A Phase 2 interventional study of Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV in Brain Metastases, Adult, Brain Tumor - Metastatic and Brain Metastases From Non-small Cell Lung Cancer (NSCLC), sponsored by Ayal A. Aizer, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ayal A. Aizer, MD · Phase 2, Interventional, and Treatment
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.
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.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Ayal A. Aizer, MD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must have a proven solid with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or proven to be a meeting one of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0mm uncertainty margin
Radiation: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
1mm uncertainty margin
Radiation: Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV
Also known as: SRS, SRT
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).
Time frame: Diagnostic MRI to MRI on first day of treatment
Overall survival
Clinical parameter
Time frame: 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)
Time frame: 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.
Time frame: Duration of time on study (estimated 1 year)
Progression free survival
Clinical assessment of first progression after treatment
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Duration of time on study (estimated 1 year)
Time to local recurrence
Time from treatment to first appearance of local recurrence on radiographic assessment
Time frame: Duration of time on study (estimated 1 year)
Time to salvage craniotomy
Time from treatment to first use of craniotomy as salvage therapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline to 12 months after baseline
Plan to share: Undecided
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Ayal A. Aizer, MD