Trial Outcomes & Findings for Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases (NCT NCT00581113)

Results Overview

Brain metastases bi-dimensional area

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

12 months post RT

Results posted on

2015-06-11

Participant Flow

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

Participant milestones

Participant milestones
Measure	Neural Stem Cell-Preserving Whole Brain RT Neural Stem Cell-Preserving Whole Brain Radiotherapy	Standard Whole Brain RT Standard Whole Brain Radiotherapy
Overall Study STARTED	4	4
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Neural Stem Cell-Preserving Whole Brain RT Neural Stem Cell-Preserving Whole Brain Radiotherapy	Standard Whole Brain RT Standard Whole Brain Radiotherapy
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neural Stem Cell-Preserving Whole Brain RT n=4 Participants Neural Stem Cell-Preserving Whole Brain Radiotherapy	Standard Whole Brain RT n=4 Participants Standard Whole Brain Radiotherapy	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	67.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	52.0 years STANDARD_DEVIATION 0.0 • n=7 Participants	59.6 years STANDARD_DEVIATION 0.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post RT

Population: Not enough patients were enrolled to allow for any meaningful analysis.

Brain metastases bi-dimensional area

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after end of radiation therapy

Population: Study terminated early due to poor accrual

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.

Outcome measures

Outcome data not reported

Adverse Events

Neural Stem Cell-Preserving Whole Brain RT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Whole Brain RT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neural Stem Cell-Preserving Whole Brain RT n=4 participants at risk Neural Stem Cell-Preserving Whole Brain Radiotherapy	Standard Whole Brain RT n=4 participants at risk Standard Whole Brain RT
Nervous system disorders Cognitive disturbance - New Brain Mets	0.00% 0/4	25.0% 1/4 • Number of events 1
Nervous system disorders Neurology - Other (Disease Progression)	25.0% 1/4 • Number of events 1	0.00% 0/4

Other adverse events

Adverse event data not reported

Additional Information

Martha D. Wellons

Virginia Commonwealth University

Phone: 804-628-1939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place