Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Official title

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

Overview

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.

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.

Interventions

• Procedure Cognitive Assessment
  Undergo assessment of neurocognitive function
• Radiation Stereotactic Radiosurgery
  Undergo SRS
• Radiation Stereotactic Body Radiation Therapy
  Undergo SBRT
• Other Quality-of-Life Assessment
  Ancillary studies

Primary outcome measures

• Neurocognitive function as measured by neurocognitive decline on a battery of tests [Time frame: At 4 months]

Secondary outcome measures (7)

• 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]
• 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]
• 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]
• Local control as measured by magnetic resonance imaging [Time frame: Up to 12 months]
• Progression free survival (PFS) [Time frame: Up to 12 months]
• Overall survival (OS) [Time frame: 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]

Eligibility 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Jefferson Health New Jersey — Sewell
• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT03184038 · 16D.651 · JT 9331

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗