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Metastatic Malignant Neoplasm in the BrainEarly Phase 1NCT04895592

Radiosurgery Before Surgery for the Treatment of Brain Metastases

A Early Phase 1 study testing Dexamethasone, Resection and Stereotactic Radiosurgery in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Solid Neoplasm, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone, Resection and Stereotactic Radiosurgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
20 Jul 2021to 4 Mar 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • Age >= 18 years
  • Prior or suspected diagnosis of malignancy
  • Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy > 12 weeks as determined by the investigator
  • Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
Show all 9Show fewer
  • Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions
  • Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
  • Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy

Who cannot join

  • Patients on any immunosuppressive medication other than dexamethasone
  • Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive
  • Pregnant or nursing women are excluded
  • Prior whole brain radiotherapy or SRS to the same site planned for surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: A Two Arm Pilot Study

This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis.

SECONDARY OBJECTIVES:

  1. To evaluate the immune niche in brain metastasis following SRS in the presence of low or high dose dexamethasone.

II. To evaluate the impact of pre-operative SRS on survival outcomes.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM A: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone orally (PO) or intravenously (IV) for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.

ARM B: Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.

After completion of study intervention, patients are followed up for 120 days, and then every 12 weeks thereafter.

Being tested
Dexamethasone, Resection, Stereotactic Radiosurgery
Medical subject headings
Brain Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO or IV

  • ResectionProcedure or surgery

    Also called Surgical Resection

    Undergo surgical resection

  • Stereotactic RadiosurgeryRadiation

    Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy

    Undergo SRS

Study groups in NCT04895592
Study groupRoleWhat they receive
Arm A (SRS, low dose dexamethasone, surgery)ExperimentalPatients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
Receives: Drug: Dexamethasone; Procedure: Resection; Radiation: Stereotactic Radiosurgery
Arm B (SRS, high dose dexamethasone, surgery)ExperimentalPatients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
Receives: Procedure: Resection; Radiation: Stereotactic Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events grade 3 or greater

    Evaluated using Common Terminology Criteria for Adverse Events. Tolerability of this regimen will be defined as < 33% of patients develop grade > 3 at 4 months. Adverse events will be summarized descriptively using frequencies and percentages.

    Measured: At 4 months post-treatment

Secondary outcomes (4)

  1. Density of immune niche in brain metastases

    Niche density will be assessed by immunofluorescence as described above. It will be summarized descriptively as the percent of tumor occupied by immune niche for each treatment arm, and will be compared between Arms A and B using a two-sample t-test or non-parametric equivalent, such as Mann-Whitney U test.

    Measured: Up to 2 years

  2. Time to local recurrence (LR)

    LR will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median LR will be estimated using the Brookmeyer-Crowley approach.

    Measured: From pre-operative stereotactic radiosurgery (SRS) to intracranial progression at the treated site, assessed up to 2 years

  3. Time to anywhere brain failure (ABF)

    ABF will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median TBF will be estimated using the Brookmeyer-Crowley approach.

    Measured: From preoperative SRS to intracranial progression at any site within the brain, assessed up to 2 years

  4. Overall survival (OS)

    OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated using the Brookmeyer-Crowley approach.

    Measured: From pre-operative SRS initiation to death, assessed 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.

  1. First posted20 May 2021
  2. Study start20 Jul 2021
  3. Primary completion9 Sep 2023
  4. Study completion4 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895592
Sponsor's protocol ID
STUDY00001896
Other IDs
NCI-2021-02761, STUDY00001896, RAD5234-21, P30CA138292
Status last verified
May 2026
First submitted
17 May 2021
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jansen CS, Pagadala MS, Cardenas MA, Prabhu RS, Goyal S, Zhou C, Chappa P, Vo BT, Ye C, Hopkins B, Zhong J, Klie A, Daniels T, Admassu M, Green I, Pfister NT, Neill SG, Switchenko JM, Prokhnevska N, Hoang KB, Torres MA, Logan S, Olson JJ, Nduom EK, Del Balzo L, Patel K, Burri SH, Asher AL, Wilkinson S, Lake R, Kesarwala AH, Higgins KA, Patel P, Dhere V, Sowalsky AG, Carter H, Khan MK, Kissick H, Buchwald ZS. Pre-operative stereotactic radiosurgery and peri-operative dexamethasone for resectable brain metastases: a two-arm pilot study evaluating clinical outcomes and immunological correlates. Nat Commun. 2024 Oct 14;15(1):8854. doi: 10.1038/s41467-024-53034-6.

    PubMed 39402027

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dexamethasone, Resection and Stereotactic Radiosurgery in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Solid Neoplasm, run by Emory University 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 9 inclusion and 6 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 14 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 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of adverse events grade 3 or greater (time frame: At 4 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895592, which also lists 1 linked publication.

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 14 May 2026.

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