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Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00734994
First received: May 4, 2008
Last updated: June 1, 2015
Last verified: June 2015
Results First Received: August 1, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Transitional Cell Carcinoma of Bladder
Superficial Bladder Cancer
Interventions: Device: Hyperthermia System
Drug: Mitomycin C

  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
Recruitment Period: 09/2008-09/2010 Location: Urology and Radiation Oncology Clinics

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
Mitomycin C With Hyperthermia and Recurrent Bladder Cancer Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer

Participant Flow:   Overall Study
    Mitomycin C With Hyperthermia and Recurrent Bladder Cancer
STARTED   15 
COMPLETED   14 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  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
Mitomycin C With Hyperthermia Mitomycin C and Hyperthermia

Baseline Measures
   Mitomycin C With Hyperthermia 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   8 
Gender 
[Units: Participants]
 
Female   2 
Male   13 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   15 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures
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1.  Primary:   Safety and Tolerability   [ Time Frame: During Treatment Phase average 6 weeks ]

2.  Secondary:   Median Recurrence Free-survival   [ Time Frame: Median follow-up 3.18 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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