Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cognitive Assessment

    Procedure/Surgery

    Undergo assessment of neurocognitive function

  • Stereotactic Radiosurgery

    Radiation

    Undergo SRS

  • Stereotactic Body Radiation Therapy

    Radiation

    Undergo SBRT

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Supportive care (SRS/SBRT, neurocognitive testing)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

Time frame
At 4 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Up to 12 months
4

Local control as measured by magnetic resonance imaging

Will be measured by magnetic resonance imaging.

Time frame
Up to 12 months

Other outcomes

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