Metastatic Malignant Neoplasm to BrainNCT01705548
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
A study testing Hypofractionated Radiosurgery in people with Metastatic Malignant Neoplasm to Brain and Unspecified Adult Solid Tumor, Protocol Specific, run by Emory University at 2 sites in United States.
Trial summary
This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm to Brain, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Hypofractionated Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Sep 2012to 18 Sep 2023
- 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
- Pathologic proven diagnosis of solid tumor malignancy
- One brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.)
- Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥ 70%
Who cannot join
- Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy
- RPA class III (KPS < 70%)
- Brain metastasis or resection cavity volume < 3 cm or > 6 cm
- Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
- Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or cerebrospinal fluid (CSF) cytology
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- Current pregnancy
- More than 8 weeks between resection and radiosurgical procedure
- Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic apparatus (optic nerves and chiasm)
- Inability to undergo MRI evaluation for treatment planning and follow-up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis
This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVE:
To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week.
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks.
After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.
- Being tested
- Hypofractionated Radiosurgery
- Keywords
- Brain metastasis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RadiosurgeryRadiation
Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiosurgery | Experimental | HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment. Receives: Radiation: Hypofractionated Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Hypofractionated Radiosurgery Defined as the Highest Dose Level Where a Grade 3 or Greater With an Attribution Score of ≥ 3 Develops in ≤ 2 of 6 Patients in a Dose Group
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Measured: 4 months
Percentage of Participants With Neurologic Toxicity/Radiation Necrosis Possibly Due to Treatment, Graded According to the CTCAE Version 4.03 as Grade 2 or Greater.
Number
Measured: Up to 2 years
Secondary outcomes (6)
Local Control; Lack of Progression of Disease in Resection Cavity as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
Cumulative incidences of local brain progression will be calculated by Kaplan-Meier method with 95% CI.
Measured: 24 months
Intercranial Progression Free Survival: Lack of Progression of Disease in Surrounding Brain as Defined by RECIST Criteria
Percentage of patients with distant brain progression at the defined time point, with each individual patient's time to progression calculated by Kaplan-Meier method with 95% CI.
Measured: 12 months
Freedom From Failure/Progression Free Survival
Measured: Up to 2 years
Overall Survival (OS): Death From Any Cause
The median of OS time with 95% CI will be calculated by Kaplan-Meier method.
Measured: Up to 2 years
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Scores
Percentage of Participants with a Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Z-Score of ≤ -1.
Measured: Up to 4 months
Quality of Life (QOL) Outcomes: Using the Quality of Life Questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
Patients completed the FACT-BR at baseline and in follow-up. Responses are summed at each encounter to create a score. Total assessments combine scores range from 0-200. The higher the score, the better the QOL. Change from baseline to 4-month follow-up was calculated. A notable change is defined 20 point or greater increase or decrease in total score from baseline to 4-month follow-up score.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study start24 Sep 2012
- Primary completion11 Apr 2023
- Study completion18 Sep 2023
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 Metastatic Malignant Neoplasm to BrainStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bree Eaton, Emory University
- Investigators
- Bree Eaton, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705548
- Sponsor's protocol ID
- IRB00055063
- Other IDs
- NCI-2012-01933, RAD2156-11, P30CA138292
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2012
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis
- ClinicalTrials.gov ID
- NCT01705548
- Acronym / sponsor ID
- IRB00055063
- Keywords
- Brain metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 24 Sep 2012 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVE:
To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week.
OUTLINE: This is a dose-escalation study.
Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks.
After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiosurgery | Experimental | Radiation: Hypofractionated RadiosurgeryHR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm. Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologic proven diagnosis of solid tumor malignancy
- One brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.)
- Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥ 70%
Key exclusion criteria (10 listed)
- Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy
- RPA class III (KPS < 70%)
- Brain metastasis or resection cavity volume < 3 cm or > 6 cm
- Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)
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 |
|---|---|---|
| Hypofractionated RadiosurgeryRadiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week. | Radiation | Hypofractionated Radiosurgery |
Primary outcome
Maximum Tolerated Dose (MTD) of Hypofractionated Radiosurgery Defined as the Highest Dose Level Where a Grade 3 or Greater With an Attribution Score of ≥ 3 Develops in ≤ 2 of 6 Patients in a Dose Group
Time frame: 4 months
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Percentage of Participants With Neurologic Toxicity/Radiation Necrosis Possibly Due to Treatment, Graded According to the CTCAE Version 4.03 as Grade 2 or Greater.
Time frame: Up to 2 years
Number
6 secondary outcomes
Local Control; Lack of Progression of Disease in Resection Cavity as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
Time frame: 24 months
Intercranial Progression Free Survival: Lack of Progression of Disease in Surrounding Brain as Defined by RECIST Criteria
Time frame: 12 months
Freedom From Failure/Progression Free Survival
Time frame: Up to 2 years
Overall Survival (OS): Death From Any Cause
Time frame: Up to 2 years
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Scores
Time frame: Up to 4 months
Quality of Life (QOL) Outcomes: Using the Quality of Life Questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bree Eaton, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiosurgery in people with Metastatic Malignant Neoplasm to Brain and Unspecified Adult Solid Tumor, Protocol Specific, run by Emory University at 2 sites 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 3 inclusion and 10 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 7 May 2026). 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?
Maximum Tolerated Dose (MTD) of Hypofractionated Radiosurgery Defined as the Highest Dose Level Where a Grade 3 or Greater With an Attribution Score of ≥ 3 Develops in ≤ 2 of 6 Patients in a Dose Group (time frame: 4 months). The study lists 2 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 7 May 2026.