Bladder Cancer Clinical Trial
Official title:
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients: A Randomized Phase III Non-inferiority Trial
The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and
Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will
get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get
both.
The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the
diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even
after the doctor removes the tumors, the cancer can return. In this case, the doctor will
put medicine into the bladder to destroy cancer cell. This is called intravesical therapy.
The two most commonly used drugs for this purpose are MMC and BCG.
Both drugs have been studied for many years. They both show good results when compared to
other treatments. They have not been studied using the schedule that will be used in the
study. The doctor does not know if these two drugs are equally effective in treating the
cancer and preventing recurrence.
BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG
is better than a short schedule of MMC. They have also shown that the side effects of BCG
are more intense than with MMC. A recent study showed that a new dose of MMC is better than
the old standard dose. Since the side effects of MMC occur less often, it is important to
learn whether the two drugs are equally effective. That could help us decide between the
treatments. In this study, the doctor will compare MMC and BCG when given for the same
amount of time. The doctor hopes the study will tell us which drug is more effective in
preventing the return of the cancer.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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