Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer

This study has been terminated.
(Administratively Terminated by PI)
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00358007
First received: July 27, 2006
Last updated: August 20, 2014
Last verified: August 2014
Results First Received: June 12, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Head and Neck Neoplasms
Intervention: Device: PTV Reduction

  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
Cone Beam CT Undergo a cone beam CT scan

Participant Flow:   Overall Study
    Cone Beam CT  
STARTED     30  
COMPLETED     28  
NOT COMPLETED     2  



  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
Cone Beam CT Undergo a cone beam CT scan

Baseline Measures
    Cone Beam CT  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  58.19  ± 12.21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     9  
Gender  
[units: participants]
 
Female     9  
Male     21  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     25  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     28  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Average Interfraction Shift of Patients Undergoing Radiotherapy   [ Time Frame: Daily prior to radiation ]

2.  Primary:   Average Residual Error Motion of Patients Undergoing Radiotherapy   [ Time Frame: Daily after each radiotherapy treatment ]


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


Results Point of Contact:  
Name/Title: Pramila Rani Anne, MD
Organization: Thomas Jefferson University
phone: 215-955-6702
e-mail: Pramila.Anne@jefferson.edu


Publications of Results:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00358007     History of Changes
Other Study ID Numbers: 06U.195, 2006-10
Study First Received: July 27, 2006
Results First Received: June 12, 2014
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board