Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
NCT ID: NCT00814463
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2008-08-31
2009-06-30
Brief Summary
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PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
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Detailed Description
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Primary
* To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).
Secondary
* To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone.
* To estimate the rate of new brain metastases outside of the adjuvant SRS site.
* To estimate patient quality of life after adjuvant SRS alone.
* To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients.
* To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients.
* To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease.
* To estimate the overall survival of these patients.
OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.
Quality of life and neurocognitive function are assessed periodically.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
MMSE
Neurocognitive function via MMSE done every 3 months for length of study.
QOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.
MRI
MRI done every 3 months for the length of the study.
Post-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Interventions
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MMSE
Neurocognitive function via MMSE done every 3 months for length of study.
QOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.
MRI
MRI done every 3 months for the length of the study.
Post-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
4. Life expectancy of at least 3 months.
Exclusion Criteria
2. Patient with incomplete or partial resection.
3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
4. Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan.
5. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
6. Pregnant or need to breast feed during the study period.
7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
8. Brain surgery other than for resection of metastasis.
9. Previous brain radiotherapy.
10. Contraindication to SRS, WBRT, or MRI.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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John H. Sampson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Hamidreza Aliabadi, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
John P. Kirkpatrick, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
James E. Herndon, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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DUMC-PRO00004373
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000630239
Identifier Type: -
Identifier Source: secondary_id
Pro00004373
Identifier Type: -
Identifier Source: org_study_id
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