Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Gemcitabine

Mitomycins

Mitomycin

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

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

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

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

Mitomycin C

Brian R Lane, MD

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.

The Bladder Instillation Comparison Study

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)

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.

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

Spectrum Health Hospitals

Urologist

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

Mitomycin C: Cancer chemotherapeutic agent

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

Gemcitabine: Cancer chemotherapeutic agent

No Intervention

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Caucasian

African American

Refused to answer

Race/Ethnicity, Customized

United States

Region of Enrollment

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.

Dr. Brian Lane

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

Freedom From Bladder Stones/Dystrophic Calcification

Overall Study

Spots Global Cancer Trial Database for The Bladder Instillation Comparison Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial