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Metastatic Malignant Neoplasm in the BrainNCT03184038

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

A study testing Cognitive Assessment, Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Solid Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive Assessment, Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesUnited States
Study dates
21 Feb 2017to 30 Sep 2026
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

  • Pathologically proven solid tumor malignancy (except for small cell lung cancer [SCLC], germ cell tumor)
  • Karnofsky performance status >= 60
  • 1 to 10 brain metastases (mets) (no more than two lesions and/or cavities >= 3 cm in maximum diameter)
  • Maximum diameter of brain metastasis or resection cavity is 6 cm
  • Serum creatinine =< 3 mg/dL and creatinine clearance >= 30 ml/min
  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
Show all 9Show fewer
  • Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
  • Patient able to provide his/her own written informed consent and speak English

Who cannot join

  • Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
  • Prior brain surgery =< 14 days prior to enrollment
  • Planned chemotherapy during radiosurgery
  • Leptomeningeal metastases
  • Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
  • Pregnant women

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wenyin Shi, MD contact

(215) 955-6702

wenyin.shi@jefferson.edu

United States2 sites, 2 recruiting

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Wenyin Shi, MD, (215) 955-6702

    Recruiting

  • Jefferson Health New Jersey

    Sewell, New Jersey, 08080

    Karishma Kurowski, MPH, 856-341-5199, karishma.kurowski@jefferson.edu

    Tamara LaCouture, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assessment of neurocognitive function at months 4.

SECONDARY OBJECTIVES:

  1. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests.

II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).

III. Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).

IV. Assessment of local control, in brain control. V. Assessment of progression free survival (PFS), and overall survival (OS). VI. Assessment of side effects and toxicities.

OUTLINE:

Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.

After completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.

Being tested
Cognitive Assessment, Stereotactic Radiosurgery, Stereotactic Body Radiation Therapy, Quality-of-Life Assessment
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.

  • Cognitive AssessmentProcedure or surgery

    Undergo assessment of neurocognitive function

  • Stereotactic RadiosurgeryRadiation

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

    Undergo SRS

  • Stereotactic Body Radiation TherapyRadiation

    Also called SBRT, SABR, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT03184038
Study groupRoleWhat they receive
Supportive care (SRS/SBRT, neurocognitive testing)ExperimentalPatients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
Receives: Procedure: Cognitive Assessment; Radiation: Stereotactic Radiosurgery; Radiation: Stereotactic Body Radiation Therapy; Other: Quality-of-Life Assessment

What is being measured

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

  1. Neurocognitive function as measured by neurocognitive decline on a battery of tests

    The proportion of patients with neurocognitive decline at 4 months post stereotactic radiosurgery (SRS) treatment in each group will be estimated using the sample proportion with the corresponding two-sided 95% confidence interval. The determination of neurocognitive decline will be based on a battery of tests: Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.

    Measured: At 4 months

Secondary outcomes (7)

  1. Change in neurocognitive function as measured by neurocognitive decline on a battery of tests conducted by the primary investigator or a trained member of the clinical team

    Each patient will serve as his or her own control, and the relative decline in HVLT-R scores from baseline to pre-specified post-treatment internals will be defined as follows: ΔHVLTi = (HVLTB - HVLTF) ÷ HVLTB, where B = baseline and F = follow-up. A positive change indicates a decline in function. Comparison of HVLT-R DR results between control and different time points will be tested using the one-side Wilcoxon signed rank test with significance level of .05. The repeated measures of each neurocognitive test (HVLT-R, COWA, and TMT) and the health-related quality of life (HR-QOL) scale at 2, 4, 6, and 12 months will be analyzed using a linear mixed effects model. The dichotomous indicator of neurocognitive decline based on this battery of tests at 2, 4, 6, and 12 months will be analyzed using a repeated measures logistic regression model.

    Measured: Baseline to up to 12 months

  2. Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)

    Four subscales (symptom severity, symptom interference, neurologic factor, and cognitive factor score) as well as certain individual items (fatigue, neurologic factor items, and cognitive factor items) of the MDASI-BT will be analyzed. For discrete time point analyses, the change from baseline to each follow-up time point (2, 4, 6, and 12 months from the start of treatment) will be calculated and compared between treatment arms using a t-test or Wilcoxon-Mann-Whitney test, depending on the normality of the data.

    Measured: Baseline to up to 12 months

  3. Quality adjusted survival and health outcomes as measured by the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L)

    The Z-test will be used to test the hypothesis that the health outcomes in the 2 treatment groups is the same at different time points after initiation of treatment with a significance level of 0.05 and a 2-sided test.

    Measured: Up to 12 months

  4. Local control as measured by magnetic resonance imaging

    Will be measured by magnetic resonance imaging.

    Measured: Up to 12 months

  5. Progression free survival (PFS)

    Each group will be evaluated using the Kaplan-Meier method.

    Measured: Up to 12 months

  6. Overall survival (OS)

    Each group will be evaluated using the Kaplan-Meier method.

    Measured: Up to 12 months

  7. Incidence of adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0

    Descriptive analysis will be performed on the acute toxicity data. All estimates of rates (e.g., discontinuation rate and rates of other toxicities) will be presented with corresponding confidence intervals.

    Measured: Up to 30 days 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 posted12 Jun 2017
  2. Study start21 Feb 2017
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03184038
Sponsor's protocol ID
16D.651
Other IDs
JT 9331
Status last verified
May 2026
First submitted
5 Apr 2017
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Assessment, Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy in people with Metastatic Malignant Neoplasm in the Brain and Metastatic Malignant Solid Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 2 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 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: looking for participants now, as of the sponsor's last update on 22 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 2 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 Wenyin Shi, MD ((215) 955-6702, wenyin.shi@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurocognitive function as measured by neurocognitive decline on a battery of tests (time frame: At 4 months). 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 NCT03184038.

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 22 May 2026.

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