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Clinical trial

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)

ID
Name
2016-030
Description
To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.
Trial arms
Trial start
2016-04-19
Estimated PCD
2021-10-22
Trial end
2021-10-22
Status
Completed
Phase
Early phase I
Treatment
Mitomycin C
Cancer chemotherapeutic agent
Arms:
Mitomycin C
Other names:
Mutamycin
Gemcitabine
Cancer chemotherapeutic agent
Arms:
Gemcitabine
Other names:
Gemzar, Novaplus
Size
101
Primary endpoint
Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
Two years
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 101, 'type': 'ACTUAL'}}
Updated at
2023-04-21

1 organization

1 product

1 drug

1 indication

Organization
Spectrum Health Hospitals
Product
Mitomycin C
Indication
Bladder Cancer
Drug
Gemcitabine