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Completed

NCT Number: NCT02695771

The Bladder Instillation Comparison Study

To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

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Key information

Conditions

Urinary Bladder Neoplasms 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 Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Spectrum Health Medical Group-Division of Urology, Grand Rapids, Michigan, United States

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About this study

This study will compare standard of care treatment for patients with non-muscle invasive bladder cancer (NMIBC). Patients will be randomized to one of three arms, Mitomycin C, Gemcitabine or no additional treatment immediately following TURBT in the operating suite. All treatment, surgical procedures and follow up care will be conducted according to standard of care treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • sign an informed consent for the study
  • be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion criteria

  • patients unable to consent for themselves
  • individuals under 18 years old
  • pregnant women
  • prisoners
  • patients with known allergy or intolerance to the mitomycin C or Gemcitabine
  • any other sound medical, psychiatric and/or social reason as determined by the investigator.

Treatment and study plan

mitomycin C

Drug

Cancer chemotherapeutic agent

Other names: Mutamycin

Gemcitabine

Drug

Cancer chemotherapeutic agent

Other names: Gemzar, Novaplus

Primary outcomes

  1. Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03

    Time frame: Two years

    The NCI CTCAE Version 4.03 grades adverse events as follows: grade 3 include severe but non-life-threatening consequences that result in hospitalization and/or interventions, including elective radiologic or operative interventions; grade 4 events include life-threatening consequences, such as those requiring urgent reoperation; and grade 5 events result in treatment-related death.

Secondary outcomes

  1. Freedom From Bladder Stones/Dystrophic Calcification

    Time frame: Two years

    The secondary endpoint for this study will be the number of subjects who did not experience dystrophic calcification or bladder calculi measured by the number of patients with Grade 3 through Grade 5 Adverse Events that are related to study arm, graded according to NCI CTCAE Version 4.03.Version 4.03

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT)

Acronym: BIC

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2016
Registry last updated
Apr 21, 2023

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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