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

Inclusion Criteria1

  • High-risk non-muscle-invasive transitional cell carcinoma of the bladder requiring BCG-therapy, complete resection of bladder tumors by TURBT.

Exclusion Criteria1

  • Muscle-invasive transitional cell carcinoma of the bladder, incomplete resection of tumor by TURBT.

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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