Clinical Trial Results:
TREATMENT OF Ta BLADDER CANCER WITH HIGH RISK OF RECURRENCE – FLUORESCENCE CYSTOSCOPY WITH OPTIMIZED ADJUVANT MITOMYCIN-C
Summary
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EudraCT number |
2012-000559-15 |
Trial protocol |
FI |
Global end of trial date |
01 Nov 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Dec 2024
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First version publication date |
21 Dec 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FB2012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01675219 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
FinnBladder
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Sponsor organisation address |
Sairaalakatu 1, Vantaa, Finland, 05850
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Public contact |
FinnBladder office, FinnBladder, +358 9471 66681, aini.salo@hus.fi
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Scientific contact |
FinnBladder office, FinnBladder, +358 9471 66681, aini.salo@hus.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Nov 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
1) To evaluate whether the adjuvant 6-weekly optimized MMC instillation therapy is better than single immediate postoperative instillation therapy in reducing recurrences.
2) To evaluate whether the PDD-guided TUR-BT is better than the conventional white light TUR-BT in reducing recurrence, which implies evaluation of whether the effect of PDD-guided TUR-BT is additive to MMC instillation therapy
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Protection of trial subjects |
Every patient will be informed about the modalities in accordance with the enclosed patient information sheet. The patient is informed both in writing and verbally by the physician. The patient must have the opportunity to decide whether or not to participate in the clinical trial. The explanatory information includes the following points:
-nature of the disease
-general prognosis
-presently available diagnostic procedures
-type and aims of the clinical study
-information on the substance to be tested
-effects and side effects of therapy to be expected
-laboratory and clinical tests
to be performed
-regulations regarding confidentiality and divulgence of information
-possible review of patient data by the authorities
-storage of data
-duties of the patient (no specific duties)
Both the informing physician and the patient must sign a declaration of consent.
The patient will retain a copy of the declaration.
The declarations of consent are part of the patient file and will be retained with this.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 510
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Worldwide total number of subjects |
510
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EEA total number of subjects |
510
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
108
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From 65 to 84 years |
380
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85 years and over |
22
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Recruitment
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Recruitment details |
Recruitment of patients was performed in Finland. Recruitment was done during the period of 13.12.2022-29.4.2022. | |||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects were identified in academic urological centers and reviewed or eligibility | |||||||||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | |||||||||||||||||||||||||
Arm description |
Patients with TUR-‐BT performed under white light, followed by a single instillation of epirubicin. | |||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Group B | |||||||||||||||||||||||||
Arm description |
Patients with TUR-‐BT performed using PDD, followed by a single instillation of epirubicin. | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Hexvix
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Bladder irrigation
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Routes of administration |
Intravesical use
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Dosage and administration details |
85 mg milligrams intravesically
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Arm title
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Group C | |||||||||||||||||||||||||
Arm description |
Patients with TUR-‐BT performed under white light, followed by a single instillation of epirubicin plus six optimized MMC instillations | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Mitostat
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Investigational medicinal product code |
PR2
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Other name |
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Pharmaceutical forms |
Bladder irrigation
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Routes of administration |
Intravesical use
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Dosage and administration details |
40 mg milligrams intravesically
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Arm title
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Group D | |||||||||||||||||||||||||
Arm description |
Patients with TUR-‐BT performed using PDD, followed by a single instillation of epirubicin plus six optimized MMC instillations | |||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||
Investigational medicinal product name |
Hexvix
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Bladder irrigation
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Routes of administration |
Intravesical use
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Dosage and administration details |
85 mg milligrams intravesically
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Investigational medicinal product name |
Mitostat
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Investigational medicinal product code |
PR2
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Other name |
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Pharmaceutical forms |
Bladder irrigation
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Routes of administration |
Intravesical use
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Dosage and administration details |
40 mg milligrams intravesically
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End points reporting groups
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Reporting group title |
Group A
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Reporting group description |
Patients with TUR-‐BT performed under white light, followed by a single instillation of epirubicin. | ||
Reporting group title |
Group B
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Reporting group description |
Patients with TUR-‐BT performed using PDD, followed by a single instillation of epirubicin. | ||
Reporting group title |
Group C
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Reporting group description |
Patients with TUR-‐BT performed under white light, followed by a single instillation of epirubicin plus six optimized MMC instillations | ||
Reporting group title |
Group D
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Reporting group description |
Patients with TUR-‐BT performed using PDD, followed by a single instillation of epirubicin plus six optimized MMC instillations |
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End point title |
Bladder cancer recurrence [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Analysis of time to From randomisation to recurrence or to last follow-up date.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Preparing final publication and data available after publication |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall trial 13.12.2012-1.11.2024
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Adverse event reporting additional description |
As this was academic, investigator initiated trial investigating authorised products in routine clinical use, no formal monitoring was carried out
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
2.1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Preparing final publication and data available after publication |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/31177305 http://www.ncbi.nlm.nih.gov/pubmed/35094962 |