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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-PRO00004373 | Other Identifier | DUHS IRB | |
| CDR0000630239 |
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Early analysis indicated SRS not as beneficial post-op as pre-op
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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 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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-operative SRS | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMSE | Behavioral | Neurocognitive function via MMSE done every 3 months for length of study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate at the Surgical Site as Measured by MRI | The number of months for local recurrence via MRI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery | 12 months | |
| Rate of New Brain Metastases Outside of the Adjuvant SRS Site | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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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 Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
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Patients were recruited from the Duke Comprehensive Cancer Center from 6/12/2008 - 6/5/2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Recurrence Rate at the Surgical Site as Measured by MRI | The number of months for local recurrence via MRI | Posted | Number | Months | 12 months |
|
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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 | 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. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study. |
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| 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 |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D006304 | Health Status |
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| QOL via FACT-Br | Behavioral | Quality of Life via FACT-BR every 3 months for length of study. |
|
|
| MRI | Procedure | MRI done every 3 months for the length of the study. |
|
|
| Post-operative SRS | Radiation | Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. |
|
|
| Quality of Life as Measured by the FACT-Br Subscales |
| Every 3 months for 12 months |
| Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam | 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) | 12 months |
| Rate of Death Due to Neurologic Causes | 12 months |
| Overall Survival | 12 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Rate of New Brain Metastases Outside of the Adjuvant SRS Site | Data not collected due to subject withdrawal. | Posted | 12 months |
|
|
| Secondary | Quality of Life as Measured by the FACT-Br Subscales | Data not collected due to subject withdrawal. | Posted | Every 3 months for 12 months |
|
|
| Secondary | Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam | Data not collected due to subject withdrawal. | Posted | Every 3 months for 12 months. |
|
|
| Secondary | Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms) | Data not collected due to subject withdrawal. | Posted | 12 months |
|
|
| Secondary | Rate of Death Due to Neurologic Causes | Data not collected due to subject withdrawal. | Posted | 12 months |
|
|
| Secondary | Overall Survival | Data not collected due to subject withdrawal. | Posted | 12 months |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
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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 |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |