BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer (NCT06462001) | Clinical Trial Compass
Active — Not RecruitingPhase 3
BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
United Kingdom500 participantsStarted 2020-12-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females with confirmed high grade pTa or stage pT1 (any grade) non-muscle invasive bladder cancer on initial or re-resection histology (concurrent carcinoma in situ is allowed).
✓. Age ≥ 18 yrs
✓. No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may either be the initial TURBT at which the primary tumour was completely resected, or a planned second cystoscopy and/ or re-resection done within 8 weeks of the initial TURBT.
✓. ECOG Performance Status of 0-2
✓. Adequate bone marrow, renal and liver function confirmed by pre-randomisation blood tests.
✓. Study treatment both planned and able to start within 4 weeks of randomisation
✓. Is willing to complete HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
✓. Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
✕. Contraindications or hypersensitivity to investigational products, BCG and MM
✕. Prior treatment with any other intravesical agent including BCG or MM (excludes single doses given post TURBT)
✕. Current or past transitional cell carcinoma (TCC) of the upper urinary tract
✕. Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
✕. Bladder dysfunction precluding intravesical therapy e.g. Severe urinary incontinence or overactive or spastic bladder
✕. Life expectancy \< 3 months
✕. Congenital or acquired immune deficiencies, whether due to a concurrent disease (e.g. acquired immune deficiency syndrome (AIDS), leukaemia, lymphoma) or immunosuppressive therapy (e.g. corticosteroids), or cancer therapy (cytotoxic drugs, radiation)