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The Bladder Instillation Comparison Study (BIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02695771
Recruitment Status : Unknown
Verified April 2017 by John E. Humphrey, Spectrum Health Hospitals.
Recruitment status was:  Recruiting
First Posted : March 1, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
John E. Humphrey, Spectrum Health Hospitals

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

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Drug: Mitomycin C Drug: Gemcitabine Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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)
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Mitomycin C
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Drug: Mitomycin C
Cancer chemotherapeutic agent
Other Name: Mutamycin

Active Comparator: Gemcitabine
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Drug: Gemcitabine
Cancer chemotherapeutic agent
Other Name: Gemzar, Novaplus

No Intervention: No intervention
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.



Primary Outcome Measures :
  1. Efficacy will be measured by the number of patients with Grade 3 through Grade 5 Adverse Events that are related to study treatment, graded according to NCI CTCAE Version 4.03 [ Time Frame: Two years ]
    To compare the efficacy of Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular vs. Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular vs. no adjuvant treatment as a single intraoperative instillation immediately after TURBT in preventing NMIBC recurrence. Efficacy will be measured by the number of patients with Grade 3 through Grade 5 AdverseEvents that are related to study treatment, graded according to NCI CTCAE Version 4.03.


Secondary Outcome Measures :
  1. Incidence of dystrophic calcification or bladder calculi [ Time Frame: Two years ]
    The secondary endpoint for this study will be the incidence of 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695771


Contacts
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Contact: Susan M Engerman, BSN 616-267-8406 susan.engerman@spectrumhealth.org
Contact: Pamela Carlon, RN 616-267-8406 pamela.carlon@spectrumhealth.org

Locations
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United States, Michigan
Spectrum Health Medical Group-Division of Urology-LHCP Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Susan M Engerman, BSN    616-267-8406    susan.engerman@spectrumhealth.org   
Contact: Pamela Carlon, RN    616-267-8406    pamela.carlon@spectrumhealth.org   
Spectrum Health Medical Group-Division of Urology Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Susan M Engerman, BSN    616-267-8406    susan.engerman@spectrumhealth.org   
Contact: Pamela Carlon, RN    616-267-8406    pamela.carlon@spectrumhealth.org   
Sub-Investigator: Richard J Kahnoski, MD         
Sub-Investigator: Brian R Lane, MD, PhD         
Sub-Investigator: Philip T Hoekstra, MD         
Sub-Investigator: Jonathan T Bolthouse, MD         
Sub-Investigator: Hector Pimentel, MD         
Sub-Investigator: Christopher M Brede, MD         
Principal Investigator: John E Humphrey, MD         
Urologic Consultants P.C. Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Susan M Engerman, BSN    616-267-8406    susan.engerman@spectrumhealth.org   
Contact: Pamela Carlon, RN    616-267-8406    pamela.carlon@spectrumhealth.org   
Sub-Investigator: John G Anema, MD         
Sub-Investigator: Jon M Curry, MD         
Sub-Investigator: Phillip G Wise, MD         
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: John E Humphrey, MD Spectrum Health Hospitals
Publications:

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Responsible Party: John E. Humphrey, Urologist, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02695771    
Other Study ID Numbers: Version 4 Date: 04.08.2016
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John E. Humphrey, Spectrum Health Hospitals:
bladder tumors
urinary tumors
non-muscle invasive bladder tumors
NMIBC
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Mitomycins
Mitomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors