Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01073267
First received: February 19, 2010
Last updated: November 25, 2015
Last verified: November 2015
Results First Received: November 25, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Radiation: TSEBT

  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: February 19, 2010 to April 19, 2011. All participants recruited at The University of Texas MD Anderson Cancer Center.

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
TSEBT Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.

Participant Flow:   Overall Study
    TSEBT  
STARTED     4  
COMPLETED     1  
NOT COMPLETED     3  
Disease Progression                 3  



  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
TSEBT Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.

Baseline Measures
    TSEBT  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median (Full Range)
  69  
  (48 to 69)  
Gender  
[units: participants]
 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: Baseline and at least 2 months ]


  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: Bouthaina Dabaja, MD/Associate Professor, Radiation Oncology Department
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01073267     History of Changes
Other Study ID Numbers: 2009-0444
NCI-2011-00560 ( Registry Identifier: NCI CTRP )
Study First Received: February 19, 2010
Results First Received: November 25, 2015
Last Updated: November 25, 2015
Health Authority: United States: Institutional Review Board