Malignant Neoplasm BrainNCT02514915
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
A study testing Stereotactic Radiosurgery in people with Malignant Neoplasm Brain, run by Christopher Wilke at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm Brain
- What is being tested?
- Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Radiation Oncology Department
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
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.
Read the 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.
- Conditions
- Malignant Neoplasm Brain
- Being tested
- Stereotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery | Other | Subjects will receive stereotactic radiosurgery prior to resection Receives: Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 24 months
Secondary outcomes (12)
6-month Overall Survival (OS)
The probability of patients being alive at 6 months after the beginning of treatment.
Measured: At 6 months
12-month Overall Survival (OS)
The probability of patients being alive at 12 months after the beginning of treatment.
Measured: At 12 months
24-month Overall Survival (OS)
The probability of patients being alive at 24 months after the beginning of treatment.
Measured: At 24 months
Distant Intracranial Failure
The probability of new brain metastases at 6 months identified via magnetic resonance imaging.
Measured: At 6 months
Distant Intracranial Failure
The probability of new brain metastases at 12 months identified via magnetic resonance imaging.
Measured: At 12 months
Distant Intracranial Failure
The probability of new brain metastases at 24 months identified via magnetic resonance imaging.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: At 24 months (3-month window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study start1 Dec 2016
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Neoplasm BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Wilke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Wilke, University of Pittsburgh
- Investigators
- Christopher A Wilke, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514915
- Sponsor's protocol ID
- HCC 14-150
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2015
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
- ClinicalTrials.gov ID
- NCT02514915
- Acronym / sponsor ID
- HCC 14-150
- Conditions
- Malignant Neoplasm Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Christopher WilkeUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery | Other | Radiation: Stereotactic RadiosurgerySubjects will receive stereotactic radiosurgery prior to resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiosurgeryRadiation therapy | Radiation | Stereotactic Radiosurgery |
Primary outcome
Local Control Rate (LCR) at 6 Months
Time frame: 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
Time frame: 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
Time frame: 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.
12 secondary outcomes
6-month Overall Survival (OS)
Time frame: At 6 months
12-month Overall Survival (OS)
Time frame: At 12 months
24-month Overall Survival (OS)
Time frame: At 24 months
Distant Intracranial Failure
Time frame: At 6 months
Distant Intracranial Failure
Time frame: At 12 months
Distant Intracranial Failure
Time frame: At 24 months
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Time frame: At 6 months (1.5-month window)
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Time frame: At 6 months (3-month window)
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Time frame: At 12 months (1.5-month window)
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Time frame: At 12 months (3-month window)
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Time frame: At 24 months (1.5-month window)
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)
Time frame: At 24 months (3-month window)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Malignant Neoplasm Brain
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher A Wilke, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery in people with Malignant Neoplasm Brain, run by Christopher Wilke at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control Rate (LCR) at 6 Months (time frame: At 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.