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Assessment of Neurocognitive Function in Patients With Multiple Brain Metastases Undergoing Stereotactic Radiosurgery or Stereotactic Body Radiation Therapy

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ClinicalTrials.gov Identifier: NCT03184038
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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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
Metastatic Malignant Neoplasm in the Brain Solid Neoplasm Procedure: Cognitive Assessment Radiation: Stereotactic Radiosurgery Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4.

SECONDARY OBJECTIVES:

I. Assessment of neurocognitive function at months 2, 6, 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
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:
  • Stereotactic External Beam Irradiation
  • Stereotactic Radiation Therapy
  • stereotaxic radiosurgery

Radiation: Stereotactic Body Radiation Therapy
Undergo standard of care (SBRT) Stereotactic Body Radiation Therapy
Other Name: SBRT


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall [ Time Frame: 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.

  2. Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall [ Time Frame: 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.

  3. Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recognition [ Time Frame: 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.

  4. Neurocognitive function as measured by neurocognitive decline on a Hopkins Verbal Learning Test-Revised (HVLT-R) for Trail Making Test (TMT) Parts A [ Time Frame: 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 :
  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 [ 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 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184038


Contacts
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Contact: Wenyin Shi, MD (215) 955-6702 wenyin.shi@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Wenyin Shi, MD    215-955-6702      
Aria Health Not yet recruiting
Philadelphia, Pennsylvania, United States, 19118
Contact: Shari Rudoler, MD    215-612-4300      
Principal Investigator: Shari Rudoler, MD         
Reading Hospital Recruiting
Reading, Pennsylvania, United States, 19601
Contact: Terrence Cescon, MD    484-628-0900      
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Wenyin Shi, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03184038    
Other Study ID Numbers: 16D.651
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases