Brain Metastases, AdultPhase 2NCT07132190
Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction
A Phase 2 study testing Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV in people with Brain Metastases, Adult and Brain Tumor - Metastatic, run by Ayal A. Aizer, MD at 1 site in United States.
Trial summary
The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult, Brain Tumor - Metastatic, Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2025to Sep 2029
- Phase
- Phase 2
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
- Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria:
- Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
- Abutment, to within 1.0cm, of a region of intracranial edema
- Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
- Proximity (within 5.0cm) to another source of physical displacement
- Age of at least 18 years
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- Karnofsky performance status of at least 60
- Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
- Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium
Who cannot join
- Participants who cannot tolerate a brain MRI
- Patients who cannot receive gadolinium
- Participants with end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
- Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study as well
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ayal A Aizer, MD, MHS, (617) 732-7560, aaaizer@partners.org
About this study
Official title: A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction
The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields.
Participants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation/radiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation/radiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.
Read the detailed description
Adaptively designed radiation, which adjusts a given radiation plan for real time changes in patient position or anatomy, has become a standard approach within many oncologic entities to combat the effect of shifts between simulation and treatment. Adaptively planned SRS/SRT with same day brain MRI and treatment delivery offers potential to quantify the impact of treatment planning time while also reducing margins and potentially improving rates of local recurrence and radiation necrosis. This trial aims to explore the viability of adaptively designed SRS/SRT with same day planning and treatment in combination with tighter planning margins in both controlling brain metastases locally and minimizing the risk of radiation necrosis in a phase 2 randomized study.
Participants will have a preliminary stereotactic treatment plan created from a diagnostic brain MRI indicating the need for treatment. The preliminary plan will undergo departmental-standard physics, therapy, and quality assurance checks, spanning a total of 1-2 weeks, after which the patient will return for treatment. On the day of treatment (SRS) or start of treatment (SRT), a repeat MRI brain will be performed for planning purposes on an MRI simulator. A synthetic computed tomography (CT) scan will be generated from the new MRI. The previously generated contours and plan will be adapted to the new MRI and the fused synthetic CT. Lastly, the treatment will be delivered.
The primary objective is to assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment.
An important secondary objective is to quantify local recurrence and radiation necrosis rates in patients treated with same day simulation and treatment, based on randomization to a PTV of 0mm or 1.0mm.
- Conditions
- Brain Metastases, Adult, Brain Tumor - Metastatic, Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Extra-cranial Solid Tumors
- Being tested
- Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
- Keywords
- Brain Mets, Brain Metastases, Brain-directed stereotactic radiation, Brain radiation, Volatile Brain Metastases, Intracranial lesion, SRS, SRT, RANO, PTV, Planning Target Volume, Local Recurrence, Radiation Necrosis, Adaptive, VMAT, Volumetric Modulated Arc Therapy, Margin, Volatile, Rapid, Growth
- Medical subject headings
- Brain Neoplasms, Margins of Excision, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTVRadiation
Also called SRS, SRT
Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
| Study group | Role | What they receive |
|---|---|---|
| 0mm PTV | Experimental | 0mm uncertainty margin Receives: Radiation: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV |
| 1mm PTV | Active comparator | 1mm uncertainty margin Receives: Radiation: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment.
Percentage of patients, based on clinical and radiographic assessment, in which the repeat same day/simulation MRI reveals tumor extending beyond a 1.0mm PTV margin of the plan developed on the diagnostic MRI (i.e. the percentage of patients for which the MRI obtained on the same or first day of treatment displays tumor extending 1.0mm beyond the extent of the tumor on the planning MRI).
Measured: Diagnostic MRI to MRI on first day of treatment
Secondary outcomes (16)
Overall survival
Clinical parameter
Measured: Duration of time on study (estimated 1 year)
Death due to neurologic disease progression
Clinical assessment via review of study visits and medical records indicating cause of death (neurologic versus non-neurologic)
Measured: Duration of time on study (estimated 1 year)
Performance status
Karnofsky performance status (KPS), assessed longitudinally. A higher score indicates better functional status and less dependence on others.
Measured: Duration of time on study (estimated 1 year)
Progression free survival
Clinical assessment of first progression after treatment
Measured: Duration of time on study (estimated 1 year)
Quality of life/symptom burden and interference
Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT). Assessed longitudinally.
Scored by calculating the mean of the 13 core symptom items and the mean of the 6 interference items. A 0-10 scoring scale is used, with 0 representing an item is not present and 10 representing the highest severity. An item rated 5 or higher may indicate a moderate-to-severe symptom or interference.
Measured: Duration of time on study (estimated 1 year)
Neurocognitive function via Hopkins Verbal Learning Test-Revised
Hopkins Verbal Learning Test-Revised (HVLT-R) scored by number of words recalled. Larger number represents better neurocognitive function. T and Z scores derived using number of words recalled
Measured: Baseline to 12 months after baseline
Time to detection of new brain metastases
Time from treatment to first appearance of new brain metastases on radiographic assessment
Measured: Duration of time on study (estimated 1 year)
Time to development of radiation necrosis
Time from treatment to first appearance of new necrosis on radiographic assessment
Measured: Duration of time on study (estimated 1 year)
Time to development of leptomeningeal disease
Time from treatment to first appearance of leptomeningeal disease on radiographic assessment
Measured: Duration of time on study (estimated 1 year)
Time to local recurrence
Time from treatment to first appearance of local recurrence on radiographic assessment
Measured: Duration of time on study (estimated 1 year)
Time to salvage craniotomy
Time from treatment to first use of craniotomy as salvage therapy
Measured: Duration of time on study (estimated 1 year)
Time to additional radiotherapeutic treatments after the initial course
Time from treatment to first use of additional radiotherapeutic treatments after the initial course
Measured: Duration of time on study (estimated 1 year)
Time to the development of seizures
Time from treatment to development of primary seizures on clinical assessment
Measured: Duration of time on study (estimated 1 year)
Neurocognitive function via Trail Making Test Part A and B (TMT)
Trail Making Test Part A and B (TMT) scored based on time to completion of assessment. Shorter time interval reflects better neurocognitive function
Measured: Baseline to 12 months after baseline
Neurocognitive function via Controlled Word Association Test (COWAT)
Controlled Word Association Test (COWAT) scored by number of words patient can produce in one minute. Larger number of words represents better neurocognitive function
Measured: Baseline to 12 months after baseline
Neurocogntive function via Mini Mental Status Examination (MMSE)
Mini Mental Status Examination (MMSE) scored by sum of components within assessment. Higher score represents better neurocognitive function.
Measured: Baseline to 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start30 Dec 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayal A. Aizer, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Varian, a Siemens Healthineers Company
- Responsible party
- Sponsor-investigator, Ayal A. Aizer, MD, Brigham and Women's Hospital
- Investigators
- Ayal A Aizer, MD, MHS, Principal investigator, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132190
- Sponsor's protocol ID
- 25-133
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided