, non-muscle invasive bladder tumors, NMIBC