Urothelial Carcinoma
Conditions
Brief summary
Results of previous studies suggest that the timing of intravesical mitomycin C administration may impact bladder tumor recurrence rate following radical nephroureterectomy. This is the first study of its kind to attempt to identify the importance of timing of mitomycin C administration relative to bladder tumor recurrence rate following radical nephroureterectomy.This study will investigate the one year bladder tumor recurrence rate in patients with urothelial carcinoma of the upper urinary tract following intraoperative administration of mitomycin C during a nephroureterectomy, as well as the time to bladder tumor recurrence in this patient population.
Interventions
DRUGMitomycin c
All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Both males and females ≥ eighteen years of age * Clinical diagnosis of urothelial carcinoma of the renal pelvis and/or ureter. Clinical diagnosis of urothelial carcinoma may be based upon radiographic, pathologic or cytological findings alone or in combination with one another. No other histology is allowed. * The TNM stage of the subject's disease (using the American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition) must be Tis, Ta, T1, T2, or T3, N0, M0. Subjects may have either a high-grade or low-grade tumor. * ECOG performance status of 0-2 * Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy prior to and for at least 3 months after mitomycin C instillation to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. * Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) should avoid conceiving children prior to and for 3 months following mitomycin C instillation * Subjects must have hemoglobin ≥ 9 g/dL and a platelet count ≥ 100,000/μL.
Exclusion criteria
* Active urothelial carcinoma of the bladder within 12 months prior to enrollment * History of adverse reaction to mitomycin C * Evidence of regional or metastatic disease. * History of radical cystectomy * Planned radical cystectomy at the time of nephroureterectomy * Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy prior to and for at least 3 months after mitomycin C instillation. * Females who are pregnant or breastfeeding. * History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated. * Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. * Subjects demonstrating an inability to comply with the study and/or follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder Tumor Recurrence Rate | 1 year | The bladder tumor recurrence rate will be measured by the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Bladder Tumor Recurrence | 3 years | Determine the median time to bladder tumor recurrence. A subject is considered to have had a bladder tumor recurrence when they have been confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy. |
| Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively | 3 years | Determine the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy 3 years post-operatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mitomycin C Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Mitomycin C |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 70.14 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 29 |
| other Total, other adverse events | 27 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
Primary
Bladder Tumor Recurrence Rate
The bladder tumor recurrence rate will be measured by the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy
Time frame: 1 year
Population: all 29 subjects enrolled have reached the 1 year post-surgery timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitomycin C | Bladder Tumor Recurrence Rate | 41.37 percentage of subjects |
Secondary
Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively
Determine the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy 3 years post-operatively.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitomycin C | Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively | 58.62 percentage of subjects |
Secondary
Time to Bladder Tumor Recurrence
Determine the median time to bladder tumor recurrence. A subject is considered to have had a bladder tumor recurrence when they have been confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy.
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mitomycin C | Time to Bladder Tumor Recurrence | 464 days |