Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Cognitive Assessment
  Undergo assessment of neurocognitive function
• Лучевая терапия Stereotactic Radiosurgery
  Undergo SRS
• Лучевая терапия Stereotactic Body Radiation Therapy
  Undergo SBRT
• Другое Quality-of-Life Assessment
  Ancillary studies

Первичные конечные точки

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

Вторичные конечные точки (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 [Срок оценки: Baseline to up to 12 months]
• Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT) [Срок оценки: 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) [Срок оценки: Up to 12 months]
• Local control as measured by magnetic resonance imaging [Срок оценки: Up to 12 months]
• Progression free survival (PFS) [Срок оценки: Up to 12 months]
• Overall survival (OS) [Срок оценки: Up to 12 months]
• Incidence of adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0 [Срок оценки: Up to 30 days after SRS]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

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

Идентификаторы

NCT: NCT03184038 · 16D.651 · JT 9331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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