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| ID | Type | Description | Link |
|---|---|---|---|
| JT 9331 | Other Identifier | JeffTrial Number |
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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.
PRIMARY OBJECTIVES:
I. Assessment of neurocognitive function at months 4.
SECONDARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (SRS/SBRT, neurocognitive testing) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Assessment | Procedure | Undergo assessment of neurocognitive function |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenyin Shi, MD | Contact | (215) 955-6702 | wenyin.shi@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wenyin Shi, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Health New Jersey | Not yet recruiting | Sewell | New Jersey | 08080 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| Stereotactic Radiosurgery | Radiation | Undergo SRS |
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| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Baseline to up to 12 months |
| 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. | Baseline to up to 12 months |
| 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. | Up to 12 months |
| Local control as measured by magnetic resonance imaging | Will be measured by magnetic resonance imaging. | Up to 12 months |
| Progression free survival (PFS) | Each group will be evaluated using the Kaplan-Meier method. | Up to 12 months |
| Overall survival (OS) | Each group will be evaluated using the Kaplan-Meier method. | Up to 12 months |
| 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. | Up to 30 days after SRS |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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