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The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.
Patients who have a brain metastasis surgically resected have very high local rates of disease relapse, and so the standard of care is to give either whole brain irradiation or stereotactic radiosurgery to the resection cavity in order to prevent disease recurrence. Stereotactic radiosurgery generally offers a more favorable side effect profile than whole brain irradiation, but targeting a surgical resection bed can be a challenge, as post surgical changes make it more difficult to distinguish residual tumor from scar, and much of the dose ends up being focused on the center of the resection cavity, where there are no substantial tumor cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery | Other | Subjects will receive stereotactic radiosurgery prior to resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | Radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate (LCR) at 6 Months | The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy. | At 6 months |
| Local Control Rate (LCR) at 12 Months | The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 12 months compared to the tumor volume at the start of radiotherapy. | At 12 months |
| Local Control Rate (LCR) at 24 Months | The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 24 months compared to the tumor volume at the start of radiotherapy. | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Overall Survival (OS) | The probability of patients being alive at 6 months after the beginning of treatment. | At 6 months |
| 12-month Overall Survival (OS) | The probability of patients being alive at 12 months after the beginning of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A Wilke, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside Radiation Oncology Department | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiosurgery | Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiosurgery | Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy |
| 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 | Local Control Rate (LCR) at 6 Months | The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 6 months |
|
|
Patients were monitored for Adverse Events for up to 60 days post treatment. Adverse events data were collected for 2 years, 10 months. Deaths were assessed for up to 55 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 | Stereotactic Radiosurgery | Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stadterman, MPH, CCRP, Clinical Research Manager | UPMC Hillman Cancer Center | 4126233272 | stadtermanbm@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2022 | Mar 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| At 12 months |
| 24-month Overall Survival (OS) | The probability of patients being alive at 24 months after the beginning of treatment. | At 24 months |
| Distant Intracranial Failure | The probability of new brain metastases at 6 months identified via magnetic resonance imaging. | At 6 months |
| Distant Intracranial Failure | The probability of new brain metastases at 12 months identified via magnetic resonance imaging. | At 12 months |
| Distant Intracranial Failure | The probability of new brain metastases at 24 months identified via magnetic resonance imaging. | At 24 months |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | At 6 months (1.5-month window) |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | At 6 months (3-month window) |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | At 12 months (1.5-month window) |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | At 12 months (3-month window) |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.. | At 24 months (1.5-month window) |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | At 24 months (3-month window) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Local Control Rate (LCR) at 12 Months | The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 12 months compared to the tumor volume at the start of radiotherapy. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 12 months |
|
|
|
| Primary | Local Control Rate (LCR) at 24 Months | The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 24 months compared to the tumor volume at the start of radiotherapy. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 24 months |
|
|
|
| Secondary | 6-month Overall Survival (OS) | The probability of patients being alive at 6 months after the beginning of treatment. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 6 months |
|
|
|
| Secondary | 12-month Overall Survival (OS) | The probability of patients being alive at 12 months after the beginning of treatment. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 12 months |
|
|
|
| Secondary | 24-month Overall Survival (OS) | The probability of patients being alive at 24 months after the beginning of treatment. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 24 months |
|
|
|
| Secondary | Distant Intracranial Failure | The probability of new brain metastases at 6 months identified via magnetic resonance imaging. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 6 months |
|
|
|
| Secondary | Distant Intracranial Failure | The probability of new brain metastases at 12 months identified via magnetic resonance imaging. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 12 months |
|
|
|
| Secondary | Distant Intracranial Failure | The probability of new brain metastases at 24 months identified via magnetic resonance imaging. | All patients who received radiotherapy. | Posted | Number | 95% Confidence Interval | proportion of patients | At 24 months |
|
|
|
| Secondary | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | All patients who received radiotherapy and completed required surveys. | Posted | Mean | Standard Deviation | score on a scale | At 6 months (1.5-month window) |
|
|
|
| Secondary | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | All patients who received radiotherapy and completed required surveys. | Posted | Mean | Standard Deviation | score on a scale | At 6 months (3-month window) |
|
|
|
| Secondary | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | All patients who received radiotherapy and completed required surveys. | Posted | Mean | Standard Deviation | score on a scale | At 12 months (1.5-month window) |
|
|
|
| Secondary | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | All patients who received radiotherapy and completed required surveys. | Posted | Mean | Standard Deviation | score on a scale | At 12 months (3-month window) |
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| Secondary | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.. | All patients who received radiotherapy and completed required surveys. | Posted | Mean | Standard Deviation | score on a scale | At 24 months (1.5-month window) |
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| Secondary | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life. | All patients who received radiotherapy and completed required surveys. | Posted | Mean | Standard Deviation | score on a scale | At 24 months (3-month window) |
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| 19 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |