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Adding mitomycin C to Bacillus of Calmette-Guerin (BCG) as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer: a randomised phase 3 trial.
Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)
The purpose of this study is to determine the effect of adding mitomycin C (a chemotherapy drug) to best current treatment in patients with high-risk non-muscle invasive bladder cancer.
Who is it for?
You may be eligible to join this study if you are at least 18 years of age and have been diagnosed with non-muscle invasive bladder cancer. You should have undergone transurethral resection of the bladder tumour (TURBT) within 8 weeks prior to enrolment with no visible disease remaining.
Non-muscle invasive bladder cancer is common, causes substantial suffering, and requires radical removal or irradiation of the bladder within 5 years in over 30% of people with high risk tumours despite best current treatment. Recent preliminary studies show promising results from adding mitomycin C, a chemotherapy drug, to best current treatment with BCG.
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard treatment. This involves direct instillation of the drug, Bacillus of Calmette-Guerin (BCG) into the bladder weekly for 6 weeks, and then monthly for 10 months. Participants in the other group with receive BCG and the chemotherapy drug, mitomycin C, via instillation into the bladder weekly for 9 weeks, and then monthly for 9 months.
Participants will be regularly assessed for up to 5 years in order to determine the effects of adding mitomycin C on cure rates, survival, side effects, and quality of life.