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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA014236 | U.S. NIH Grant/Contract | View source | |
| DUMC-PRO00006870 | |||
| CDR0000630230 | Other Identifier | NCI |
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Slow recruitment
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4 weeks later, patients undergo surgical resection of brain metastasis.
Quality of life and neurocognitive function are assessed periodically using the FACT-Br subscales and Mini-Mental State Exam.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Operative SRS | Experimental | SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Surgery of a single brain metastasis. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (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). | Within 12 months after SRS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery | Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery | Within 24 months post-SRS |
| Volume of Adjacent Normal Brain Parenchyma Irradiated |
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DISEASE CHARACTERISTICS:
Diagnosis of brain metastases from an extracranial primary site
Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology
RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:
No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex
No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma)
No radiographic or cytologic evidence of leptomeningeal disease
PATIENT CHARACTERISTICS:
See Disease Characteristics
Not pregnant or nursing
Negative pregnancy test
No concurrent uncontrolled illness including, but not limited to, any of the following:
No contraindication to SRS, whole-brain radiotherapy, or MRI
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| John H. Sampson, MD, PhD | Duke University | Principal Investigator |
| Hamidreza Aliabadi, MD | Duke University | Principal Investigator |
| John P. Kirkpatrick, MD | Duke University | Principal Investigator |
| James E. Herndon, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
The only reason that enrolled participants were excluded from the trial prior to treatment assignment was if there were development of any exclusion criteria.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-OP SRS | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (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). | Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS. | Posted | Number | Participants | Within 12 months after SRS |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Lally-Goss, NP | Duke University Medical Center | 919-684-3862 | denise.lallygoss@dm.duke.edu |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| stereotactic radiosurgery |
| Radiation |
Pre-operative single fraction SRS |
|
Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS). |
| At time of SRS |
| Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site | Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site. | Within 24 months post-SRS |
| Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) | 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. | Administered at baseline and every 3 months post-SRS |
| Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE) | 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. | Administered at baseline and every 3 months post-SRS |
| Clinical Significance of Locally Recurrent Brain Metastases | Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence. | 24 months post-SRS |
| Number of Patients Who Died Due to Neurological Causes | Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease. | Within 24 months post-SRS |
| Overall Survival (OS) | 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. | 24 months after SRS |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery | Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery | Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS. | Posted | Number | participants | Within 24 months post-SRS |
|
|
|
| Secondary | Volume of Adjacent Normal Brain Parenchyma Irradiated | Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS). | Data for this outcome was not collected. | Posted | At time of SRS |
|
|
| Secondary | Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site | Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site. | Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS. | Posted | Number | participants | Within 24 months post-SRS |
|
|
|
| Secondary | Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) | 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. | Data for this outcome was erroneously not gathered. | Posted | Administered at baseline and every 3 months post-SRS |
|
|
| Secondary | Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE) | 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. | Data for this outcome was erroneously not gathered. | Posted | Administered at baseline and every 3 months post-SRS |
|
|
| Secondary | Clinical Significance of Locally Recurrent Brain Metastases | Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence. | There are no patients for this analysis because none had a local recurrence. | Posted | 24 months post-SRS |
|
|
| Secondary | Number of Patients Who Died Due to Neurological Causes | Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease. | Intent-to-treat | Posted | Number | participants | Within 24 months post-SRS |
|
|
|
| Secondary | Overall Survival (OS) | 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. | Intent-to-treat | Posted | Median | 95% Confidence Interval | Months | 24 months after SRS |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |