Urinary Bladder Neoplasms
Conditions
Keywords
bladder tumors, urinary tumors, non-muscle invasive bladder tumors, NMIBC
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.
Interventions
DRUGMitomycin C
Cancer chemotherapeutic agent
DRUGGemcitabine
Cancer chemotherapeutic agent
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Bladder Stones/Dystrophic Calcification | Two years | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| Gemcitabine Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent | 26 |
| No Intervention Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time. | 27 |
| Total | 82 |
Baseline characteristics
| Characteristic | Mitomycin C | Gemcitabine | No Intervention | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 18 Participants | 19 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 8 Participants | 22 Participants |
| Age, Continuous | 74 years | 69 years | 74 years | 73 years |
| Race/Ethnicity, Customized African American | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 28 Participants | 24 Participants | 25 Participants | 77 Participants |
| Race/Ethnicity, Customized Refused to answer | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 29 Participants | 26 Participants | 27 Participants | 82 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 21 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 29 | 1 / 26 | 1 / 27 |
| other Total, other adverse events | 9 / 29 | 5 / 26 | 5 / 27 |
| serious Total, serious adverse events | 2 / 29 | 1 / 26 | 1 / 27 |
Outcome results
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.
Time frame: Two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mitomycin C | Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 | 15 Participants |
| Gemcitabine | Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 | 14 Participants |
| No Intervention | Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03 | 20 Participants |
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
Time frame: Two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mitomycin C | Freedom From Bladder Stones/Dystrophic Calcification | 24 Participants |
| Gemcitabine | Freedom From Bladder Stones/Dystrophic Calcification | 23 Participants |
| No Intervention | Freedom From Bladder Stones/Dystrophic Calcification | 25 Participants |