NCT02695771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 21, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

5.5 years

First QC Date

February 9, 2016

Results QC Date

February 7, 2023

Last Update Submit

April 11, 2023

Conditions

Urinary Bladder Neoplasms

Keywords

bladder tumorsurinary tumorsnon-muscle invasive bladder tumorsNMIBC

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two years

Secondary Outcomes (1)

  • Freedom From Bladder Stones/Dystrophic Calcification

    Two years

Study Arms (3)

Mitomycin C

EXPERIMENTAL

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

Drug: Mitomycin C

Gemcitabine

ACTIVE COMPARATOR

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

Drug: Gemcitabine

No intervention

NO INTERVENTION

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

Interventions

Mitomycin CDRUG

Cancer chemotherapeutic agent

Also known as: Mutamycin
Mitomycin C
GemcitabineDRUG

Cancer chemotherapeutic agent

Also known as: Gemzar, Novaplus
Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Spectrum Health Medical Group-Division of Urology-LHCP

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Medical Group-Division of Urology

Grand Rapids, Michigan, 49503, United States

Location

Urologic Consultants P.C.

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (7)

  • 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.

    PMID: 25836930BACKGROUND

  • 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.

    PMID: 25234184BACKGROUND

  • 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.

    PMID: 26188393BACKGROUND

  • 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.

    PMID: 15126782BACKGROUND

  • 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.

    PMID: 11309436BACKGROUND

  • 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.

    PMID: 23584349BACKGROUND

  • 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.

    PMID: 34125951DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder Neoplasms

Interventions

MitomycinGemcitabine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

Limitations and Caveats

The limitations of this study are evident given the early closure and being underpowered. Enrollment was suspended due to protocol deviations concerning randomization and physician bias. A review of the protocol deviations revealed the primary errors made were noted during the consent process. Specifically, patients were consented by individuals not identified as part of the research team and others consented the day of the procedure, both in violation of the protocol.

Results Point of Contact

Title
Dr. Brian Lane
Organization
Corewell Health
brian.lane@corewellhealth.org
616-267-7333

Study Officials

  • Brian R Lane, MD

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urologist

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 1, 2016

Study Start

April 19, 2016

Primary Completion

October 22, 2021

Study Completion

October 22, 2021

Last Updated

April 21, 2023

Results First Posted

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)