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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:
ClinicalTrials.gov Identifier:
NCT00581113
First Posted: December 27, 2007
Last Update Posted: June 11, 2015
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.
Information provided by (Responsible Party):
Virginia Commonwealth University
Results First Submitted: October 6, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 Radiotherapy

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 Radiotherapy
Total Total of all reporting groups

Baseline Measures
   Neural Stem Cell-Preserving Whole Brain RT   Standard Whole Brain RT   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
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


  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
Trial not completed. Insufficient data to analyze.


  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: Martha D. Wellons
Organization: Virginia Commonwealth University
phone: 804-628-1939
e-mail: mwellons@vcu.edu



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00581113     History of Changes
Other Study ID Numbers: MCC-10655
First Submitted: December 20, 2007
First Posted: December 27, 2007
Results First Submitted: October 6, 2010
Results First Posted: February 24, 2011
Last Update Posted: June 11, 2015