Malignant Neoplasm Brain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONStereotactic Radiosurgery
Radiation therapy
Sponsors
Christopher Wilke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Life expectancy of at least 12 weeks * Karnofsky performance status of at least 50 * No contraindications to MRI scanning with intravenous contrast. * MRI scan consistent with brain metastasis as per radiology report. * Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension. * Patients must have an extra-cranial primary tumor diagnosis. * Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain. * Additional lesions will each be treated with stereotactic radiosurgery. * Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection * Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts
Exclusion criteria
* Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus. * Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus. * More than four additional diagnosed brain metastases. * Contraindication to general anesthesia. * Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS. * Primary brain tumor. * Contraindication to MRI scans or intravenous contrast. * Pregnant and breast-feeding females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Control Rate (LCR) at 6 Months | 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. |
| Local Control Rate (LCR) at 12 Months | 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. |
| Local Control Rate (LCR) at 24 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Intracranial Failure | At 6 months | The probability of new brain metastases at 6 months identified via magnetic resonance imaging. |
| 6-month Overall Survival (OS) | At 6 months | The probability of patients being alive at 6 months after the beginning of treatment. |
| Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | At 6 months (1.5-month window) | 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. |
| 12-month Overall Survival (OS) | At 12 months | The probability of patients being alive at 12 months after the beginning of treatment. |
| 24-month Overall Survival (OS) | At 24 months | The probability of patients being alive at 24 months after the beginning of treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stereotactic Radiosurgery Subjects will receive stereotactic radiosurgery prior to resection
Stereotactic Radiosurgery: Radiation therapy | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Stereotactic Radiosurgery |
|---|---|
| Age, Continuous | 65.33333 years STANDARD_DEVIATION 8.6359 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
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.
Time frame: At 12 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Local Control Rate (LCR) at 12 Months | 0.817 proportion of patients |
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.
Time frame: At 24 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Local Control Rate (LCR) at 24 Months | 0.749 proportion of patients |
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.
Time frame: At 6 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Local Control Rate (LCR) at 6 Months | 0.817 proportion of patients |
Secondary
12-month Overall Survival (OS)
The probability of patients being alive at 12 months after the beginning of treatment.
Time frame: At 12 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | 12-month Overall Survival (OS) | 0.625 proportion of patients |
Secondary
24-month Overall Survival (OS)
The probability of patients being alive at 24 months after the beginning of treatment.
Time frame: At 24 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | 24-month Overall Survival (OS) | 0.500 proportion of patients |
Secondary
6-month Overall Survival (OS)
The probability of patients being alive at 6 months after the beginning of treatment.
Time frame: At 6 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | 6-month Overall Survival (OS) | 0.708 proportion of patients |
Secondary
Distant Intracranial Failure
The probability of new brain metastases at 12 months identified via magnetic resonance imaging.
Time frame: At 12 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Distant Intracranial Failure | 0.632 proportion of patients |
Secondary
Distant Intracranial Failure
The probability of new brain metastases at 6 months identified via magnetic resonance imaging.
Time frame: At 6 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Distant Intracranial Failure | 0.689 proportion of patients |
Secondary
Distant Intracranial Failure
The probability of new brain metastases at 24 months identified via magnetic resonance imaging.
Time frame: At 24 months
Population: All patients who received radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Radiosurgery | Distant Intracranial Failure | 0.502 proportion of patients |
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.
Time frame: At 6 months (1.5-month window)
Population: All patients who received radiotherapy and completed required surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stereotactic Radiosurgery | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 139.878 score on a scale | Standard Deviation 20.59528024 |
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.
Time frame: At 6 months (3-month window)
Population: All patients who received radiotherapy and completed required surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stereotactic Radiosurgery | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 142.1581538 score on a scale | Standard Deviation 23.8429411 |
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.
Time frame: At 12 months (1.5-month window)
Population: All patients who received radiotherapy and completed required surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stereotactic Radiosurgery | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 141.0952857 score on a scale | Standard Deviation 26.95376082 |
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.
Time frame: At 12 months (3-month window)
Population: All patients who received radiotherapy and completed required surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stereotactic Radiosurgery | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 143.3974615 score on a scale | Standard Deviation 23.28519091 |
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..
Time frame: At 24 months (1.5-month window)
Population: All patients who received radiotherapy and completed required surveys.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stereotactic Radiosurgery | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 167 score on a scale |
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.
Time frame: At 24 months (3-month window)
Population: All patients who received radiotherapy and completed required surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stereotactic Radiosurgery | Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN) | 150.1484545 score on a scale | Standard Deviation 23.94648714 |