Assessment of Neurocognitive Function in Patients With Multiple Brain Metastases Undergoing Stereotactic Radiosurgery or Stereotactic Body Radiation Therapy
Study Details
Study Description
Brief 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). Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
- Assessment of neurocognitive function at months 4.
SECONDARY OBJECTIVES:
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Assessment of neurocognitive function at months 2, 6, and 12 as measured by neurocognitive decline on a battery of tests.
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Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).
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Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Assessment of neurocognitive function Patients undergo assessment of neurocognitive function at baseline and at 2, 4, 6, and 12 months after undergoing standard of care Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiation Therapy (SBRT) |
Procedure: Cognitive Assessment
Undergo assessment of neurocognitive function of subjects with 1-4 metastases vs 5-10 metastases
Radiation: Stereotactic Radiosurgery
Undergo standard of care (SRS) Stereotactic Radiosurgery
Other Names:
Radiation: Stereotactic Body Radiation Therapy
Undergo standard of care (SBRT) Stereotactic Body Radiation Therapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall [At 4 months]
Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.
- Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall [At 4 months]
Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.
- Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recognition [At 4 months]
Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recognition. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.
- Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Trail Making Test (TMT) Parts A [At 4 months]
Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for 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.
Secondary Outcome Measures
- 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 [Baseline to up to 12 months]
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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically proven solid tumor malignancy (except for small cell lung cancer [SCLC], germ cell tumor)
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Karnofsky performance status >= 60
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1 to 10 brain mets (no more than two lesions and/or cavities >= 3 cm in maximum diameter)
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Maximum diameter of brain metastasis or resection cavity is 6 cm
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Serum creatinine =< 3 mg/dL and creatinine clearance >= 30 ml/min
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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
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Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
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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
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Patient able to provide his/her own written informed consent and speak English
Exclusion Criteria:
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Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
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Prior brain surgery =< 14 days prior to enrollment
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Planned chemotherapy during radiosurgery
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Leptomeningeal metastases
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Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 2 | Aria Health | Philadelphia | Pennsylvania | United States | 19118 |
| 3 | Reading Hospital | Reading | Pennsylvania | United States | 19601 |
Sponsors and Collaborators
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
- Principal Investigator: Wenyin Shi, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 16D.651