Trial Outcomes & Findings for Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients (NCT NCT00974818)
NCT ID: NCT00974818
Last Updated: 2015-11-20
Results Overview
will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
2 years
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Mitomycin C (MMC)
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
|
Bacillus Calmette-Guerin (BCG)
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
Baseline characteristics by cohort
| Measure |
Mitomycin C (MMC)
n=25 Participants
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
|
Bacillus Calmette-Guerin (BCG)
n=25 Participants
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Due to a lack of patients accrued to the protocol the protocol was closed and the analysis of the 2 year relapse rates could not be compared.
will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.
Outcome measures
| Measure |
Mitomycin C (MMC)
n=25 Participants
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
|
Bacillus Calmette-Guerin (BCG)
n=25 Participants
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
|
|---|---|---|
|
Response to Treatment
|
25 participants
|
25 participants
|
Adverse Events
Mitomycin C (MMC)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Bacillus Calmette-Guerin (BCG)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mitomycin C (MMC)
n=25 participants at risk
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
|
Bacillus Calmette-Guerin (BCG)
n=25 participants at risk
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
|
|---|---|---|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
Mitomycin C (MMC)
n=25 participants at risk
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
|
Bacillus Calmette-Guerin (BCG)
n=25 participants at risk
Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
|
|---|---|---|
|
Renal and urinary disorders
Cystitis
|
16.0%
4/25 • Number of events 6
|
40.0%
10/25 • Number of events 12
|
|
General disorders
Pain - Penis
|
8.0%
2/25 • Number of events 2
|
0.00%
0/25
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
8.0%
2/25 • Number of events 2
|
0.00%
0/25
|
Additional Information
Dr. Guido Dalbagni
Memorial Slaon Kettering Cancer Center
Phone: 646-422-4394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place