CompletedPhase 3ACTRN12611000204943

Intravesical instillation therapy for high-risk non-muscle-invasive transitional cell carcinoma of the bladder: Does the strain of Bacillus Calmette-Guerin (BCG) matter?

Assessment of intravesical instillation therapy with two different strains of Bacillus Calmette-Guerin (BCG) in patients with high-risk non-muscle-invasive transitional cell carcinoma of the bladder in terms of recurrence and survival.


Sponsor

Department of Urology, Inselspital Bern

Enrollment

149 participants

Start Date

Aug 6, 1986

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares different strains of BCG (a treatment given directly into the bladder) for people with high-risk, early-stage bladder cancer that has not spread into the muscle wall. Participants must be adults whose bladder tumors have been completely removed by surgery before starting BCG treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

After completed transurethral resection of a bladder tumor (TURBT), patients diagnosed with high-risk non-muscle-invasive transitional cell carcinoma of the bladder, which qualify for a maintenance BC

After completed transurethral resection of a bladder tumor (TURBT), patients diagnosed with high-risk non-muscle-invasive transitional cell carcinoma of the bladder, which qualify for a maintenance BCG therapy, are prospectively included in the trial. Patients are randomized into 2 groups: One group will use the strain BCG-Connaught (dose 1.5-5x10E8 CFU, intravesical), the other group the strain BCG-Tice (dose 5x10E8 CFU, intravesical) for the bladder instillation. Within 2 weeks after the TURBT the BCG instillation therapy is begun. A total of 6 bladder instillations are performed in weekly intervals. For the bladder instillation BCG is injected into the bladder by a single use urethral catheter. Intravesical therapy duration is 2 hours. Regular follow-up controls with cystoscopy and urine cytology are performed every 3 months during the first 3 years and then every 6 months until at least 5 years postoperatively.


Locations(1)

Switzerland

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ACTRN12611000204943