Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

This study has been terminated.
(New research priorities)
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00581113
First received: December 20, 2007
Last updated: January 27, 2011
Last verified: January 2011
Results First Received: October 6, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Cancer
Breast Cancer
Prostate Cancer
Intervention: Radiation: Radiotherapy

  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
Patients were recruited from 08/2007 through 07/2008 in Radiation Oncology clinic

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
Neural Stem Cell-Preserving Whole Brain RT Neural Stem Cell-Preserving Whole Brain Radiotherapy
Standard Whole Brain RT Standard Whole Brain RT

Participant Flow:   Overall Study
    Neural Stem Cell-Preserving Whole Brain RT     Standard Whole Brain RT  
STARTED     4     4  
COMPLETED     4     3  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 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.
No text entered.

Reporting Groups
  Description
Neural Stem Cell-Preserving Whole Brain RT Neural Stem Cell-Preserving Whole Brain Radiotherapy
Standard Whole Brain RT Standard Whole Brain RT
Total Total of all reporting groups

Baseline Measures
    Neural Stem Cell-Preserving Whole Brain RT     Standard Whole Brain RT     Total  
Number of Participants  
[units: participants]
  4     4     8  
Age  
[units: participants]
     
Between 18 and 65 years     1     4     5  
>=65 years     3     0     3  
Age  
[units: years]
Mean ± Standard Deviation
  67.2  ± 9.7     52.0  ± 0.0     59.6  ± 0.6  
Gender  
[units: participants]
     
Female     1     2     3  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     4     4     8  



  Outcome Measures
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1.  Primary:   Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.   [ Time Frame: 12 months post RT ]

2.  Secondary:   Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.   [ Time Frame: 12 months after end of radiation therapy ]


  Serious Adverse Events


  Other Adverse Events


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


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
Trial not completed. Insufficient data to analyze.  


Results Point of Contact:  
Name/Title: Martha D. Wellons
Organization: Virginia Commonwealth University
phone: 804-628-1939
e-mail: mwellons@vcu.edu


No publications provided


Responsible Party: Mitchell S. Anscher, MD, Massey Cancer Center/Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00581113     History of Changes
Other Study ID Numbers: MCC-10655
Study First Received: December 20, 2007
Results First Received: October 6, 2010
Last Updated: January 27, 2011
Health Authority: United States: Institutional Review Board