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:
Virginia Commonwealth University
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00581113
First received: December 20, 2007
Last updated: January 27, 2011
Last verified: January 2011
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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
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
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
| 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 ] |
| Measure Type | Primary |
|---|---|
| Measure Title | 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. |
| Measure Description | Brain metastases bi-dimensional area |
| Time Frame | 12 months post RT |
| Safety Issue | No |
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. |
|---|
| Not enough patients were enrolled to allow for any meaningful analysis. |
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 |
Measured Values
| Neural Stem Cell-Preserving Whole Brain RT | Standard Whole Brain RT | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
0 | 0 |
|
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.
[units: mm] Mean ± Standard Deviation |
No statistical analysis provided for 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.
| 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 ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | 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. |
| Measure Description | 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 |
| Safety Issue | No |
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. |
|---|
| Study terminated early due to poor accrual |
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 |
Measured Values
| Neural Stem Cell-Preserving Whole Brain RT | Standard Whole Brain RT | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
0 | 0 |
|
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.
[units: metastatic lesions] Mean ± Standard Deviation |
No statistical analysis provided for 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.
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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
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 |