Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00814463|
Recruitment Status : Terminated (Early analysis indicated SRS not as beneficial post-op as pre-op)
First Posted : December 24, 2008
Results First Posted : May 7, 2013
Last Update Posted : August 6, 2014
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Behavioral: MMSE Behavioral: QOL via FACT-Br Procedure: MRI Radiation: Post-operative SRS||Phase 2|
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Active Comparator: 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.
Neurocognitive function via MMSE done every 3 months for length of study.
Other Name: Mini-Mental Status ExamBehavioral: QOL via FACT-Br
Quality of Life via FACT-BR every 3 months for length of study.
Other Names:Procedure: MRI
MRI done every 3 months for the length of the study.
Other Name: Magnetic Resonance ImagineRadiation: Post-operative SRS
Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.
Other Name: SRS
- Recurrence Rate at the Surgical Site as Measured by MRI [ Time Frame: 12 months ]The number of months for local recurrence via MRI
- Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery [ Time Frame: 12 months ]
- Rate of New Brain Metastases Outside of the Adjuvant SRS Site [ Time Frame: 12 months ]
- Quality of Life as Measured by the FACT-Br Subscales [ Time Frame: Every 3 months for 12 months ]
- Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam [ Time Frame: Every 3 months for 12 months. ]
- Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms) [ Time Frame: 12 months ]
- Rate of Death Due to Neurologic Causes [ Time Frame: 12 months ]
- Overall Survival [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814463
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||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|