Brain MetastasasesNCT07802353
A Study of Stereotactic Radiosurgery (SRS) in People With Brain Cancer Having Tumor Resection Surgery
A study testing Stereotactic Radiosurgery and Surgical Resection in people with Brain Metastasases, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to see if treating people's brain tumors with stereotactic radiosurgery (SRS) before tumor resection surgery will prevent cancer cells from spreading to other areas of the brain, including the fluid and lining around the brain, during surgery, and lead to better surgical outcomes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasases
- What is being tested?
- Stereotactic Radiosurgery and Surgical Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histologically or cytologically confirmed breast cancer, non-small cell lung cancer, melanoma, or gastrointestinal cancer. In malignancies for which tissue confirmation is not standard diagnostic practice (for example, hepatocellular carcinoma diagnosed by characteristic imaging), radiographic diagnosis consistent with standard of care is acceptable. In all cases, the intracranial lesion planned for resection undergoes pathologic examination as part of protocol-directed surgery.
- At least one intact brain metastasis is planned for surgical resection that has not previously received stereotactic radiosurgery or other focal radiotherapy, measuring 6 cm or less in diameter.
- No evidence of leptomeningeal disease based on clinical symptoms, MRI imaging of the brain or spinal cord, and/or lumbar puncture cytologic analysis.
- No prior SRS to the index BM planned for surgical resection. Prior SRS to non- index lesions is permitted, with approval from the principal investigator. The interval since prior cranial radiotherapy will be recorded. All clinically significant toxicities from prior radiotherapy must have resolved to grade 1 or lower (CTCAE); patients with unresolved symptomatic (grade 2 or higher) radiation necrosis, treatment-related enhancing treatment effect, or clinically significant cerebral edema attributable to prior cranial radiation are not eligible.
- No prior therapeutic craniotomy or craniectomy with biopsy.
- Age ≥ 18
- Karnofsky Performance Status (KPS) of ≥ 70 and anticipated survival of >1 year
- Ability to undergo contrast-enhanced MRI brain
Who cannot join
- Pregnant and/or breastfeeding
- Prior whole brain radiotherapy.
- Neurologic instability despite medical management, such that either the treating team or study investigators feel that urgent craniotomy without awaiting SRS is indicated.
- Judgment by the principal investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nelson Moss, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Luke Pike, MD, 212-639-8157
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Luke Pike, MD, 212-639-8157
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Luke Pike, MD, 201-775-7604
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Luke Pike, MD, 212-639-8157
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Luke Pike, MD, 212-639-8157
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Luke Pike, MD, 201-775-7604
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
Luke Pike, MD, 212-639-8157
About this study
Official title: PReoperative Dose Escalated Stereotactic radioSurgery for Resectable Brain Metastases (PRESS)
The researchers are doing this study to see if treating people's brain tumors with stereotactic radiosurgery (SRS) before tumor resection surgery will prevent cancer cells from spreading to other areas of the brain, including the fluid and lining around the brain, during surgery, and lead to better surgical outcomes and fewer complications after surgery (post-surgery complications). Only one brain tumor (the index tumor) will be treated with the study radiosurgery and then removed by surgery. If there are other brain tumors, they will not be removed by surgery in this study, although they may be treated separately with standard radiation if the doctor decides it is needed.
- Conditions
- Brain Metastasases
- Being tested
- Stereotactic Radiosurgery, Surgical Resection
- Keywords
- Escalated Stereotactic radioSurgery, 26-304
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Stereotactic Radiosurgery (SRS) to the index lesion will be delivered with standard of care technique at doses of 18Gy or 21Gy, for tumors >3cm and ≤3cm, respectively, in a single fraction.
Surgical ResectionProcedure or surgery
Patients will undergo standard-of-care surgical resection of the index lesion within 10 days of SRS, and no later than 21 days to accommodate operating room availability.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic RadioSurgery | Experimental | Patients will be seen by an attending radiation oncologist before receiving SRS. Standard of are history and physical will be obtained. An MRI brain with contrast will be performed within seven days of the CT simulation for SRS planning. Surgical resection of the index lesion is to be performed within 10 days of SRS, and no later than 21 days to accommodate operating room availability. Receives: Radiation: Stereotactic Radiosurgery; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
local failure
pachymeningeal disease, classical leptomeningeal disease, symptomatic radiation necrosis, or death from any cause.to a composite adverse endpoint that includes This endpoint will be measured from date of receipt of SRS. These events are combined because they represent the totality of clinically meaningful central nervous system failure after resection and adjuvant radiation, are competing and partly related processes, and individually occur too infrequently to power a single-arm study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start28 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke Pike, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802353
- Sponsor's protocol ID
- 26-304
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PReoperative Dose Escalated Stereotactic radioSurgery for Resectable Brain Metastases (PRESS)
- ClinicalTrials.gov ID
- NCT07802353
- Acronym / sponsor ID
- 26-304
- Conditions
- Brain Metastasases
- Keywords
- Escalated Stereotactic radioSurgery, 26-304
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to see if treating people's brain tumors with stereotactic radiosurgery (SRS) before tumor resection surgery will prevent cancer cells from spreading to other areas of the brain, including the fluid and lining around the brain, during surgery, and lead to better surgical outcomes and fewer complications after surgery (post-surgery complications). Only one brain tumor (the index tumor) will be treated with the study radiosurgery and then removed by surgery. If there are other brain tumors, they will not be removed by surgery in this study, although they may be treated separately with standard radiation if the doctor decides it is needed.
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 | Experimental | Radiation: Stereotactic Radiosurgery, Procedure: Surgical ResectionPatients will be seen by an attending radiation oncologist before receiving SRS. Standard of are history and physical will be obtained. An MRI brain with contrast will be performed within seven days of the CT simulation for SRS planning. Surgical resection of the index lesion is to be performed within 10 days of SRS, and no later than 21 days to accommodate operating room availability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed breast cancer, non-small cell lung cancer, melanoma, or gastrointestinal cancer. In malignancies for which tissue confirmation is not standard diagnostic practice (for example, hepatocellular carcinoma diagnosed by characteristic imaging), radiographic diagnosis consistent with standard of care is acceptable. In all cases, the intracranial lesion planned for resection undergoes pathologic examination as part of protocol-directed surgery.
- At least one intact brain metastasis is planned for surgical resection that has not previously received stereotactic radiosurgery or other focal radiotherapy, measuring 6 cm or less in diameter.
- No evidence of leptomeningeal disease based on clinical symptoms, MRI imaging of the brain or spinal cord, and/or lumbar puncture cytologic analysis.
- No prior SRS to the index BM planned for surgical resection. Prior SRS to non- index lesions is permitted, with approval from the principal investigator. The interval since prior cranial radiotherapy will be recorded. All clinically significant toxicities from prior radiotherapy must have resolved to grade 1 or lower (CTCAE); patients with unresolved symptomatic (grade 2 or higher) radiation necrosis, treatment-related enhancing treatment effect, or clinically significant cerebral edema attributable to prior cranial radiation are not eligible.
- No prior therapeutic craniotomy or craniectomy with biopsy.
Key exclusion criteria (4 listed)
- Pregnant and/or breastfeeding
- Prior whole brain radiotherapy.
- Neurologic instability despite medical management, such that either the treating team or study investigators feel that urgent craniotomy without awaiting SRS is indicated.
- Judgment by the principal investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
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 RadiosurgeryStereotactic Radiosurgery (SRS) to the index lesion will be delivered with standard of care technique at doses of 18Gy or 21Gy, for tumors >3cm and ≤3cm, respectively, in a single fraction. | Radiation | Stereotactic RadioSurgery |
| Surgical ResectionPatients will undergo standard-of-care surgical resection of the index lesion within 10 days of SRS, and no later than 21 days to accommodate operating room availability. | Procedure or surgery | Stereotactic RadioSurgery |
Primary outcome
local failure
Time frame: 1 year
pachymeningeal disease, classical leptomeningeal disease, symptomatic radiation necrosis, or death from any cause.to a composite adverse endpoint that includes This endpoint will be measured from date of receipt of SRS. These events are combined because they represent the totality of clinically meaningful central nervous system failure after resection and adjuvant radiation, are competing and partly related processes, and individually occur too infrequently to power a single-arm study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Nelson Moss, MD contact
Luke Pike, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Radiosurgery and Surgical Resection in people with Brain Metastasases, run by Memorial Sloan Kettering Cancer Center at 7 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luke Pike, MD, PhD (212-639-8157, pikel@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local failure (time frame: 1 year). 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 9 Sep 2026.