Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: Endpoint Classification: Safety/Efficacy Study;   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
  Hide 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
  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
  Hide 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
  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
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: brant.inman@duke.edu


Publications of Results:
Other Publications:

Responsible Party: Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00734994     History of Changes
Other Study ID Numbers: Pro00003239
Study First Received: May 4, 2008
Results First Received: August 1, 2011
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration