BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
NCT Number: NCT06462001
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Transitional Cell Carcinoma|Transurethral Resection
Interventions: BIOLOGICAL: Bacillus Calmette-Guerin Vaccine Intravesical|DRUG: Mitomycin
Sponsor: Nottingham University Hospitals NHS Trust
Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group|University of Sydney
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-12-10
Completion Date: 2026-12-01
Locations: Nottingham University Hospitals, Nottingham, NG51PB, United Kingdom

Summary:
Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still develop recurrent transitional cell carcinoma (TCC) despite optimal therapy with adjuvant intravesical BCG. Our meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin (MM) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.

Primary Outcome Measures: Disease free survival, Death, disease free survival, or evidence of transitional cell carcinoma (TCC), 5 years follow up
Secondary Outcome Measures: Activity, Clear cystoscopy at 3 months, 3 months|Time to Recurrence, Recurrence of TCC bladder, 5 years follow up|Time to Progression, Recurrence of Higher Grade or Stage, 5 years follow up|Safety and adverse events, Adverse Events Graded According to CTC AE V4.03, During treatment phase of the trial (typically 12 months)|Health-Related Quality of Life, QLQ-BLS24. Individual internationally-validated (but subjective) symptom score questionnaire that gives an overall QOL assesment, that can be tracked throughout follow up. They do not use SI units of measurement., 5 years follow up|Health-Related Quality of Life, QLQ-C30. Individual internationally-validated (but subjective) symptom score questionnaire that gives an overall QOL assesment, that can be tracked throughout follow up. They do not use SI units of measurement., 5 years follow up|Health-Related Quality of Life, I-PSS. Individual internationally-validated (but subjective) symptom score questionnaire that gives an overall QOL assesment, that can be tracked throughout follow up. They do not use SI units of measurement., 5 years follow up|Overall Survival Time, Death from any Cause, 5 years follow up|Feasibility as a future standard of care, Compliance with intravesical therapy, measured in percent (%) of planned intravesical therapies actually given, During treatment phase of the trial, typically 1 year|Marginal Resource Use, Number of GP visits, Number of outpatient and emergency department visits, number of inpatient admissions and number of days admitted, 5 years follow up
Other Outcome Measures: To consider future exploratory biomarker studies as potential prognostic biomarkers or predictive biomarkers of treatment, Future (as yet unidentified) biomarker expression could be measured and then statistical association of those biomarkers with primary outcome meaures assessed., 5 years follow up