Clinical trial NCT02695771: The Bladder Instillation Comparison 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
Keywords: bladder tumors
urinary tumors
non-muscle invasive bladder tumors
NMIBC
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
timeFrame: Two years
Secondary outcomes:
measure: Freedom From Bladder Stones/Dystrophic Calcification
timeFrame: Two years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group-Division of Urology-LHCP
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group-Division of Urology
state: Michigan
city: Grand Rapids
country: United States
facility: Urologic Consultants P.C.
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Brian R Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.