An interventional study of Stereotactic Radiosurgery in Malignant Neoplasm Brain, sponsored by Christopher Wilke. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Christopher Wilke · Not applicable, Interventional, and Treatment
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Christopher Wilke is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive stereotactic radiosurgery prior to resection
Radiation: Stereotactic Radiosurgery
Radiation therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: At 24 months
6-month Overall Survival (OS)
The probability of patients being alive at 6 months after the beginning of treatment.
Time frame: At 6 months
12-month Overall Survival (OS)
The probability of patients being alive at 12 months after the beginning of treatment.
Time frame: At 12 months
24-month Overall Survival (OS)
The probability of patients being alive at 24 months after the beginning of treatment.
Time frame: At 24 months
Distant Intracranial Failure
The probability of new brain metastases at 6 months identified via magnetic resonance imaging.
Time frame: At 6 months
Distant Intracranial Failure
The probability of new brain metastases at 12 months identified via magnetic resonance imaging.
Time frame: At 12 months
Distant Intracranial Failure
The probability of new brain metastases at 24 months identified via magnetic resonance imaging.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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..
Time frame: 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.
Time frame: At 24 months (3-month window)
| Milestone | Stereotactic Radiosurgery |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
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.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| Local Control Rate (LCR) at 6 Months | 0.817 (0.669 to 0.997) |
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.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| Local Control Rate (LCR) at 12 Months | 0.817 (0.669 to 0.997) |
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.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| Local Control Rate (LCR) at 24 Months | 0.749 (0.579 to 0.973) |
The probability of patients being alive at 6 months after the beginning of treatment.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| 6-month Overall Survival (OS) | 0.708 (0.548 to 0.916) |
The probability of patients being alive at 12 months after the beginning of treatment.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| 12-month Overall Survival (OS) | 0.625 (0.458 to 0.852) |
The probability of patients being alive at 24 months after the beginning of treatment.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| 24-month Overall Survival (OS) | 0.500 (0.335 to 0.746) |
The probability of new brain metastases at 6 months identified via magnetic resonance imaging.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| Distant Intracranial Failure | 0.689 (0.521 to 0.912) |
The probability of new brain metastases at 12 months identified via magnetic resonance imaging.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| Distant Intracranial Failure | 0.632 (0.455 to 0.877) |
The probability of new brain metastases at 24 months identified via magnetic resonance imaging.
| proportion of patients | Stereotactic Radiosurgery |
|---|---|
| Distant Intracranial Failure | 0.502 (0.317 to 0.796) |
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.
| score on a scale | Stereotactic Radiosurgery |
|---|---|
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 139.878 ± 20.59528024 |
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.
| score on a scale | Stereotactic Radiosurgery |
|---|---|
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 142.1581538 ± 23.8429411 |
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.
| score on a scale | Stereotactic Radiosurgery |
|---|---|
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 141.0952857 ± 26.95376082 |
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.
| score on a scale | Stereotactic Radiosurgery |
|---|---|
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 143.3974615 ± 23.28519091 |
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..
| score on a scale | Stereotactic Radiosurgery |
|---|---|
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 167 ± NA |
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.
| score on a scale | Stereotactic Radiosurgery |
|---|---|
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 150.1484545 ± 23.94648714 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stereotactic Radiosurgery | 19/24 (79.2%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Stereotactic Radiosurgery |
|---|---|
| Mean | 65.33333 ± 8.6359 |
| Sex: Female, Male(Participants) | Stereotactic Radiosurgery |
|---|---|
| Female | 12 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Stereotactic Radiosurgery |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Stereotactic Radiosurgery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Christopher Wilke