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NCT Number: NCT06767982

Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)

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.

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Key information

Conditions

Non Muscle Invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University Faculty of Medicine Ibni Sina Hospital

Ankara, Altindag, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bacillus Calmette-Guerin (BCG)

Drug

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

Primary outcomes

  1. recurrence free survival

    Time frame: Through study completion, up to 4 years

  2. progression free survival

    Time frame: Through study completion, up to 4 years

Secondary outcomes

  1. side effects of the treatment

    Time frame: At each BCG instillation and follow-up visit, up to 4 years

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

A Randomized Prospective Trial Comparing Bacillus Calmette-Guerin (BCG) RIVM and Russian Strains in Non-Muscle Invasive Bladder Cancer: Efficacy and Side Effects

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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