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

January 5, 2025 updated by: Khaled Obaid, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey
        • Ankara University Faculty of Medicine Ibni Sina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 which received BCG RIVM
following transurethral resection of bladder tumor (TURBT), patients in Group 1 received BCG RIVM.
Drug: Bacillus Calmette-Guerin (BCG)
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
Active Comparator: Group 2 which received BCG RUSSIAN
following transurethral resection of bladder tumor (TURBT), patients in Group 2 received BCG RUSSIAN.
Drug: Bacillus Calmette-Guerin (BCG)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence free survival
Time Frame: Through study completion, up to 4 years
Through study completion, up to 4 years
progression free survival
Time Frame: Through study completion, up to 4 years
Through study completion, up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects of the treatment
Time Frame: At each BCG instillation and follow-up visit, up to 4 years
At each BCG instillation and follow-up visit, up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İ10-640-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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