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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Non Muscle Invasive Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 which received BCG RIVM

following transurethral resection of bladder tumor (TURBT), patients in Group 1 received BCG RIVM.

Group Type ACTIVE_COMPARATOR

Bacillus Calmette-Guerin (BCG)

Intervention Type 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

Group 2 which received BCG RUSSIAN

following transurethral resection of bladder tumor (TURBT), patients in Group 2 received BCG RUSSIAN.

Group Type ACTIVE_COMPARATOR

Bacillus Calmette-Guerin (BCG)

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No