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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734994
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : August 30, 2011
Last Update Posted : June 29, 2015
Information provided by (Responsible Party):
Mark Dewhirst, Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Transitional Cell Carcinoma of Bladder
Superficial Bladder Cancer
Interventions: Device: Hyperthermia System
Drug: Mitomycin C

  Participant Flow

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
No text entered.

Reporting Groups
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
Withdrawal by Subject                1 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
Mitomycin C With Hyperthermia Mitomycin C and Hyperthermia

Baseline Measures
   Mitomycin C With Hyperthermia 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   8 
[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

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

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Brant A. Inman, MD, MS
Organization: Duke University, Division of Urology
phone: 919 684-1322

Publications of Results:
Other Publications:

Responsible Party: Mark Dewhirst, Duke University Identifier: NCT00734994     History of Changes
Other Study ID Numbers: Pro00003239
First Submitted: May 4, 2008
First Posted: August 14, 2008
Results First Submitted: August 1, 2011
Results First Posted: August 30, 2011
Last Update Posted: June 29, 2015