Trial Outcomes & Findings for The Bladder Instillation Comparison Study (NCT NCT02695771)
NCT ID: NCT02695771
Last Updated: 2023-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Two years
Results posted on
2023-04-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
26
|
27
|
|
Overall Study
COMPLETED
|
29
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Bladder Instillation Comparison Study
Baseline characteristics by cohort
| Measure |
Mitomycin C
n=29 Participants
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Mitomycin C: Cancer chemotherapeutic agent
|
Gemcitabine
n=26 Participants
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
|
No Intervention
n=27 Participants
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Continuous
|
74 years
n=5 Participants
|
69 years
n=7 Participants
|
74 years
n=5 Participants
|
73 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Refused to answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Two yearsThe 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.
Outcome measures
| Measure |
Mitomycin C
n=29 Participants
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Mitomycin C: Cancer chemotherapeutic agent
|
Gemcitabine
n=26 Participants
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
|
No Intervention
n=27 Participants
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
|
|---|---|---|---|
|
Number of Participants Without Grade ≥ 3 Adverse Event, Graded According to NCI CTCAE Version 4.03
|
15 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Two yearsThe 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
Outcome measures
| Measure |
Mitomycin C
n=29 Participants
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Mitomycin C: Cancer chemotherapeutic agent
|
Gemcitabine
n=26 Participants
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
|
No Intervention
n=27 Participants
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
|
|---|---|---|---|
|
Freedom From Bladder Stones/Dystrophic Calcification
|
24 Participants
|
23 Participants
|
25 Participants
|
Adverse Events
Mitomycin C
Serious events: 2 serious events
Other events: 9 other events
Deaths: 2 deaths
Gemcitabine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
No Intervention
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mitomycin C
n=29 participants at risk
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Mitomycin C: Cancer chemotherapeutic agent
|
Gemcitabine
n=26 participants at risk
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
|
No Intervention
n=27 participants at risk
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Femoral Fracture
|
0.00%
0/29 • 3 years
|
3.8%
1/26 • 3 years
|
0.00%
0/27 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
3.4%
1/29 • 3 years
|
0.00%
0/26 • 3 years
|
0.00%
0/27 • 3 years
|
|
Cardiac disorders
Cardiac Arrest
|
3.4%
1/29 • 3 years
|
0.00%
0/26 • 3 years
|
0.00%
0/27 • 3 years
|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
0.00%
0/29 • 3 years
|
0.00%
0/26 • 3 years
|
3.7%
1/27 • 3 years
|
Other adverse events
| Measure |
Mitomycin C
n=29 participants at risk
Mitomycin C 40 mg in 40 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Mitomycin C: Cancer chemotherapeutic agent
|
Gemcitabine
n=26 participants at risk
Gemcitabine 2 grams in 100 mL of 0.9% sodium chloride intravesicular immediately following TURBT one time.
Gemcitabine: Cancer chemotherapeutic agent
|
No Intervention
n=27 participants at risk
Patients randomized to this arm will receive no intervention intravesicular immediately following TURBT one time.
|
|---|---|---|---|
|
Renal and urinary disorders
Dystrophic calcification/bladder stone
|
17.2%
5/29 • Number of events 11 • 3 years
|
11.5%
3/26 • Number of events 8 • 3 years
|
3.7%
1/27 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
urinary retention
|
3.4%
1/29 • Number of events 1 • 3 years
|
7.7%
2/26 • Number of events 2 • 3 years
|
0.00%
0/27 • 3 years
|
|
Immune system disorders
Fever
|
6.9%
2/29 • Number of events 2 • 3 years
|
0.00%
0/26 • 3 years
|
0.00%
0/27 • 3 years
|
|
Renal and urinary disorders
hematuria
|
3.4%
1/29 • Number of events 1 • 3 years
|
0.00%
0/26 • 3 years
|
7.4%
2/27 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
urinary urgency
|
0.00%
0/29 • 3 years
|
0.00%
0/26 • 3 years
|
7.4%
2/27 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Dysuria
|
6.9%
2/29 • Number of events 2 • 3 years
|
0.00%
0/26 • 3 years
|
3.7%
1/27 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place