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The Bladder Instillation Comparison Study (BIC)

Primary Purpose

Urinary Bladder Neoplasms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mitomycin C
Gemcitabine
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Bladder Neoplasms focused on measuring bladder tumors, urinary tumors, non-muscle invasive bladder tumors, NMIBC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Spectrum Health Medical Group-Division of Urology-LHCP
  • Spectrum Health Medical Group-Division of Urology
  • Urologic Consultants P.C.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mitomycin C

Gemcitabine

No intervention

Arm Description

Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.

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

Outcomes

Primary Outcome Measures

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

Freedom From Bladder Stones/Dystrophic Calcification
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

Full Information

First Posted
February 9, 2016
Last Updated
April 11, 2023
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02695771
Brief Title
The Bladder Instillation Comparison Study
Acronym
BIC
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2016 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms
Keywords
bladder tumors, urinary tumors, non-muscle invasive bladder tumors, NMIBC

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mitomycin C
Arm Type
Experimental
Arm Description
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Other Intervention Name(s)
Mutamycin
Intervention Description
Cancer chemotherapeutic agent
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar, Novaplus
Intervention Description
Cancer chemotherapeutic agent
Primary Outcome Measure Information:
Title
Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
Description
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.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Freedom From Bladder Stones/Dystrophic Calcification
Description
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
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian R Lane, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health Medical Group-Division of Urology-LHCP
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Medical Group-Division of Urology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Urologic Consultants P.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25836930
Citation
Weijers Y, Arentsen HC, Arends TJ, Witjes JA. Management of low-risk and intermediate-risk non-muscle-invasive bladder carcinoma. Hematol Oncol Clin North Am. 2015 Apr;29(2):219-25, vii. doi: 10.1016/j.hoc.2014.11.001.
Results Reference
background
PubMed Identifier
25234184
Citation
Pagano MJ, Badalato G, McKiernan JM. Optimal treatment of non-muscle invasive urothelial carcinoma including perioperative management revisited. Curr Urol Rep. 2014 Nov;15(11):450. doi: 10.1007/s11934-014-0450-1.
Results Reference
background
PubMed Identifier
26188393
Citation
Roupret M, Babjuk M, Comperat E, Zigeuner R, Sylvester RJ, Burger M, Cowan NC, Bohle A, Van Rhijn BW, Kaasinen E, Palou J, Shariat SF. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Cell Carcinoma: 2015 Update. Eur Urol. 2015 Nov;68(5):868-79. doi: 10.1016/j.eururo.2015.06.044. Epub 2015 Jul 16.
Results Reference
background
PubMed Identifier
15126782
Citation
Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a meta-analysis of published results of randomized clinical trials. J Urol. 2004 Jun;171(6 Pt 1):2186-90, quiz 2435. doi: 10.1097/01.ju.0000125486.92260.b2.
Results Reference
background
PubMed Identifier
11309436
Citation
Au JL, Badalament RA, Wientjes MG, Young DC, Warner JA, Venema PL, Pollifrone DL, Harbrecht JD, Chin JL, Lerner SP, Miles BJ; International Mitomycin C Consortium. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst. 2001 Apr 18;93(8):597-604. doi: 10.1093/jnci/93.8.597.
Results Reference
background
PubMed Identifier
23584349
Citation
Montgomery JS, Miller DC, Weizer AZ. Quality indicators in the management of bladder cancer. J Natl Compr Canc Netw. 2013 Apr 1;11(4):492-500. doi: 10.6004/jnccn.2013.0061.
Results Reference
background
PubMed Identifier
34125951
Citation
Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.
Results Reference
derived

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The Bladder Instillation Comparison Study

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