Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT01166230
First received: July 19, 2010
Last updated: November 14, 2013
Last verified: November 2013
Results First Received: August 5, 2013  
Study Type: Observational
Study Design: Time Perspective: Retrospective
Condition: Bladder Cancer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Patients With Ta/T1, Randomized to White Light Cystoscopy Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
Patients With Ta/T1 Randomized to Hexvix Cystoscopy Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.

Participant Flow:   Overall Study
    Patients With Ta/T1, Randomized to White Light Cystoscopy     Patients With Ta/T1 Randomized to Hexvix Cystoscopy  
STARTED     280     271  
COMPLETED     261     255  
NOT COMPLETED     19     16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Patients With Ta/T1, Randomized to White Light Cystoscopy Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Patients With Ta/T1 Randomized to Hexvix Cystoscopy Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Total Total of all reporting groups

Baseline Measures
    Patients With Ta/T1, Randomized to White Light Cystoscopy     Patients With Ta/T1 Randomized to Hexvix Cystoscopy     Total  
Number of Participants  
[units: participants]
  280     271     551  
Age  
[units: years]
Mean ± Standard Deviation
  69.6  ± 10.68     68  ± 10.79     68.8  ± 10.76  
Gender  
[units: participants]
     
Female     57     59     116  
Male     223     212     435  



  Outcome Measures
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1.  Primary:   Recurrence Free Survival   [ Time Frame: up to 4.5 years ]

2.  Secondary:   Rate of Progression   [ Time Frame: 4.5 years ]

3.  Other Pre-specified:   Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB   [ Time Frame: up to 5.5 years retrospectively ]

4.  Other Pre-specified:   Median Time to Recurrence   [ Time Frame: up to 4.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: H. Barton Grossman, MD
Organization: The University of Texas
phone: 713-563-7456
e-mail: hbgrossman@mdanderson.org


No publications provided


Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT01166230     History of Changes
Other Study ID Numbers: PC B305/E10
Study First Received: July 19, 2010
Results First Received: August 5, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Austria: Ethikkommission
Netherlands: Medical Ethics Review Committee (METC)
Germany: Ethics Commission