Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
NCT ID: NCT00983359
Last Updated: 2017-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2007-04-30
2012-08-31
Brief Summary
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PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases
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Detailed Description
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Primary
* To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.
Secondary
* To determine the overall survival rate at 6 months.
* To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
* To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
* To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.
OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.
After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (conformal stereotactic radiation therapy)
Patients undergo conformal stereotatic radiation
Radiation Therapy
Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Interventions
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Radiation Therapy
Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have cancer not originating in central nervous system (CNS)
* Karnofsky score of at least 60
* Given written consent
* At least 18 years of age
Exclusion Criteria
* Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Mario Ammirati
Principal Investigator
Principal Investigators
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Mario Ammirati, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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Ammirati M, Kshettry VR, Lamki T, Wei L, Grecula JC. A prospective phase II trial of fractionated stereotactic intensity modulated radiotherapy with or without surgery in the treatment of patients with 1 to 3 newly diagnosed symptomatic brain metastases. Neurosurgery. 2014 Jun;74(6):586-94; discussion 594. doi: 10.1227/NEU.0000000000000325.
Related Links
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The Jamesline
Other Identifiers
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NCI-2011-03139
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-06138
Identifier Type: -
Identifier Source: org_study_id
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