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Non Muscle Invasive Bladder CancerPhase 4NCT06767982

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

A Phase 4 study testing Bacillus Calmette-Guerin (BCG) in people with Non Muscle Invasive Bladder Cancer, run by Ankara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Non Muscle Invasive Bladder Cancer
What is being tested?
Bacillus Calmette-Guerin (BCG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2019to 31 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara University Faculty of Medicine Ibni Sina Hospital

    Ankara, Altindag

Other trials in Turkey (Türkiye)

About this study

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

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:

Read more
  • 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.

Being tested
Bacillus Calmette-Guerin (BCG)
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06767982
Study groupRoleWhat they receive
Group 1 which received BCG RIVMActive comparatorfollowing transurethral resection of bladder tumor (TURBT), patients in Group 1 received BCG RIVM.
Receives: Drug: Bacillus Calmette-Guerin (BCG)
Group 2 which received BCG RUSSIANActive comparatorfollowing transurethral resection of bladder tumor (TURBT), patients in Group 2 received BCG RUSSIAN.
Receives: Drug: Bacillus Calmette-Guerin (BCG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recurrence free survival

    Measured: Through study completion, up to 4 years

  2. progression free survival

    Measured: Through study completion, up to 4 years

Secondary outcomes (1)

  1. side effects of the treatment

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767982
Sponsor's protocol ID
İ10-640-21
Status last verified
Jan 2025
First submitted
26 Dec 2024
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 29295749

  • 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.

    PubMed 29530465

  • 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.

    PubMed 30227437

  • 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.

    PubMed 33675400

  • 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.

    PubMed 28471272

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bacillus Calmette-Guerin (BCG) in people with Non Muscle Invasive Bladder Cancer, run by Ankara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence free survival (time frame: Through study completion, up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767982, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.

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