Non Muscle Invasive Bladder Cancer
Conditions
Brief summary
The goal of this clinical trial is to compare the efficacy and safety of two Bacillus Calmette-Guérin (BCG) substrains (RIVM and Russian) in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) in adult patients. The main questions it aims to answer are: * Is there a significant difference in recurrence-free survival (RFS) between the BCG RIVM and BCG Russian substrains? * Is there a significant difference in progression-free survival (PFS) between the two substrains? * Are there notable differences in the incidence of treatment-related adverse events between the strains? Researchers will compare patients treated with BCG RIVM to patients treated with BCG Russian to determine whether one substrain offers superior clinical outcomes in terms of recurrence, progression, and adverse events. Participants will: Undergo transurethral resection of bladder tumor (TURBT) prior to initiating therapy. Be randomly assigned to receive either BCG RIVM or BCG Russian intravesical therapy. Receive an induction course of six weekly instillations of the assigned BCG substrain. Receive maintenance therapy at regular intervals (3, 6, 12, 18, 24, 30, and 36 months) based on risk classification. Undergo regular follow-up with cystoscopy and urine cytology to assess recurrence, progression, and adverse events.
Interventions
In this study we compared the efficacy and side effects of two different strains of BCG (RIVM and RUSSIAN strains) in non muscle invasive bladder cancer patients
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This randomized, prospective trial included 125 patients with intermediate-, high-, and very high-risk non muscle invasive bladder cancer. Patients were randomized into two groups to receive either the BCG RIVM or BCG Russian substrain following transurethral resection of bladder tumor (TURBT).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* age ≥18 years, * histopathologically confirmed NMIBC (stages Ta, T1, or CIS), * classification as intermediate, high, or very high risk (who either refused or were not suitable candidates for radical cystectomy), * no prior BCG therapy, * no evidence of upper urinary tract carcinoma or distant metastases and * a minimum follow-up period of 12 months.
Exclusion criteria
* patients who did not receive adequate BCG therapy (defined as receiving fewer than 5 of the 6 induction doses or fewer than 2 of the 3 maintenance doses), * patients with a follow-up period of less than 12 months and * patients who received multiple BCG strains during the follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence free survival | Through study completion, up to 4 years |
| progression free survival | Through study completion, up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| side effects of the treatment | At each BCG instillation and follow-up visit, up to 4 years |
Countries
Turkey (Türkiye)
Outcome results
None listed