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Brain Metastases, AdultSIMTNCT02886572

SIMT Stereotactic Radiosurgery Outcomes Study

A study testing Stereotactic radiosurgery in people with Brain Metastases, Adult, run by Duke 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

The purpose of this study is to determine the effectiveness and efficiency of Single Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more brain metastases Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, Adult
What is being tested?
Stereotactic radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
25 Jan 2017to 30 Apr 2021
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

  • A contrast-enhanced MRI scan showing = or > 4 brain metastases.
  • Age >/=18 years of age.
  • KPS >/= 70
  • Patient must have a graded prosnostic score (GPA) score 0.5 or greater
  • Life expectancy of at least 3 months
  • Postoperative patients with resected brain metastases are eligible.
Show all 10Show fewer
  • Largest lesion < 4cm diameter
  • Must be a candidate for MRI imaging
  • Previous cranial stereotactic radiosurgery (SRS) or whole brain radiation therapy (WBRT) is allowed if > 3 months prior to SIMT
  • Must be capable of providing informed consent

Who cannot join

  • Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
  • Metastases within 2 mm of the optic apparatus
  • Patients unable to obtain MRI
  • Evidence of leptomeningeal disease
  • Greater than 10 brain metastases
  • Pregnant women are excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Outcome in Patients With 4 or More Brain Metastases Treated With Single-Isocenter, Multi-Target (SIMT) Stereotactic Radiosurgery: A Prospective Single-arm Study in Adults With Brain Metastases

The purpose of this study is to determine the effectiveness and efficiency of Single Isocenter Multi-target Stereotactic Radiosurgery (SIMT SRS) in patients with four or more brain metastases

Read the detailed description

Forty patients with four or more brain metastases will be enrolled prior to radiosurgery. A planning MRI brain scan will be performed with GD-DPTA within one week prior to radiosurgery, per the standard of care. Neurocognitive (Mini-Mental Status Examination (MMSE), Trail-making test A\&B, Hopkins Learning Verbal (HVLT)) and functional assessment of cancer therapy-brain (FACT- Br) will be obtained prior to radiosurgery. Dose will be prescribed to the maximum isodose line encompassing the resulting PTV using the dose guidelines as described below.

The primary endpoint will be the proportion of patients who live longer than predicted based on the diagnosis-specific GPA score. The Kaplan-Meier estimator will be used to describe the survival of all patients treated with SIMT SRS. Secondary endpoints will be the rate of recurrence at the treated metastases sites, the rate of new brain metastases at a site different from the SRS-treated metastases sites, the rate of death due to neurological causes, and the prevalence of significant adverse events. Exploratory endpoints include change over time in neurocognition and quality of life, quantification of dosimetric measures, the rate of salvage therapy, the rate of radionecrosis at the SRS treatment sites, and the rate and intensity of steroid-usage post-SRS.

All patients will be evaluated for neurocognitive function via MMSE, HVLT, and Trail-making tests A \& B, quality of life via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. These evaluations will be done at regular follow-up evaluations or when local recurrence is suspected on the basis of symptoms. Distant recurrence is defined as the appearance of new brain metastases at a site different from that of the original metastases. Recurrence will further be defined as a new area of enhancement that measures greater than 5 millimeters in the axial plane on MRI. The length of time to recurrence of the original brain metastases will be calculated from the date of the brain metastases radiosurgery to the date that a recurrence was detected by MRI. Patients with suspected recurrent tumor and/or who are symptomatic may undergo a stereotactic biopsy to evaluate for radionecrosis versus recurrent brain metastases, as is standard of care.

Being tested
Stereotactic radiosurgery
Medical subject headings
Brain Neoplasms

What participants receive

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

  • Stereotactic radiosurgeryRadiation

    Also called SRS

    Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery

Study groups in NCT02886572
Study groupRoleWhat they receive
Stereotactic RadiosurgeryExperimentalAll subjects will receive stereotactic radiosurgery(SRS) following the RTOG Stereotactic Radiotherapy Guidelines available at http://dx.doi.org/10.1016/j.prro.2011.06.014
Receives: Radiation: Stereotactic radiosurgery

What is being measured

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

  1. Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score

    Calculated from the time of protocol Stereotactic RadioSurgery (SRS). The GPA incorporates four factors: age, KPS (Karnofsky Performance Score), ECM (extracranial metastases) and number of BM (brain metastases). Each factor is given a score of 0, 0.5 or 1.0 and GPA is calculated as a sum score of all four factors. The GPA has four groups: the GPA 0-1 with median survival of 2.6 months; GPA 1.5-2.5 with survival of 3.8 months; GPA 3 with median survival of 6.9 months and GPA 3.5-4.0 with the best median survival of 11 months.

    Measured: Up to 24 months after SRS

Secondary outcomes (4)

  1. Number of Participants Who Experience Local Brain Recurrence Within 1 Year of SIMT SRS Treatment

    Local recurrence of brain metastases is based on serial MRIs every 3 months and estimated by Kaplan-Meier analysis.

    Measured: Up to 12 months after SRS

  2. Number of Participants Who Are Dead Within 1 Year of SIMT SRS Treatment Due to Neurologic Reasons

    Time to neurologic death is defined as the time between initiation of SIMT SRS and death due to neurologic causes and is estimated using Kaplan-Meier analysis.

    Measured: Up to 12 months after SRS

  3. Number of Participants Who Experience a New Brain Metastasis at a Site Different From the Original Brain Metastasis Site 1 Year After SIMT SRS Treatment

    Distant recurrence of brain metastases is based on serial MRIs every 3 months and estimated by Kaplan-Meier analysis.

    Measured: Up to 12 months after SRS

  4. Number of Participants Who Experience Grade 3, 4, or 5 Neurologic Adverse Events Attributable to SIMT SRS

    Adverse Events only included those that were deemed by the PI to be related to the SIMT SRS treatment.

    Measured: Up to 12 months after SRS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2016 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

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
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02886572
Sponsor's protocol ID
Pro00075429
Acronym
SIMT
Status last verified
May 2022
First submitted
29 Aug 2016
Last updated
1 Jun 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim GJ, Buckley ED, Herndon JE, Allen KJ, Dale TS, Adamson JD, Lay L, Giles WM, Rodrigues AE, Wang Z, Kelsey CR, Torok JA Jr, Chino JP, Fecci PE, Sampson JH, Anders CK, Floyd SR, Yin FF, Kirkpatrick JP. Outcomes in Patients With 4 to 10 Brain Metastases Treated With Dose-Adapted Single-Isocenter Multitarget Stereotactic Radiosurgery: A Prospective Study. Adv Radiat Oncol. 2021 Jul 23;6(6):100760. doi: 10.1016/j.adro.2021.100760. eCollection 2021 Nov-Dec.

    PubMed 34934856

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic radiosurgery in people with Brain Metastases, Adult, run by Duke 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 10 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 1 Jun 2022. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2022). 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?

Number of Participants Who Live Longer Than Predicted According to the Graded Prognostic Assessment (GPA) Score (time frame: Up to 24 months after SRS). 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 NCT02886572, 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 1 Jun 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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