The Bladder Instillation Comparison Study (BIC)

Spectrum Health Hospitals

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder Neoplasms

Treatments: Drug: Gemcitabine; Drug: Mitomycin C

Study type: Interventional

Funder types: Other

Identifiers

NCT02695771

2016-030

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

Mitomycin C

Experimental group

Description:

Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

Treatment:

Drug: Mitomycin C

Gemcitabine

Active Comparator group

Description:

Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

Treatment:

Drug: Gemcitabine

No intervention

No Intervention group

Description:

Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.