Trial Outcomes & Findings for Stereotactic Radiosurgery in Treating Patients With Brain Metastases (NCT NCT00811655)
NCT ID: NCT00811655
Last Updated: 2013-11-25
Results Overview
Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).
TERMINATED
PHASE2
6 participants
Within 12 months after SRS
2013-11-25
Participant Flow
The subjects were consented and interviewed in a private room in the Duke clinics. The patients came to Duke Radiology Center, found to be eligible and then provided options by the neuro-radiologist. They were consented by the research nurse at one of these visits.
The only reason that enrolled participants were excluded from the trial prior to treatment assignment was if there were development of any exclusion criteria.
Participant milestones
| Measure |
Pre-Operative SRS
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS
|
|---|---|
|
Overall Study
STARTED
|
6
|
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Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pre-Operative SRS
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Stereotactic Radiosurgery in Treating Patients With Brain Metastases
Baseline characteristics by cohort
| Measure |
Pre-OP SRS
n=6 Participants
SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS
|
|---|---|
|
Age Continuous
|
55.7 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 12 months after SRSPopulation: Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.
Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).
Outcome measures
| Measure |
Pre-Operative SRS
n=5 Participants
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
|
|---|---|
|
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 24 months post-SRSPopulation: Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.
Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery
Outcome measures
| Measure |
Pre-Operative SRS
n=5 Participants
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
|
|---|---|
|
Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
|
2 participants
|
SECONDARY outcome
Timeframe: At time of SRSPopulation: Data for this outcome was not collected.
Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 24 months post-SRSPopulation: Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.
Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.
Outcome measures
| Measure |
Pre-Operative SRS
n=5 Participants
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
|
|---|---|
|
Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site
|
2 participants
|
SECONDARY outcome
Timeframe: Administered at baseline and every 3 months post-SRSPopulation: Data for this outcome was erroneously not gathered.
Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Administered at baseline and every 3 months post-SRSPopulation: Data for this outcome was erroneously not gathered.
Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-SRSPopulation: There are no patients for this analysis because none had a local recurrence.
Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 24 months post-SRSPopulation: Intent-to-treat
Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.
Outcome measures
| Measure |
Pre-Operative SRS
n=6 Participants
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
|
|---|---|
|
Number of Patients Who Died Due to Neurological Causes
|
0 participants
|
SECONDARY outcome
Timeframe: 24 months after SRSPopulation: Intent-to-treat
Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Pre-Operative SRS
n=6 Participants
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
|
|---|---|
|
Overall Survival (OS)
|
6.6 Months
Interval 3.5 to 13.2
|
Adverse Events
Pre-Operative SRS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-Operative SRS
n=6 participants at risk
Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
therapeutic conventional surgery : Surgery of a single brain metastasis.
stereotactic radiosurgery : Pre-operative single fraction SRS
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Fatigue
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
General disorders
Pain
|
33.3%
2/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Injury, poisoning and procedural complications
Fracture
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Ataxia
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Dysphasia
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
2/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
2/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
1/6 • 24 months
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place