drugset / Trial / NCT02948543
Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer
Phase 3
Unknown
501 enrolled
University of Sydney
Australian and New Zealand Urogenital and Prostate Cancer Trials Group · collabCancer Australia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Open label, randomised phase 3 trial of the addition of Mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to compare disease-free survival between treatment arms: BCG alone versus Mitomycin in addition to BCG.
Timeline
- Start
- 2013-07
- Primary completion
- 2024-12
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacillus of Calmette-Guerin (BCG) | Unknown | 81 mg | Other |
| Subject | Mitomycin C | Other / unclassified | 40 mg | Intravenous |