Clinical trial NCT06767982: Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)
Official title: A Randomized Prospective Trial Comparing Bacillus Calmette-Guerin (BCG) RIVM and Russian Strains in Non-Muscle Invasive Bladder Cancer: Efficacy and Side Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Muscle Invasive Bladder Cancer
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: recurrence free survival
timeFrame: Through study completion, up to 4 years
measure: progression free survival
timeFrame: Through study completion, up to 4 years
Secondary outcomes:
measure: side effects of the treatment
timeFrame: At each BCG instillation and follow-up visit, up to 4 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine Ibni Sina Hospital
state: Altindag
Study officials:
References:
citation: Unda-Urzaiz M, Cozar-Olmos JM, Minana-Lopez B, Camarero-Jimenez J, Brugarolas-Rossello X, Zubiaur-Libano C, Ribal-Caparros MJ, Suarez-Charneco AJ, Rodriguez-Tesedo V, Chantada-Abal V, Ruiz-de-Leon C, Carrillo-George C, Carballido-Rodriguez J, Villacampa-Auba F; en representacion del Grupo Espanol del Registro de Cepas de BCG. Safety and efficacy of various strains of bacille Calmette-Guerin in the treatment of bladder tumours in standard clinical practice. Actas Urol Esp (Engl Ed). 2018 May;42(4):238-248. doi: 10.1016/j.acuro.2017.10.003. Epub 2017 Dec 30. English, Spanish.
citation: Niwa N, Kikuchi E, Matsumoto K, Kosaka T, Mizuno R, Oya M. Does switching the bacillus Calmette-Guerin strain affect clinical outcome in patients with recurrent non-muscle-invasive bladder cancer after initial bacillus Calmette-Guerin therapy? Urol Oncol. 2018 Jun;36(6):306.e1-306.e8. doi: 10.1016/j.urolonc.2018.02.005. Epub 2018 Mar 9.
citation: Krajewski W, Matuszewski M, Poletajew S, Grzegrzolka J, Zdrojowy R, Kolodziej A. Are There Differences in Toxicity and Efficacy between Various Bacillus Calmette-Guerin Strains in Bladder Cancer Patients? Analysis of 844 Patients. Urol Int. 2018;101(3):277-284. doi: 10.1159/000492722. Epub 2018 Sep 18.
citation: Del Giudice F, Busetto GM, Gross MS, Maggi M, Sciarra A, Salciccia S, Ferro M, Sperduti I, Flammia S, Canale V, Chung BI, Conti SL, Eisenberg ML, Skinner EC, De Berardinis E. Efficacy of three BCG strains (Connaught, TICE and RIVM) with or without secondary resection (re-TUR) for intermediate/high-risk non-muscle-invasive bladder cancers: results from a retrospective single-institution cohort analysis. J Cancer Res Clin Oncol. 2021 Oct;147(10):3073-3080. doi: 10.1007/s00432-021-03571-0. Epub 2021 Mar 6.
citation: Huang Z, Liu H, Wang Y, Zhang C, Xu T. Determining optimal maintenance schedules for adjuvant intravesical bacillus Calmette-Guerin immunotherapy in non-muscle-invasive bladder cancer: a systematic review and network meta-analysis. Curr Med Res Opin. 2017 Aug;33(8):1379-1387. doi: 10.1080/03007995.2017.1326889. Epub 2017 Jun 6.