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A Phase III Study of Mitomycin C versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer
[Protocol 09-118]
- Full 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
- Purpose :
Mitomycin C and Bacillus Calmette-Guerin (BCG) are two therapies that have been used for many years to treat bladder cancer when put directly into the bladder (intravesical treatment). BCG has been studied more often than mitomycin C. A long schedule of BCG has been shown to be more effective than a short schedule of mitomycin C, but with more side effects.
A recent study showed that a new dose of mitomycin C is better than the old standard dose. Since the side effects of mitomycin C occur less often, it is important to learn whether the two drugs are equally effective for treating bladder cancer and preventing recurrence.
The purpose of this study is to compare mitomycin C and BCG intravesical therapy when given for the same length of time in patients with non-muscle-invasive bladder cancer. Patients will be randomly assigned to receive one treatment or the other.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of intermediate-risk non-muscle-invasive bladder cancer.
- Patients may not currently be treated or be scheduled to be treated with surgery, radiation therapy, or chemotherapy during the study.
- Patients may not have had intravesical therapy within the year prior to entering the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Guido Dalbagni at 646-422-4394.
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