- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184038
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Wenyin Shi, MD
- Phone Number: (215) 955-6702
- Email: wenyin.shi@jefferson.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Sidney Kimmel Cancer Center at Thomas Jefferson University
-
Contact:
- Wenyin Shi, MD
- Phone Number: 215-955-6702
-
Philadelphia, Pennsylvania, United States, 19118
- Not yet recruiting
- Aria Health
-
Contact:
- Shari Rudoler, MD
- Phone Number: 215-612-4300
-
Principal Investigator:
- Shari Rudoler, MD
-
Reading, Pennsylvania, United States, 19601
- Recruiting
- Reading Hospital
-
Contact:
- Terrence Cescon, MD
- Phone Number: 484-628-0900
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive care (SRS/SBRT, neurocognitive testing)
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.
|
Ancillary studies
Other Names:
Undergo SBRT
Other Names:
Undergo SRS
Other Names:
Undergo assessment of neurocognitive function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurocognitive function as measured by neurocognitive decline on a battery of tests
Time Frame: At 4 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 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 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.
|
Baseline to up to 12 months
|
Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)
Time Frame: Baseline to up to 12 months
|
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)
Time Frame: Up to 12 months
|
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
Time Frame: Up to 12 months
|
Will be measured by magnetic resonance imaging.
|
Up to 12 months
|
Progression free survival (PFS)
Time Frame: Up to 12 months
|
Each group will be evaluated using the Kaplan-Meier method.
|
Up to 12 months
|
Overall survival (OS)
Time Frame: Up to 12 months
|
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
Time Frame: Up to 30 days after SRS
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wenyin Shi, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16D.651
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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