Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Официальное название

The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins

Обзор

This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.

Вмешательства

• Процедура Stereotactic Radiosurgery
  The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)

Первичные конечные точки

• Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months [Срок оценки: 6 months]

Вторичные конечные точки (10)

• Progression free survival (PFS) rates estimated by the Kaplan-Meier method [Срок оценки: 2 years]
• Overall survival rates [Срок оценки: 2 years]
• Rates of radiation necrosis [Срок оценки: 2 years]
• Rates of pseudoprogression [Срок оценки: 2 years]
• Local failure rates [Срок оценки: 2 years]
• Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities [Срок оценки: 90 days]
• Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities [Срок оценки: 2 years]
• Rates of distant intracranial failure [Срок оценки: 2 years]
• Rates of salvage therapy [Срок оценки: 2 years]
• Association between dose and risk of radionecrosis or pseudoprogression [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
• Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
• Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
• Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
• Ability to understand and willingness to sign a written informed consent document.

Критерии исключения

• Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
• Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
• Diagnosis of leptomeningeal disease.
• Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
• Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
• Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR<30, gadolinium allergy).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Идентификаторы

NCT: NCT02747303 · IRB15-1476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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