Urinary Bladder NeoplasmsPhase 3BICNCT02695771

The Bladder Instillation Comparison Study

A Phase 3 study testing Mitomycin C and Gemcitabine in people with Urinary Bladder Neoplasms, run by Corewell Health West at 3 sites in United States.

Completed

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

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Bladder Neoplasms
What is being tested?: Mitomycin C and Gemcitabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 3 sitesUnited States
Study dates: 19 Apr 2016to 22 Oct 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Spectrum Health Medical Group-Division of Urology-LHCP
Grand Rapids, Michigan, 49503
Spectrum Health Medical Group-Division of Urology
Grand Rapids, Michigan, 49503
Urologic Consultants P.C.
Grand Rapids, Michigan, 49503

Other trials in United States

About this study

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)

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

Read the 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.

Conditions: Urinary Bladder Neoplasms
Being tested: Mitomycin C, Gemcitabine
Keywords: bladder tumors, urinary tumors, non-muscle invasive bladder tumors, NMIBC
Medical subject headings: Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

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

Mitomycin CDrug
Also called Mutamycin
Cancer chemotherapeutic agent
GemcitabineDrug
Also called Gemzar, Novaplus
Cancer chemotherapeutic agent

Study groups in NCT02695771
Study group	Role	What they receive
Mitomycin C	Experimental	Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. Receives: Drug: Mitomycin C
Gemcitabine	Active comparator	Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. Receives: Drug: Gemcitabine
No intervention	No intervention	Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.

What is being measured

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

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.
Measured: Two years

Secondary outcomes (1)

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
Measured: Two years

Timeline

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

19 Apr 201622 Oct 2021

First posted1 Mar 2016 (estimated)
Study start19 Apr 2016
Primary completion22 Oct 2021
Study completion22 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02695771
Sponsor's protocol ID: 2016-030
Acronym: BIC
Status last verified: Apr 2023
First submitted: 9 Feb 2016
Last updated: 21 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25836930
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.
PubMed 25234184
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.
PubMed 26188393
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.
PubMed 15126782
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.
PubMed 11309436
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.
PubMed 23584349
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.
PubMed 34125951

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Bladder Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02695771
Acronym / sponsor ID: BIC / 2016-030
Conditions: Urinary Bladder Neoplasms
Keywords: bladder tumors, urinary tumors, non-muscle invasive bladder tumors, NMIBC
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Corewell Health WestUniversity, hospital or other
Study start: 19 Apr 2016 (actual)
Primary completion: 22 Oct 2021 (actual)
Study completion: 22 Oct 2021 (actual)
First posted: 1 Mar 2016 (estimated)
Results: Posted 21 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Mitomycin C	Experimental	Drug: Mitomycin CMitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine	Active comparator	Drug: GemcitabineGemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
No intervention	No intervention	–Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mitomycin CAlso: MutamycinCancer chemotherapeutic agent	Drug	Mitomycin C
GemcitabineAlso: Gemzar, NovaplusCancer chemotherapeutic agent	Drug	Gemcitabine

Primary outcome

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.

1 secondary outcome

Freedom From Bladder Stones/Dystrophic Calcification
Time frame: Two years

Results and safety

Results posted to the registry on 21 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mitomycin C	29	29
Gemcitabine	26	26
No Intervention	27	27

Primary outcome: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03

Time frame: Two years. Count of participants. Unit: Participants

Measure	Mitomycin C n = 29	Gemcitabine n = 26	No Intervention n = 27
Value	15	14	20

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mitomycin C	2 of 29 (6.9%)	9 of 29 (31%)	2 of 29
Gemcitabine	1 of 26 (3.8%)	5 of 26 (19.2%)	1 of 26
No Intervention	1 of 27 (3.7%)	5 of 27 (18.5%)	1 of 27

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25836930Weijers 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.
Background: PubMed 25234184Pagano 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.
Background: PubMed 26188393Roupret 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.
Background: PubMed 15126782Sylvester 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.
Background: PubMed 11309436Au 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.
Background: PubMed 23584349Montgomery 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.
Derived from this study: PubMed 34125951Han 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian R Lane, MD principal investigator

Corewell Health West

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mitomycin C and Gemcitabine in people with Urinary Bladder Neoplasms, run by Corewell Health West at 3 sites in United States.

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 2 inclusion and 6 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 (time frame: Two years). 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 NCT02695771, which also lists 7 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 21 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.