Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2016-04-19
2021-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Mitomycin C
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Mitomycin C
Cancer chemotherapeutic agent
Gemcitabine
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine
Cancer chemotherapeutic agent
No intervention
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
No interventions assigned to this group
Interventions
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Mitomycin C
Cancer chemotherapeutic agent
Gemcitabine
Cancer chemotherapeutic agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Spectrum Health Hospitals
OTHER
Responsible Party
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Brian R. Lane
Urologist
Principal Investigators
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Brian R Lane, MD
Role: PRINCIPAL_INVESTIGATOR
Spectrum Health Hospitals
Locations
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Spectrum Health Medical Group-Division of Urology-LHCP
Grand Rapids, Michigan, United States
Spectrum Health Medical Group-Division of Urology
Grand Rapids, Michigan, United States
Urologic Consultants P.C.
Grand Rapids, Michigan, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-030
Identifier Type: -
Identifier Source: org_study_id
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