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To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin C | Experimental | Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. |
|
| Gemcitabine | Active Comparator | Gemcitabine 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin C | Drug | Cancer chemotherapeutic agent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian R Lane, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health Medical Group-Division of Urology-LHCP | Grand Rapids | Michigan | 49503 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25836930 | Background | 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. | |
| 25234184 | Background | 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. |
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recruitment goals were not met as study was stopped early by the IRB. Enrollment was suspended due to protocol deviations concerning randomization and physician bias.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Gemcitabine | Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. Gemcitabine: Cancer chemotherapeutic agent |
| FG002 | No Intervention | Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Gemcitabine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Two years |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Right subcapital femoral neck fracture and patient was admitted to orthopedic surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dystrophic calcification/bladder stone | Renal and urinary disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Lane | Corewell Health | 616-267-7333 | brian.lane@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2019 | Feb 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| Gemcitabine | Drug | Cancer chemotherapeutic agent |
|
|
| Spectrum Health Medical Group-Division of Urology |
| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| Urologic Consultants P.C. | Grand Rapids | Michigan | 49503 | United States |
| 26188393 | Background | 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. |
| 15126782 | Background | 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. |
| 11309436 | Background | 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. |
| 23584349 | Background | 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. |
| 34125951 | Derived | 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. |
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
| BG002 | No Intervention | Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
| OG002 | No Intervention | Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time. |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Two years |
|
|
|
| 2 |
| 29 |
| 2 |
| 29 |
| 9 |
| 29 |
| EG001 | Gemcitabine | Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time. Gemcitabine: Cancer chemotherapeutic agent | 1 | 26 | 1 | 26 | 5 | 26 |
| EG002 | No Intervention | Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time. | 1 | 27 | 1 | 27 | 5 | 27 |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment | Persistent hematuria with clot retention requiring foley catheter and continuous bladder irrigation. Patient underwent cystoscopy with clot evacuation and fulguration |
|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment | cardiac arrest secondary to ventricular fibrillation with inferior STEMI |
|
| Thromboembolic Event | Blood and lymphatic system disorders | Non-systematic Assessment | Left lower extremity claudication with history of left superficial femoral artery stent with thrombosis of stent |
|
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Fever | Immune system disorders | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |